Background and Objectives: Clinicians have been using elastic abdominal binder for stabilizing incision site after major abdominal surgery. However, the benefits of that practice have never been formally assessed. The aim of this study was to examine the effects of the use of elastic abdominal binder on postoperative pain and recovery of gynecologic cancer patients. Materials and Methods: One-hundred and nine women diagnosed with cervical, endometrial, or ovarian cancer, who underwent open abdominal surgery were assigned randomly into two groups: intervention (56 patients) and control (53 patients). The women in the intervention group applied abdominal binder from postoperative day 1. For the control group, the women did not wear the binder or similar devices. The primary outcomes were pain and functional recovery. Subgroup analysis on participants age ≥ 50 was also performed. Results: For the entire study cohort, the baseline, postoperative day 1, and postoperative day 2 pain scores in the intervention group were significantly lower than the control group. However, there was no significant difference between the groups for postoperative day 3 pain score and for the change in pain scores from the baseline value. Of note, the age ≥ 50 subgroup represented a more balanced cohort with comparable baseline pain scores between the study groups. For this population, the pain scores for postoperative day 1–3 were significantly lower in the intervention group. The intervention group had a longer six-minute walking distance on postoperative day 3 with a trend toward a smaller difference in the day 3 distance from the baseline. Conclusions: The potential benefits of abdominal binder use in reducing postoperative pain and improving functional recovery after open gynecologic cancer surgery could be demonstrated only in those age ≥ 50. Surgery is a major component of multidisciplinary care for gynecologic cancers . The priAbdominal binder is a broad elastic band that is applied around the patient’s torso at the level of the lower abdomen to provide support to the surgical incision after surgery. Clinicians have been using the binder for stabilizing the incision site, relieving incisional pain, improving mobility, and preventing wound complications such as seroma and hematoma . At our High-quality data on the effectiveness of abdominal binder use in this particular group of patients is lacking ,5,6. EarThe aim of this study was to examine the effects of elastic abdominal binder use on the postoperative recovery of gynecologic cancer patients focusing on postoperative pain, functional recovery, postoperative complications, and quality of life.We invited women aged 18–65 years, diagnosed with cervical, endometrial, or ovarian cancer, who underwent open major abdominal surgery at our institution from April 2018 to May 2019 to participate in this parallel group randomized controlled trial. For participants with cervical cancer, the operative procedures performed included radical (type B or C) hysterectomy and pelvic lymphadenectomy with/without para-aortic lymphadenectomy. For those with endometrial or ovarian cancers, total (type A) hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy, omentectomy, intraperitoneal biopsies, and tumor debulking (for advanced disease) were performed. General anesthesia induced by nitrous oxide, intravenous midazolam and fentanyl was employed in all patients. The anesthesia was maintained by inhaled anesthetics (desflurane/sevoflurane) and/or additional fentanyl. Combined general anesthesia with epidural anesthesia was used at the discretion of the attending anesthesiologist. The exclusion criteria were intraoperative accidental injury to urinary or gastrointestinal organs, the need for ostomy, postoperative admission to intensive care unit, postoperative intraperitoneal drain placement, unable to understand and follow oral/written instructions, and severe neuromuscular or circulatory disorders. The protocol of this study was registered with ClinicalTrials.gov (ID NCT03818633).At the time of procedure completion, the study coordinator randomly assigned the participants into two study groups, abdominal binder (intervention) and no binder (control). The computer-generated stratified randomization sequence by primary site of cancer was employed. The allocation assignments were placed in sequentially numbered sealed opaque envelopes to ensure allocation concealment.The day of operation was considered postoperative day 0. For the intervention group, each participant was fitted with an elastic abdominal binder starting on postoperative day 1 at 7 a.m. The participants were instructed and assisted to wear the binder snugly around their torso, on top of their hospital robe, with the incision positioned at the center of the binder band. We encouraged them to keep the binder on at all times during their hospital stay. Nevertheless, occasional breaks from binder wearing were allowed at the participants’ convenience. For the control group, the participants did not wear abdominal binder or similar devices. Standard postoperative care protocol and medication were provided uniformly to both study groups. All participants were encouraged to ambulate within 6 h after surgery and offered sips of water when fully awake. On postoperative day 1, liquid diet was started in the morning and, if tolerated, progressed to soft diet for the next meal and regular diet thereafter if desired. Regarding postoperative pain medication, the patients received either intravenous parecoxib every 12 h with intravenous morphine for breakthrough pain or patient-controlled analgesia (PCA) at the discretion of the attending anesthesiologist on the day of surgery and postoperative day 1 and 2. Oral diclofenac or tramadol in combination with acetaminophen was used thereafter as needed. Foley catheter was usually removed on postoperative day 1 given reasonable level of self-care and adequate urine output.Hospital discharge criteria included stable vital signs, no active ongoing postoperative complications, pain control with oral analgesia, good tolerance of oral soft diet, and return of the ability to carry on daily self-care.Primary outcomes for this study were postoperative pain and functional recovery. Secondary outcomes were quality of life and postoperative complications.We asked each participant to rate her visual analogue scale pain score at 6:00 a.m. on postoperative day 1. This was used as baseline postoperative pain score. Thereafter, we assessed pain scores twice daily at 10:00 a.m. and 6:00 p.m. The average of these two pain scores represented pain score for that day. The number and dosage of postoperative analgesics needed were also recorded. The difference in the pain score from baseline was calculated each day.Functional recovery was assessed by using the mobility aspect of the six-minute walk test. This is one of the best established, simplest, best tolerated, and most reflective technique of measuring daily activity among the methods for the evaluation of functional capacity . We perfFor the quality-of-life assessment, we administered the EuroQol Group’s EQ-5D-5L questionnaire on postoperative day 3 . The quaWe monitored postoperative complications, which included febrile morbidity, wound complications, and bowel ileus daily. We defined febrile morbidity as having a temperature of 38 degree Celsius or greater on two successive episodes, measured six hours apart using a standard technique, excluding the first 24 h following surgery. Wound complications included hematoma, seroma, and dehiscence. Clinically significant bowel ileus was diagnosed if participants had combined symptoms of severe nausea/vomiting, abdominal distention, and hypoactive bowel sound.A specially trained registered nurse recorded pain scores, performed the six-minute walk test, and acquired quality of life information through an interview session. The team of attending physicians responsible for gynecologic oncology postoperative recovery ward evaluated postoperative complications.We based sample size calculation on the primary outcome of the visual analogue scale pain scores. We chose a 2 cm difference between the study groups in visual analogue scale pain scores as the minimal effect that would be clinically meaningful . We set ® program version 15 . Continuous outcome variables  were expressed as median if the data distribution were skewed and mean if the data distribution were normal. We applied the Mann-Whitney U test or Student’s t-test, as appropriate, for hypothesis testing for difference in continuous outcomes between the study groups. Hypothesis testing for categorical outcome variables was performed by using chi square or Fisher’s exact test, as deemed appropriate. A p-value of < 0.05 was considered statistically significant.Statistical analysis was performed with StataIn addition, subgroup analysis on participants age ≥ 50 was performed given that this is the population that may benefit from earlier mobilization promoted by the binder use. Moreover, the benefit of increased number of ambulatory events in the first 24 h with the binder use was observed only in this particular group of participants in the previous study examining gynecologic patients .From April 2018 to May 2019, 120 eligible women agreed to participate and were randomly allocated into two groups, intervention (60 women) and control (60 women). Two patients, one from each study group, were excluded due to the need for postoperative intensive care unit admission because of perioperative medical issues . In addition, nine patients (three in the intervention group and six in the control group) refused to cooperate and requested to exit the study on postoperative day 1 without receiving the assigned intervention. The remaining 109 patients, 56 patients in the intervention group and 53 patients in the control group, participated in the allocated study groups through to the completion of the study .p = 0.07). Mean body mass indices were comparable, 24.7 kg/m2 in the intervention group and 25.8 kg/m2 in the control group (p = 0.26). Median incision length was 15.0 cm for both study groups. Median operative blood loss was 250 mL for the intervention group and 325 mL for the control group (p = 0.35). Median operative time was comparable, 177.0 min in the intervention group and 176.5 min in the control group (p = 0.69).p = 0.23). These findings remained the same in the age ≥ 50 subgroup.All dimensions of quality of life assessed by EuroQol Group’s EQ-5D-5L questionnaire including mobility, self-care, usual activities, pain/discomfort, and anxiety were not different between the study groups. Additionally, the visual analogue scores on overall health status were comparable, 80.0 (35.0–100.0) in the intervention group and 80.0 (45.0–100.0) in the control group (p = 0.04). For the 4 patients with complications, 2 patients had febrile morbidity and 2 patients had bowel ileus. Although there was no significant wound complication documented, visible blood stain on the wound dressing resulting from superficial oozing was observe in 3 participants (8.1%) in the intervention group and 5 participants (16.7%) in the control group (p = 0.45). Incidence of postoperative complications, mainly febrile morbidity was significantly higher in the control group.  Of the sWhen the entire study cohort was considered, the proposed benefits of postoperative abdominal binder use on pain reduction, mobility enhancement, and quality of life improvement could not be clearly demonstrated. The change in pain scores and six-minute walking distance from baseline was comparable between the intervention and the control groups. We observed significantly lower postoperative febrile morbidity in the intervention group. It is important to note, however, that the baseline postoperative pain score in the control group was significantly higher (3.8 vs. 2.4). Although not statistically significant, the larger amount of intraoperative blood loss (400.0 vs. 300.0 mL) and longer operative duration (191.0 vs. 178.5) suggested that participants in the control group might have had more difficult and traumatic surgeries. This difference in the baseline status between the study groups most likely occurred by chance. However, it substantially complicated interpretation of our results.Of note, when only the participants age ≥ 50 were considered, the baseline surgical characteristics of the two study groups appeared more comparable prior to assigning intervention. These characteristics included incision length, operative blood loss, operative time, and importantly baseline postoperative pain score. Interestingly, we found the association between the binder use and decreased pain scores on postoperative day 1–3 and reduced amount of postoperative consumption of parecoxib and acetaminophen. Furthermore, the longer six-minute walking distance on postoperative day 3 in those who used binder could represent faster physical function recovery. However, one should be cautious when interpreting findings from post-hoc subgroup analysis with rather small sample size.Although evidence supports early mobilization as an effective measure to prevent complications and encourage recovery following major abdominal surgery, most patients are reluctant to comply due to pain and the concern of breaking the incision ,7,19. TrPostoperative incisional pain has been the main contributing factor for limited mobilization after major open abdominal surgery as the incision moving along with the body by the pull of abdominal wall muscles greatly aggravates pain. This process leads not only to psychological distress but also stasis-related complications including pulmonary atelectasis from shallow breathing, bowel ileus, venous thromboembolism, and febrile morbidity. In principle, abdominal binder could stabilize the abdominal wall and minimize incision movement while the patients are ambulating. Procedure/incision characteristics, anesthesia, postoperative analgesia, co-existing medical conditions, and patients’ perception all play a part in postoperative pain severity ,7,8,13. Postoperative mobilization is directly influenced by the extent of physical trauma from surgery and the recovery from it. For an uneventful surgery, the effectiveness of pain control generally determines the ability to mobilize. In the literature, the beneficial effect of binder use on postoperative mobilization was apparent only in the studies that involved extensive procedures with concurrent positive effect on pain relief ,7. In SzTheoretically, improvement in pain control and mobilization would lead to decreased risk of complications. However, any significant effect of abdominal binder use on the incidence of postoperative complications has not been shown in the previous studies. Postoperative pulmonary function, in particular, was examined in many studies without demonstrable positive effect associated with the binder use. In this study, although we found significantly lower incidence of febrile morbidity in the intervention group, it is important to differentiate whether this positive outcome in the intervention group actually was the result of binder use or merely the consequence of the more complicated surgery experienced by the control group especially when all participants was considered. Again, our data only supported the possible benefit of the binder use in this regard only in the age ≥ 50 subgroup. The strength of this study was the prospective randomized controlled design with allocation concealment and good participant compliance. However, as noted above, the baseline postoperative pain scores were different between the groups when the entire study cohort was considered. In addition, some patients refused to continue participation after randomization and requested that they exit the project. The main reason for refusal to carry on with the project was personal and mostly related to decreased performance and unwillingness to cooperate with the protocol. Also, because of the nature of the investigation assessed, the participants were not blinded. With subjective outcomes like pain, this could lead to reporting bias. Furthermore, the sample size may not be adequate for detecting small but clinically significant difference in outcomes such as the change in the walking distance from the baseline and some less common postoperative complications. It should also be noted that the results of this study could not be directly generalized to those with ostomy.The potential benefits of abdominal binder use in reducing postoperative pain, improving functional recovery, and decreasing postoperative complications after major open abdominal gynecologic cancer surgery could be demonstrated only in the age ≥ 50 subgroup.


Pain is one of the most common and debilitating symptoms in cancer patients. A clinical peculiarity of cancer pain is the breakthrough cancer pain (BTcP), which is defined as a temporary exacerbation of pain that “breaks through” a phase of adequate pain control by an opioid-based therapy. The NP-BTcP occurs in the absence of any specific activity. In this paper, we addressed the topic through a mathematical approach to provide many indications for identifying the diagnostic and therapeutic gaps in NP-BTcP management.p < 0.001). Phenotype 1 was characterized by the gastrointestinal type of cancer (26.4%) with respect to phenotype 4, where the most frequent cancer affected the lung (28.8%) (p < 0.001). Phenotype 4 was mainly managed with rapid-onset opioids, while in phenotype 1, many patients were treated with oral, subcutaneous, or intravenous morphine . The ability to characterize NP-BTcP can offer enormous benefits for the management of this serious aspect of cancer pain. Although requiring validation, this strategy can provide many indications for identifying the diagnostic and therapeutic gaps in NP-BTcP management.Breakthrough cancer pain (BTcP) is a temporary exacerbation of pain that “breaks through” a phase of adequate pain control by an opioid-based therapy. The non-predictable BTcP (NP-BTcP) is a subtype of BTcP that occurs in the absence of any specific activity. Since NP-BTcP has an important clinical impact, this analysis is aimed at characterizing the NP-BTcP phenomenon through a multidimensional statistical technique. This is a secondary analysis based on the Italian Oncologic Pain multiSetting—Multicentric Survey (IOPS-MS). A correlation analysis was performed to characterize the NP-BTcP profile about its intensity, number of episodes per day, and type. The multiple correspondence analysis (MCA) determined the identification of four groups (phenotypes). A univariate analysis was performed to assess differences between the four phenotypes and selected covariates. The four phenotypes represent the hierarchical classification according to the status of NP-BTcP: from the best (phenotype 1) to the worst (phenotype 4). The univariate analysis found a significant association between the onset time >10 min in the phenotype 1 (37.3%)’ vs. the onset > 10 min in phenotype 4 (25.8%) ( Despite the many therapeutic possibilities, pain remains one of the most common and debilitating symptoms in cancer patients. Its prevalence is approximately 55% during anticancer treatment, 40% after therapy, and about 66% in the advanced and progressive phase of disease stages ,2. AlthoIn the 11th revision of the International Classification of Diseases (ICD), a task force of the International Association for the Study of Pain (IASP) has provided a new classification of chronic pain . It distBTcP is divided into two categories, including the predictable and the non-predictable BTcP (NP-BTcP) type. The predictable, or incident type, is further categorized into three subclasses, including the volitional BTcP (caused by a voluntary act), the non-volitional subtype (caused by an involuntary act), and the procedural pain. The NP-BTcP occurs in the absence of any specific activity. It is also indicated as spontaneous or idiopathic BTcP ,11.The clinical and therapeutic implications, and probably the pathophysiology, are very different. For example, since the predictable BTcP is usually triggered by voluntary  and not voluntary movements  or therapeutic procedures, adequate knowledge of the phenomenon can facilitate the prevention and implementation of effective therapeutic strategies. On the other hand, since it is not possible to establish its triggering events, the clinical and therapeutic implications of NP-BTcP are of fundamental importance. The idiopathic form has many aspects yet to be defined. However, since it accounts for about 70% of the total cases of BTcP  and is iThe study of the phenomenon can be performed through clinical investigations. Another strategy is the analysis of high sample size datasets using ad hoc statistical methods. On these premises, this work aims to characterize the NP-BTcP phenomenon through a multidimensional method applied to the most copious database collected so far.This is a secondary analysis based on the Italian Oncologic Pain multiSetting—Multicentric Survey (IOPS-MS) that was carried out for dissecting the BTcP phenomenon ,7. DetaiAge greater than 18 years;Diagnosis of cancer at any stage; well-controlled and stable background pain with an intensity ≤ 4 ;Presence of BTcP episode of moderate–severe intensity, clearly distinguished from background pain.Inclusion criteria were:No cancer diagnosis;Unstable and/or uncontrolled background pain (>4/10);No relevant peaks in pain intensity (<5/10);Poor collaboration or refusal to participate.Exclusion criteria were:Considering that in spontaneous BTcP, more than 3–4 episodes per day usually indicate uncontrolled background pain  ,7,11,12,Among all recorded variables from the original study, some variables were selected for this secondary analysis: age, gender, setting, type of primary tumor, onset, type of BTcP pain, Karnofsky status, and type of physician were recorded. Patients were asked about the average time of meaningful pain relief after their BTcP medication . The study was observational, and pharmaceutical therapies were used according to local policy, without following strict protocols.n = 4016 cases were entered. Of these, 30.5% (n = 1225) were incident BTcP and 69.5% (n = 2791) NP-BTcP [In the original IOPS-MS dataset, .5% n = 291 NP-BTc(a)BTcP intensity score (NRS 5–10) (quantitative discrete variable).(b)Number of BTcP episodes per day (1–4) (quantitative discrete variable).(c)Duration of BTcP (quantitative continuous variable).Descriptive statistics were provided for BTcP characteristics and main variables. At first, to characterize the BTcP profile, a Pearson correlation was performed among the following quantitative discrete/continuous variables:a and b variables; p < 0.001) and by adding the categorical variable “BTcP type” , a multidimensional analysis was performed. The multiple correspondence analysis (MCA) determined the identification of groups (termed as ‘phenotypes’). The MCA plot showed the theoretical clusters, and a further confirmative hierarchical clustering principal components analysis (HCPC) [By selecting the quantitative discrete variables with the highest correlation (s (HCPC)  was impls (HCPC) . It is ap-value less than 0.05 was considered statistically significant  from the original study, 120 presented more than four episodes per day. Those patients were excluded from this secondary analysis; thus, 95.7% of the total set was analyzed (n = 2671).Among patients with NP-BTcP (Patients’ characteristics are described in MCA finding was shown in 6 = 509.13). The k-means method, represented by the Elbow plot (4 = 838.93). According to cluster estimation, the agreement between induced classification and automatic classification was 31.6%.An automatic procedure recognizes the six theoretical clusters groups . A significant association was assessed between the onset time >10 min in phenotype 1 (37.3%) vs. the onset >10 min in phenotype 4 (25.8%) (p < 0.001); inpatients were mainly allocated into cluster P4, while those in palliative care settings who expressed phenotype 1 . About cancer type, P1 was characterized by gastrointestinal (26.4%) respect to P4, where the most frequent cancer affected was the lung (28.8%) (p < 0.001).The univariate analysis shows the associations between the four phenotypes and selected variables . A bordep = 0.008). Moreover, the number of patients who did not receive therapy  decreased from P1 to P4  (Phenotype 4 was mainly managed with rapid-onset opioids (ROOs), while in phenotype 1 many patients were treated with oral, subcutaneous, or intravenous morphine  .To our knowledge, this is the first study aimed at characterizing the NP-BTcP phenomenon. Several pieces of evidence showed that BTcP cannot be intended as a single nosological entity but includes different and changing pathogenetic mechanisms justifying its sub-typing ,9,17. CoThe main challenge for BTcP management is the implementation of new procedures that can be useful for both diagnostic and therapeutic approaches. Recently, Pantano et al.  performe4 = 838.93). For all these reasons, the goodness of fit was 32%, which represents the explained variation of the entire phenomenon. Furthermore, it must be considered that the model was based on three variables and large sample size. According to the hierarchical order assumed by the phenotypes, it was easier to recognize the best group (P1) versus the worst one (P4).Subsequently, the characteristics assumed by the individuals in each group were projected. In turn, a rule of classification was developed . This apThe data emerging from the categorization indicate that P1 expresses nociceptive pain. Although even four episodes per day can occur, the NRS (0–10) is of intensity between 5 and 6. On the other hand, P4 is characterized by episodes of neuropathic pain or both pains of severe intensity. The intermediate clusters (P3 and P4) may have a nociceptive type of NP-BTcP but of high intensity, or they express neuropathic pain/both pains of submaximal intensity.Subsequently, the univariate analysis showed that phenotype 1 is characterized by older age, slow onset, gastrointestinal as primary tumor, and greater propensity to be treated in the context of the palliative care setting. On the contrary, the main features of phenotype 4 are younger age and rapid onset; furthermore, it most frequently concerns inpatients affected by lung cancer. Moreover, regarding the NP-BTcP therapy, the worst phenotype (P4) was mainly managed with ROOs; on the contrary, in phenotype 1 many patients were treated with oral, subcutaneous, or intravenous morphine. Interestingly, guidelines on cancer pain treatment do not refer to the severity of BTcP and provide different guidance regarding its treatment. For instance, the European Society for Medical Oncology (ESMO) guidelines recommended the use of fentanyl formulations for the treatment of BTcP . In the same guidelines, morphine received a level of evidence of II and a degree of recommendation of B . On the A great concern is the lack of treatment of NP-BTcP for each phenotype. Notably, about 17% of patients in P1 did not receive any treatment and, even if this percentage decreases up to P4, there is a statistically significant difference compared with those who received ROOs, morphine, and all other therapies. Despite the guidelines on the topic, proper cancer pain treatment remains a paramount unmet medical need for cancer patients ,23.The ability to characterize NP-BTcP can offer enormous benefits for the management of this serious aspect of cancer pain , facilitParticular care perspectives are very interesting. The possibility of developing a mobile application to quickly allocate the patient in one of the four clusters is one of these perspectives. This method could implement systems already in use or being tested. The Pain Assessment in Cancer Patients by Machine Learning (PASCALE) study (NCT04726228) is ongoing; it is aimed at evaluating the possibility that telemedicine can improve the quality of life of cancer patients through self-management and remote monitoring solutions. The study involves the development of an application that also records information on the BTcP features. After the first phase of implementation of the database and machine learning for identifying objective characters of pain, the authors plan to include the four clusters to study multiple features of NP-BTcP .In addition to experimental approaches, telemedicine tools could be used to assist those patients who are immediately allocated to the worst clusters (P3 and P4). For these patients, the management of NP-BTcP must be very aggressive to counteract its impact on the quality of life.If adequate resources are available, even the so-called best phenotypes (P1 and P2) can benefit from telemedicine. The experience accumulated in the management of patients with cancer pain during the pandemic suggests that many episodes of NP-BTcP are not reported during periodic consultations but are recorded by the patient in the monitoring system . In otheThis study has multiple limitations. The most important limitation concerns the assumption that it is a secondary analysis based on a survey. However, our starting point remains the most abundant dataset on the subject. Moreover, the original IOPS study was not drawn to perform this analysis. This gap could be overcome by the development of prospective studies to verify the reliability  of the proposed classification system . AnotherThe idiopathic form of BTcP has many aspects yet to be defined, and the characterization of the phenomenon means being able to improve its management. In-depth knowledge is also mandatory because NP-BTcP accounts for over two thirds of all BTcP cases. While waiting to obtain data from prospective studies, dataset analyzes carried out according to ad hoc statistical approaches can allow us to define clusters (phenotypes) that differ in the type of pain, intensity, and number of daily episodes. It can be deduced, for instance, that those suffering from lung cancer may be classified in the worst phenotype of NP-BTcP (P4), and this prerequisite presupposes greater diagnostic attention. Finally, a more precise definition of clusters could lead to important therapeutic perspectives. For example, a mobile application could be useful for the clinician to frame individual patients. To be more precise, patients who fall into the worst phenotypes could be followed up under telemedicine programs. The aim is to provide tailored management of the NP-BTcP through designing prospective studies for the validation of this multidimensional statistical approach.


Considering the wide impact of endometriosis on various aspects of health, this study aimed to explore the impact of endometriosis on Iranian women's lives.The present study used a qualitative approach and conventional content analysis.Twenty patients suffering from endometriosis referring to Imam Khomeini Hospital in Tehran took part in this study. The sampling was done purposefully until data saturation. After deep semi‐structured interviews, the content analysis of the interviews was done according to the steps proposed by Zhang and Wildemuth.SD: 5.81) years (range: 23–43) with duration of illness of 6.30 ± 5.86 years. Their educational level varied from high school to university, and most of them were employed. Analysis of the data from participants' experiences led to the formation of 5 categories under the titles "Physical suffering, instability of marital life, mental disorder, disruption in social life and self‐care" and 11 subcategories.The mean age of the participants was 34.53 (The findings of the present study showed that endometriosis can adversely affect women's lives including physical, sexual, psychological and social problems. Although in some cases patients adopt different strategies for self‐care, the need for more support is felt. It is eDespite the high morbidity of endometriosis and the high cost of its health care, the precise aetiology of the disease is still unclear and only a few risk factors have been identified  and definitive diagnosis of the disease through laparoscopy. The exclusion criteria were unwillingness to participate in the study and other causes of pelvic pain. In this study, the data were saturated with 17 people, but we also interviewed 3 others for more certainty. Written and informed consent for participation in the research was obtained from the participants. They were assured that they could withdraw from the research whenever they wished, and all their information would remain confidential. Data collection was done through individual in‐depth semi‐structured interviews. The face‐to‐face interviews were held in a dedicated room, and each lasted between 45–90 min. Interviews started with questions such as "What is your experience of life with endometriosis?" and "What effect did endometriosis have on your life?" and continued with exploratory questions such as "What do you mean?", "How?", "Why?" and "You may explain more about this." Interviews were recorded with the permission of the patients, and on the same day, each interview was written word‐for‐word and then coded, and after the analysis of each interview, the next interview was carried out.To determine the rigour of the qualitative data, Lincoln and Guba's criteria were used, including credibility, dependability, conformability, transferability and authenticity of the data : In this stage, the recorded interviews were converted to text format. All interviews were transcripted to reveal a clear model of the thoughts, behaviours, ideas and experiences of the study participants.Defining and categorizing data analysis units: Each interviewed text was entered into qualitative data analysis software as a unit of analysis. Before coding, the entire text of the interview was read several times so that the researcher was fully acquainted with the data. They were then coded by specifying meaningful units.Specifying categories and patterns of data coding: At this stage, a pattern was designed to develop categories and subcategories. Categories were extracted from codes inductively. The codes were first placed in subcategories due to similarity, and then, the subcategories formed a category based on their relationship to each other. The categories were organized in such a way that they had internal compatibility and external incompatibility.Evaluation of the sample coding pattern: For this purpose, the researcher coded a sample of text to control the consistency of the coding by two members of the research team. Discrepancies in the rules regarding coding or classification of codes were resolved through discussions between the research teams.Coding the full text of the interview: After the researcher and two members of the research team agreed on coding stability, a reproducible process was achieved and the coding process was extended to the whole text. During the coding process, the researcher continuously monitored the coding to ensure that there was agreement between the extracted codes based on the researcher's inference and the views of the study participants and the research team.Evaluating the coding stability: After full‐text encoding, the coding stability was checked again. During the analysis process, the researcher controlled the consistency of the coding, including the primary codes, their placement in the subcategories and the formation of categories with other people, including two members of the research team and experts in qualitative research.Extracting the results from the coded data and reporting them: At this stage, the characteristics and dimensions of the categories were discovered and the relationships between them were identified  was used for data analysis.3.2Sampling was done after approval from the research council of the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences and obtaining permission from the Ethics Committee of this university .4Participants included 20 married patients with endometriosis who were diagnosed with laparoscopy. The age of the participants was between 23–43 years, and the mean age was 34.53 ± 5.81 years. Other demographic characteristics of the participants in the study are presented in Table 4.1This category includes two subcategories of menstrual disorders and disabling pelvic pain.(Participant No. 4).My hemorrhage is very severe during my period, I can't even move dithe bathroom repeatedly 1–1. Menstrual disorders: Patients suffered from severe bleeding and clotting, spotting before and after menstruation and irregular menstruation. Severe bleeding and clotting were reported by most participants. For example, patients expressed the following:(Participant No. 7)Two days before the period, I see brown spots and it last until after of menstruation. For example, if my period lasts for 7 days, then I have a spotting for seven days after it. Spotting before and after menstruation was one of the other common problems raised by the participants in the research:(Participant No. 2)My periods are very irregular. Each month, a few days back or forth. y periods are not predictable at all The irregular menstruation was also another complaint raised by the participants:(Participant No. 15)During the period under my belly was very painful, pain was very severe and not tolerable at all 1–2. Disabling pelvic pain: Patients suffered from severe pain in the waist and abdomen, pain in the ovaries and vague pelvic pain: (Participant No. 3)I feel my ovary is exploding, I can't do anything, I just cry (Participant No. 12)My pain starts from the middle of my stomach, then it spreads around my abdomen and my lower back and legs. Another participant said: (Participant No. 5)My pain was so terrible, I did not like to be alive, I was very annoyed, I had to go to the hospital when I had pain, It was so hard to breathe, I wanted to die Most people described the pain as unbearable: (Participant No. 20)I was hospitalized for the very pain that I had at the time of the period and I did not get rid of any pain, so that I had to take morphine. The severity of these pains in some people was not resolved by painkiller: 4.2(Participant No. 17)When your husband does not support you and most importantly, he does not pay for the treatment, it's very difficult. The problem is, on the one hand and these collisions on the other side This category consisted of two subcategories of emotional tension with the spouse and sexual dissatisfaction. 2–1. Emotional tension with the spouse: Some participants suffered from the lack of husband support during the course of the illness: I constantly say to my husband that we should be separated and I feel that my husband is so annoyed because of my illness. After divorce, my husband gets comfortable. (Participant No. 16)Some people also blamed themselves and, therefore, tended to be separated from their husbands: "During my intercourse, I have a lot of pain that I can't bear at all, this pain lasts even a few days" (Participant No. 6), and also decreased libido, inability to achieve orgasm and reduction in the number of intercourses from other sexual problems mentioned by the participants in the study:(Participant No. 14)It's so annoying that I have no desire for intercourse at all. (Participant No. 2)During intercourse, I have pain so much that I never enjoy it (Participant No. 7)I've spotted before and after the period for a few days and therefore I can't have intercourse. The number of my intercourses has dropped, which makes me very annoyed 2–2. Sexual dissatisfaction: One of the most common problems is pain during intercourse: 4.3This category consisted of three subcategories: frustration, self‐ condemn and feeling of repeated failure.(Participant No. 5)My illness recurs repeatedly. I was looking for treatment, but the treatment did not work. I was disappointed with the treatment of the disease 3–1. Frustration: Frequent recurrence of illness and lack of response to medical and surgical treatments to reduce the complications of the disease has been a disappointment in some patients:(Participant No. 19)I tried all the techniques of fertility, but it did not work. I'm disappointed with having a child. Some people have also been disappointed with having a child:(Participant No. 14)I compare myself with others, seeing others easily getting pregnant, not having problems. I compare myself with them. 3–2. Self‐ condemnation: Some people suggested that many complications of the illness made them compare themselves with others:(Participant No. 12)Sometimes I think I have weakness due to endometriosis and I can't be a mother, so I feel I’m different from others. The suffering of disease‐induced infertility has led some to consider themselves different from other people: (Participant No. 9)I have undergone surgery for several times, but my illness is recurring. (Participant No. 17)I got married three years ago and did not prevent pregnancy at all but did not get pregnant, the doctor told me that the cause of my infertility is the adhesion of the uterine tubes (Participant No. 18)I've done hysteroscopy twice, IUI several times and IVF twice, but none of them was successful 3–3. Feeling of repeated failure: Feeling of failure in patients with endometriosis can be due to various causes such as recurrence of illness, infertility and failure of assisted reproductive technologies (ART). Participants stated:4.4This category consisted of two subcategories: isolationism and disruption in daily activities.(Participant No. 2).My husband's family does not understand me at all. My mother‐in law always asks me when I want to have children. So, I would prefer not to see them (Participant No. 1).At work, my colleagues do not understand my condition at all. I have to take leave to follow up treatment, but in most cases, my chairman disagrees with the leave request 4–1. Isolationism: Patients stated that due to lack of understanding of the illness by relatives and colleagues they prefer to be alone:"When I have pain, I can't do anything at all. My husband does the homework " (Participant No. 2). The severity of bleeding and pain in some people was such that the need to rest at home was unavoidable for them: "My bleeding and pain during Menstruation is so much, which I can‘t go to work at all." (Participant No. 18).4–2. Disruption in daily activities: The severity of dysmenorrhoea was, in some people, so much that it caused their inability to do the routine activities: 4.5This category consisted of two subcategories: lifestyle change and pain management.(Participant No. 6)I search the net about the illness and its complications. When I have more information about the disease, I feel less stressful. 5–1. Lifestyle change: Participants in the study had adopted different ways of changing lifestyles. Some suggested that getting information about the disease and its nature made it less stressful:When I'm doing work, I do not even have the opportunity to think about the disease. (Participant No. 13).Some were also entertaining themselves with the job: (Participant No. 9)Every day I go to the park, exercise and walk. If I stay at home I blame myself. So, I try to do something. (Participant No. 20)I have a few friends who are very close and we go out together. So, I think less about my disease. Exercising and walking, as well as travelling with friends, constitute other ways of self‐care in these patients:(Participant No. 3)My friend introduced me to a doctor of traditional medicine. He gave me a series of herbal remedies, since then, I feel less pain. 5–2. Pain management: Patients used different ways to reduce pain. For example, some have turned to traditional medicine:(Participant No. 5)During the period I like to use water therapy, I like to get warm water on my skin. I feel my pain subsides (Participant No. 19)When I'm in pain, I put a warm towel on my waist and my abdomen. Water therapy and heat therapy were also other methods of managing pain in patients:5The present study aimed to explore the impact of endometriosis on Iranian women's lives. The results showed that endometriosis can adversely affect women's lives including physical suffering, instability of marital life, psychological disorder and disruption in social life. Physically, endometriosis causes menstrual disorder, including severe bleeding and clotting, spotting before and after menstruation and irregular menstruation. These results are in line with the findings of other studies  classification is not done in Iran, we were unable to categorize patients in the present study. The main strength of the present study lays in exploring the impact of endometriosis on women's lives. However, this strength is undermined by the generalizability issue inherent to qualitative studies.6The findings of present study showed that endometriosis can adversely affect women's lives including physical, sexual, psychological and social problems. Although in some cases patients adopt different strategies for self‐care, the need for more support is felt.The authors declare that they have no competing interests.Masoumeh Namazi: Substantial contributions to conception and design of data; Armin Zareiyan and Mina Jafarabadi: Revision of the manuscript critically for important intellectual content; Zahra Behboodi Moghadam: Final approval of the version to be published. Zahra Behboodi Moghadam: Accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.


Reducing side effects of cancer treatments is a major challenge for clinicians involved in the management of breast cancer patients. Among patients receiving neoadjuvant chemotherapy followed by surgery, radiotherapy and endocrine therapy, prolonged side effects frequently mentioned are: polyneuropathy, musculoskeletal pain, postoperative pain and cancer-related fatigue. Conventional drugs have proven to be ineffective in treating theses effects, except for postoperative pain. This is the reason why we prospectively tested the impact of hypnosis sedation used as anesthetic technique for breast cancer surgery on the different side effects of cancer treatment. Despite the limitations of this small non-randomized cohort, preliminary results are very encouraging.p < 0.05), musculoskeletal pain (p < 0.05) postoperative pain and cancer-related fatigue (p < 0.05) in the hypnosis group. Conclusion: Despite the limitations of this study  we conclude that hypnosis sedation may exert a role on different side effects of breast cancer treatment in patients receiving neoadjuvant chemotherapy, mainly by reducing their duration.Background: Reducing side effects of cancer treatments is a major challenge for clinicians involved in the management of breast cancer patients. Methods: We analyzed data from 63 patients  who were included in 1 prospective non-randomized trial evaluating hypnosis sedation in breast cancer treatment. The patients were followed every 3 months for 2 years. All patients received neoadjuvant chemotherapy with 4 cycles of epirubicin and cyclophosphamide followed by taxanes. Thereafter, patients underwent surgery while on general anesthesia or while on hypnosis sedation. Radiotherapy was administered according to institutional guidelines. Endocrine therapy was prescribed if tumors expressed hormone receptors. Prevalence, intensity and duration of polyneuropathy, musculoskeletal pain, postoperative pain and cancer-related fatigue were assessed at each medical visit. Results: Symptoms duration was statistically reduced for polyneuropathy ( Breast cancer is the most frequent cancer in women, and the second primary cause of cancer-related deaths. During the last decade, multidisciplinary approach and therapeutic progress have increased overall survival. However, survival benefits have a price. Side effects of anticancer treatments exert deleterious effects on quality of life. As an increasing number of patients are surviving breast cancer, it is of major importance to preserve the best quality of life and thus to reduce therapy-induced side effects ,2. In thPolyneuropathy—also called chemotherapy-induced peripheral neuropathy—is a common neurotoxic effect of antineoplastic agents such as taxanes. It refers to pain in the extremities associated with positive and/or negative symptoms like paresthesia and numbness ,6,7,8,9.Musculoskeletal pain is clearly associated with endocrine therapy but also described during and after administration of chemotherapy. Musculoskeletal pain refers to pain originating from or resembling arthralgia and/or myalgia .Postoperative pain needs to be carefully evaluated and treated. It concerns pain located in the surgical area: breast in case of conservative approach, chest wall in case of mastectomy, shoulder and arm. The perioperative period appears as a key time point to prevent the development of chronic pain after the classical period of postoperative pain . PersistCancer-related fatigue (CRF) is one of the most commonly reported symptoms impacting cancer survivors. CRF is estimated to occur in up to 90% of patients during active treatment and 27 to 82% of patients after treatment. CRF is defined as multidimensional and distressing fatigue related to cancer and/or cancer treatment that interferes with activities of daily living ,21,22,23Advances in pharmacology are certainly required to reduce postoperative pain and its transition to chronicity. In addition, innovative approaches are needed to reduce the incidence of CRF, PNP and MSP, for which a purely pharmacological approach has proven particularly disappointing.clinicaltrials.gov with NCT03330717.Patients were recruited from 1 study performed in our breast clinic  and in the Breast Clinic, Hopital de Jolimont, conducted to evaluate the benefits of hypnosis sedation in breast cancer patients undergoing oncologic surgery. Thereafter, substudies focused on benefits of hypnosis according to different modalities of received treatments such as neoadjuvant chemotherapy. This study was a non-randomized trial approved by our 2 local ethics committees  and complied with the Declaration of Helsinki. It was registered on clinicaltrials.gov in October 2017 when we decided to open the second center; the first patient of the multicentric study was enrolled in November 2017 and the study was completed at the end of 2019. It included 284 patients. A total of 63 patients received neoadjuvant chemotherapy: 32 in the group of general anesthesia and 31 in the group of hypnosis sedation. Written informed consent was obtained from all patients.This study was a prospective study registered in Belgium on the clinicaltrials database and registered on n = 25) and general anesthesia preceded by a session of virtual reality  We are aware that this study presents different biases. It could not be randomized because of the distressing context of a recent breast cancer diagnosis. Highly motivated patients who wanted to undergo breast surgery while on hypnosis sedation were not ready to participate in a randomized trial. On the contrary, patients afraid of this technique did not want to take the risk of breast surgery while on hypnosis sedation. Because of the small sample size of the cohort, we only considered 2 arms: general anesthesia (n = 32) and hypnosis sedation (n = 31).Because of interesting results observed in a first observational study , we retaEligible patients were patients included in our prospective trial who had neoadjuvant chemotherapy as initial treatment for their breast cancer. A majority were treated with 4 cycles of epirubicin-cyclophosphamide (EC) followed by 12 cycles of weekly paclitaxel, while 10 patients received 4 cycles of EC followed by 4 cycles of docetaxel. A total of 63 patients were evaluated. Twenty patients received trastuzumab during the paclitaxel administration. Dose dense administration of EC was given to 50 patients, with support of G-CSF, and 13 patients received were administered EC every 3 weeks, without support of G-CSF.In both groups, patients were evaluated before surgery during a preoperative anesthesiology consultation. The modalities and the course of the procedure were extensively described to patients. In this study, no patient requesting hypnosis sedation was refused ,2.Clinical data such as medical factors were gathered from medical records reviewed by trained research assistants. When performing measures of the different parameters, they were not aware of the allocated group in which patients were included.This substudy dedicated to patients receiving neoadjuvant chemotherapy focused on 4 side effects: polyneuropathy, musculoskeletal pain, postoperative pain and cancer-related fatigue. The main objective was to study the duration of the different side effects in the two groups. The secondary objectives were to evaluate the prevalence and the severity of the different side effects. No drop out was observed during the follow-up period. Only one patient in the GA group prematurely stopped her endocrine therapy. We considered this study as a “preliminary prospective study” whose aim was to attest the benefits of hypnosis sedation on different side effects of anticancer treatments.2], and capnography). Local anesthesia was performed with a combination of levobupivacaine 0.25% and lidocaine 1%. Oxygen was administered to each patient. Once they were comfortably installed on the operating table, the anesthesiologist induced hypnosis as a procedure where indirect suggestions were given on the anesthesiologist’s observation of patient’s behavior, and on her or his judgement of the patient’s needs. The patients were invited to fix a point in front of them while concentrating on their body to achieve total muscle relaxation before finally closing their eyes. Guided by the anesthesiologist, the patients had to focus their attention on a positive recollection. By using a calm and monotonous voice, the anesthesiologist constantly talked to help them relive a dream or experience so that they remained as detached and dissociated as possible from the reality surrounding them. A state of intense well-being and comfort had to be reached and maintained during the whole procedure. The peri-incisional skin is injected with a local anesthetic such as 0.5% lidocaine combined to 0.25% levobupivacaine. A continuous infusion of remifentanil, a µ-opioid agonist, was started at a rate of 0.05 µg/kg/min  and was modified or stopped as required. If needed, small doses of midazolam were administered, 0.1 mg at a time if an anxiolytic was needed. A preestablished communication system between the anesthesiologist and their patients allowed them to express any discomfort. In such a case, the hypnotic state was strengthened, the surgeon could improve local anesthesia, or the infusion rate of remifentanil could be increased. Once the procedure was completed, the anesthesiologist gave the patients recommendations (posthypnotic suggestions) in order to preserve their comfort in the postoperative period, to have correct healing, to keep the wound dry, and to give the patient the opportunity to reuse hypnosis during their cancer treatment. In both groups, patients were evaluated before surgery during a preoperative anesthesiology consultation. In the HYP group, patients received specific explanations about hypnosis sedation. During this session, the modalities and the course of the procedure were described to patients, and physicians confirmed that they were adequate candidates for this kind of analgesia and anesthetic procedure, i.e., that they were able to sign an informed consent form and able to understand the languages spoken in our institution. No patient requesting hypnosis sedation was refused. One hour before surgery, premedication with lorazepam (0.5 mg) was proposed to the patient. At the time of the surgical procedure, all the patients were monitored classically  of propofol (2–3 mg/kg), with lidocaine hydrochloride (1 mg/kg) ketamine hydrochloride 0.3 mg/kg, and sufentanil of 0.1–0.2 µg/kg and cis-atracurium if necessary. The airway was secured with an endotracheal or supraglottic tube, and the lungs were ventilated with a mixture of oxygen and air (50%-50%); The tidal volume was set at 6–8 mL/kg ideal body weight. Anesthesia was maintained with intravenous administration of propofol (Target controlled infusion devices), and additional intravenous sufentanil citrate (5 µg) was administered during surgery if the heart rate or surgical blood pressure increased by more than 20%. In the days after surgery, pain was controlled following the institution’s protocol: paracetamol 1 g/6 h and naproxen 500 mg/12 h in case of low pain, tramadol 50 mg/6 h in case of mild pain, and piritramide 20 mg/12 h in case of severe pain. Those medicines were given to patients as required.Patients receiving a virtual session of hypnorelaxation were allocated to the general anesthesia group. The program was administered just before entering the operating room. This program of Oncomfort is named AQUA and corresponds to an immersion in an aquatic environment. The short duration of the session (20 min) is probably responsible for the absence of observation of positive impact on side effects. That is the reason why patients were separated in two groups: general anesthesia and hypnosis sedation.During administration of chemotherapy, patients were evaluated for polyneuropathy at each course of chemotherapy. They were followed according to the classic procedures used as standard of care in our institution. The questions included the presence and persistence of paresthesias and tingling or pain in fingers or toes .If the answer was yes, severity was assessed and classified between mild, moderate and severe . After sQuestions were repeated at each follow-up visit and the responses were collected by the study’s physician investigators.In our institution, all patients were evaluated for acute pain during the postoperative period in an attempt to adequately treat acute postoperative pain and avoid chronicization of pain . EvaluatMusculoskeletal pain is linked to the administration of endocrine therapy and especially to aromatase inhibitors use, with or without Gonadotropin-Releasing Hormone (GnRH) agonists .This type of pain was recorded at each medical visit and also measured by Numerical Pain Rating Scales and Visual Analog Scales. The measurements were carried out by the study’s physician investigators.As it is a subjective experience, CRF is measured most efficiently via self-report, and recent observations and analyses suggest that a 10-point Numerical Rating Scale (NRS) for fatigue is the best screening tool. There is an agreement that fatigue intensity is graded as mild with scores of 1–3, moderate between 4 and 6, and severe between 7 and 10 ,23. The https://www.r-project.org, accessed on 24 May 2021) [p values < 0.05 were considered as statistically significant.Data were analyzed using the R Core Team software, 2021  in the GA group and 58% (18/31) in the HYP group. No statistical difference was noted between the two groups of patients. Among the patients suffering from PNP, 3 patients had severe symptoms in the GA group and 2 in the HYP group. The severity of the symptoms required premature interruption of taxanes administration in 5 patients. Two patients had received 10 courses of paclitaxel, 1 patient had received 9 courses, and 2 patients had received 3 cycles of docetaxel. The duration of PNP was statistically reduced in the HYP group: p < 0.05.The incidence of MSP was 46% (15/32) in the GA group and 29% (8/31) in the HYP group. The incidence and intensity of pain were not statistically different between the two groups but the duration of this symptom was also reduced in the HYP group: p < 0.05. POP was mentioned by all patients on day 1 but severity was lower in the HYP group: 0/31 severe and 0/31 moderate pain. On the contrary, in the GA group, 16 patients described moderate pain and 16 mild pain. On day 8, 31/32 patients of the GA group were still consuming non-steroidal anti-inflammatory drugs while in the HYP group only one patient took the same drugs. Pain intensity was significantly reduced in HYP group on days 0, 1 and 8 . Duratiop < 0.05.CRF was cited by all patients at the end of neoadjuvant chemotherapy, but like for the other studied side effects, the duration was statistically reduced in the HYP group: As soon as women are diagnosed with breast cancer, their quality of life is affected: sadness, anxiety, fatigue and depression are symptoms presented by breast cancer patients that lead to a decreased quality of life . TypicalThe major limitations of this study are the small number of included patients and the fact that this study is not randomized ,2. In ouThe positive points of this study are represented by a very regular follow-up during the administration of neoadjuvant chemotherapy, the perioperative period and radiotherapy. Thereafter, the follow-up period is very carefully monitored and identical for all patients. In general, large prospective randomized trials dedicated to neoadjuvant therapies do not focus on late side effects of cytostatic agents. On the contrary, in this study, late toxic side effects were taken into account.Neuropathy, also called chemotherapy-induced polyneuropathy, is a disabling side effect of chemotherapy which may greatly affect patients’ quality of life ,5. The iNo therapies are approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) to prevent or treat chemotherapy-induced polyneuropathy ,27. Drugp < 0.05). Pain severity was also significantly reduced in the HYP group (p < 0.05), according to the time point of pain measurement This observation confirmed data highlighted in our observational study [Postoperative pain (POP) is a very important parameter which needs to be taken into consideration ,14,15,16al study . These dal study ,34. Thisal study ,19. In tal study . In thisal study ,36,37.In a recent study published by Forget , the authors reported an incidence of permanent pain at one year comprised between 65 and 75% and incidence of persistent pain between 59 and 63% at two years . The autIn our study, immediate postoperative pain was well-controlled with pure analgesic and anti-inflammatory drugs. In the HYP group, the duration of POP was statistically reduced and consumption of anti-inflammatory drugs limited to day one post-surgery, except for one patient suffering from polyarthritis. It is well recognized that shortened duration of POP is a very important parameter to avoid persistent pain after breast surgery. As mentioned in the study of Forget, the location of POP changes after one and two years and it sometimes becomes difficult to characterize pain . IntricaConcerning musculoskeletal pain, in the Matox project  and in oIn a recent review, Fabi reported that 40% of patients mentioned fatigue at cancer diagnosis . Eighty A possible explanation of reducing the duration of PNP, POP, MSP and CRF in the HYP group is the fact that we have demonstrated in our prospective study   that hypInflammation is implicated in different types of studied pain: polyneuropathy, postoperative pain and musculoskeletal pain, and its role is suspected in the concept of cancer-related fatigue . Thus, rHypnosis has already been used successfully in metastatic breast cancer to relieve pain. In the adjuvant setting, hypnoanalgesia has been shown to reduce the intensity of the side effects induced by radiotherapy  (fatigueThese encouraging results open the door to new research protocols evaluating in a randomized way the effectiveness of hypnosis from the initiation of neoadjuvant treatments.The side effects analyzed in this study can have a prolonged duration and profoundly alter the quality of life of patients. It is therefore particularly important to develop a holistic view to manage these side effects and reduce their duration and intensity ,57. UnfoWe are aware of the limitations and selection bias of our study but nevertheless, we think that the highly promising obtained results open the door to the design of new prospective trials.Hypnosis certainly has its place and deserves to be studied in large randomized trials: hypnosis sessions proposed before each course of chemotherapy versus sham procedures. In order to study its mechanisms of action, biomarkers not influenced by chemotherapy administration should be evaluated.


The digital transformation in health care has been accelerated by the COVID-19 pandemic. Video consultation has become the alternative for hospital consultation. It remains unknown how to select patients suitable for video consultation.This study aimed to develop a tool based on patient-reported outcomes (PROs) to triage total hip arthroplasty (THA) patients to hospital or video consultation.A pilot study with expert panels and a retrospective cohort with prospectively collected data from 1228 THA patients was executed. The primary outcome was a PRO triage tool to allocate THA patients to hospital or video consultation 6 weeks postoperatively. Expert panels defined the criteria and selected the patient-reported outcome measure (PROM) questions including thresholds. Data were divided into training and test cohorts. Distribution, floor effect, correlation, responsiveness, PRO patient journey, and homogeneity of the selected questions were investigated in the training cohort. The test cohort was used to provide an unbiased evaluation of the final triage tool.P=.19).The expert panels selected moderate or severe pain and using 2 crutches as the triage tool criteria. PROM questions included in the final triage tool were numeric rating scale (NRS) pain during activity, 3-level version of the EuroQol 5 dimensions (EQ-5D-3L) questions 1 and 4, and Oxford Hip Score (OHS) questions 6, 8, and 12. Of the training cohort, 201  patients needed a hospital consultation, which was statistically equal to the 150  patients in the test cohort who needed a hospital consultation (A PRO triage tool based on moderate or severe pain and using 2 crutches was developed. Around 70% of THA patients could safely have a video consultation, and 30% needed a hospital consultation 6 weeks postoperatively. This tool is promising for selecting patients for video consultation while using an existing PROM infrastructure. The digital transformation in health care has been accelerated by the COVID-19 pandemic. Health care institutions are challenged by precautionary measures to contain COVID-19 while continuing to provide health care. Especially, managing the physical flow of patients is challenging. After the pandemic, hospitals will begin to eliminate their waiting lists while maintaining a normal patient flow, and they will be challenged again. As a solution, video consultation has become an alternative to the traditional hospital consultation. The number of hospital consultations has dropped by 30%, and the number of telemedicine visits has increased 5-fold ) . PROs wePain at rest and pain during activity were both measured using an NRS question scored from 0 (no pain) to 10 (severe pain). Quality of life was assessed using the EQ-5D-3L questionnaire consisting of 2 parts: EQ visual analogue scale  and EQ-5D descriptive system existing of 5 questions about 5 dimensions. These 5 dimensions are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, scored from 1 (no problems) to 3 (extreme problems) . Furtherr≥.7) with another selected question(s) [P>.05) [Regarding the investigation of the clinimetric qualities of selected questions or triage criteria groups by the expert panels, the cohort was divided into 2 groups: training cohort of patients who underwent surgery in 2016 or 2017 and a test cohort of patients who underwent surgery in 2018. To assess which questions were appropriate for the triage tool, the following clinimetric qualities were investigated per selected question in the training cohort: distribution, floor effect, correlation, responsiveness, and PRO patient journey. PRO patient journey was defined as a change in recovery over time. Regarding distribution, if the question did not show any distinction (median and IQR on the same level), the question was found not to be an appropriate question for the triage tool. For floor effect, if more than 15% of the patients scored the worst score [stion(s) , this qu [P>.05) , it did  [P>.05) , this quThe final triage tool was applied in the test cohort to provide an unbiased evaluation of the final tool fitted on the training dataset. Results in both cohorts were compared to investigate the hypothesis.t tests or Mann-Whitney U tests for continuous variables were executed depending on the distribution of the data, and Pearson chi-square or Fisher exact tests were executed for categorical variables.Results are reported as mean (SD), median (IQR), or n (%) based on the test performed. To investigate if there was any difference in patient characteristics, response rates, and preoperative PROs between the training and test cohorts, continuous variables were first checked for a normal distribution. Second, independent Distribution was investigated with a boxplot distribution, floor effect was determined by calculating the percentage of patients with a minimum score, and correlation was assessed with Spearman correlation analyses. Responsiveness was evaluated by performing Wilcoxon signed rank tests on the change in preoperative and 3-month scores ,21. The Finally, the triage tool was applied for both training and test cohorts. To test the hypothesis, the numbers of hospital and video consultations for both cohorts were compared using Pearson chi-square or Fisher exact tests.An α of .05 was considered statistically significant. Statistical analyses were performed using SPSS version 25.0 .“Having moderate or severe pain” and “using 2 crutches” were defined as the triage criteria by the clinical expert panel (step 1). For the criterion of “having moderate or severe pain,” the research expert panel selected the following PROM questions: NRS pain at rest, NRS pain during activities, EQ-5D-3L question 4, and OHS questions 1, 8, 10, and 12. For both NRS pain questions, previous studies reported thresholds of ≤3 for no or mild pain and >3 for moderate to severe pain ,23. For P=.99) and at 3 months  and 12 months  postoperatively. The training cohort consisted of significantly fewer patients than in the test cohort with an ASA I score , lower Charnely scores (P=.048), higher preoperative HOOS-PS scores , and lower preoperative OHS scores  and test (n=482) cohorts preoperatively . Regarding correlations ≥0.7, NRS pain during activity correlated with NRS pain at rest  and OHS question 1 .The final triage tool resulted in 201  patients in the training cohort needing a hospital consultation, which was statistically equal to the 150  patients in the test cohort who needed a hospital consultation , by developing the triage tool, they desired to see all patients who potentially needed a physical examination or other examination, such as an X-ray, during a hospital consultation. Furthermore, they desired to prevent obtaining more consultations by needing to schedule a hospital consultation after a video consultation. Both implicitly resulted in more liberal criteria for a hospital consultation leading to more patients triaged to a hospital consultation. Second, it could be that specific questions are missing from the triage tool. It was hypothesized that, after an investigation of the triage tool in daily practice, the criteria for the triage tool could be improved, achieving the right health care for each patient and a further reduction in hospital consultations. It would be interesting to investigate how many additional hospital consultations would be needed if the tool triages to video consultation and which PROs are different for patients with an additional hospital consultation.It is essential to understand that the PRO triage tool is not a tool on its own, but it is the first step in the selection of patients who need a hospital consultation and those who can have a video consultation instead. PROs and clinical judgment produce complementary data and when combined, provide a more accurate description of the patients’ symptoms . TherefoPrevious studies reported that patients rate their video consultations as excellent or very good (92%-95%) ,26. The As a first strength of this study, to the authors’ knowledge, this is the first study in which a tool to triage patients to hospital or video consultation was developed. Second, high response rates preoperatively and even postoperatively (above 90%) were achieved, resulting in a representative cohort to execute this study and to generalize the results to the total THA population. A third strength is the application of the training and test cohorts to provide an unbiased evaluation of the final tool.As a limitation of this study, the triage tool was not investigated in a prospective cohort, and aspects of reliability, validity, sensitivity, and specificity of the triage tool were not investigated yet. Furthermore, 3-month PROs were used instead of 6-week PROs, as, although based on previous studies, the assumption was made that there is limited clinically relevant difference between PROs at 6 weeks and at 3 months postoperatively ,12. FutuIn conclusion, a THA PRO triage tool based on moderate or severe pain and using 2 crutches was developed. Around 70% of THA patients could safely have a video consultation, and 30% of patients needed a hospital consultation 6 weeks postoperatively. This tool is promising for selecting patients for video consultation while using an existing PROM infrastructure.


Introduction: The management of musculoskeletal disorders is complex and requires a multidisciplinary approach. Manual therapies, such as spinal manipulative therapy (SMT), are often recommended as an adjunct treatment and appear to have demonstrable effects on pain and short-term disability in several spinal conditions. However, no definitive mechanism that can explain these effects has been identified. Identifying relevant prognostic factors is therefore recommended for people with back pain.Objective: The main purpose of this study was to identify short-term candidate prognostic factors for clinically significant responses in pain, disability and global perceived change (GPC) following a spinal manipulation treatment in patients with non-specific thoracic back pain.Methods: Patients seeking care for thoracic spine pain were invited to participate in the study. Pain levels were recorded at baseline, post-intervention, and 1 week after a single session of SMT. Disability levels were collected at baseline and at 1-week follow-up. GPC was collected post-intervention and at 1-week follow-up. Biomechanical parameters of SMT, expectations for improvement in pain and disability, kinesiophobia, anxiety levels as well as perceived comfort of spinal manipulative therapy were assessed.Analysis: Differences in baseline characteristics were compared between patients categorized as responders or non-responders based on their pain level, disability level, and GPC at each measurement time point. Binary logistic regression was calculated if the statistical significance level of group comparisons (responder vs. non-responders) was equal to, or <0.2 for candidate prognostic factors.Results: 107 patients  were recruited. Mean peak force averaged 450.8 N with a mean thrust duration of 134.9 ms. Post-intervention, comfort was associated with pain responder status (p < 0.05) and GPC responder status (p < 0.05), while expectation of disability improvement was associated with GPC responder status (p < 0.05). At follow-up, comfort and expectation of pain improvement were associated with responder GPC status (p < 0.05). No association was found between responder pain, disability or GPC status and biomechanical parameters of SMT at any time point.Discussion: No specific dosage of SMT was associated with short-term clinical responses to treatment. However, expectations of improvement and patient comfort during SMT were associated with a positive response to treatment. Musculoskeletal disorders (MSD) represent a growing public health issue for societies, with an ~30% increase in MSD-related disability observed globally since 1990 . Of all Although there are far fewer studies investigating the nature and treatment options for thoracic spine pain than for low back and cervical pain, spinal pain seems to have similar characteristics across the cervical, thoracic and lumbar regions , 4. In fThe management of spinal disorders is complex and requires a multidisciplinary approach as recommended by recent guidelines , 9. As aManual therapies, such as spinal manipulation therapy (SMT), are recommended and appear to have demonstrable effects on spine pain intensity and short-term disability , 12, 13.From a biomechanical standpoint, SMT is defined as a thrust of high velocity and low amplitude delivered to the spine using a specific contact . It can Dosage-focused studies usually investigate the effect of a treatment on a specific condition, but we are unaware of any studies assessing the association between dosages and responders to a single SMT treatment where responders to a treatment are determined by a minimal improvement change (MIC) in pain intensity and disability. MIC is the patient's perception of the smallest change on a patient-reported outcome measure considered to be a clinically important improvement .The primary aim of the study was to explore and identify short-term candidate prognostic factors for clinically significant responses in pain, disability and global perceived change (GPC) following a spinal manipulation treatment in patients with non-specific thoracic back pain. The study was designed to identify SMT dosages-related factors associated with positive treatment responses and identify “patient profiles” of responders to spinal manipulation treatments.clinicaltrials.gov (NCT04388007) and was approved by the ethics committee of the Université du Québec à Trois-Rivières (CER-20-265-10.02), as well as by the French Committees of Protection of Persons (19.04.27.61617-2019_45). Written and oral informed consent were obtained for all patients. Patients were recruited at chiropractic clinics of the Institut Franco-Européen de Chiropraxie (IFEC) from February 2020 to June 2021.This is a 7-day single group prospective cohort study including 107 patients. As described in the PROGRESS series and in a framework proposed for prognostic research , this waTo be included, patients had to fulfill the following criteria: age over 18 years old; non-specific thoracic spine pain intensity (chronic ≥ 3 months or recurrent complaint with an NRS pain score ≥3) and speak French or English. Eligibility criteria were assessed verbally in order to establish patients' eligibility to the study , 23. ExcPatients seeking care for thoracic spine pain and meeting eligibility criteria were invited to participate in the study. They received questionnaires in consecutively numbered sealed opaque envelopes. At baseline, the following variables were collected: thoracic spine pain intensity, thoracic spine-related functional disability, kinesiophobia, anxiety, as well as expectations for improvement . Details of the measurement timeline for the variables are presented in During each treatment session, patients received a single SMT treatment for their thoracic spine pain, delivered by a final-year student in the chiropractic program. Thoracic SMT, using high velocity and low amplitude procedures, was applied between T1 and T12 owing to the patient's symptoms. The spinal segment to be manipulated was determined following a complete clinical examination and palpation of the painful area, and as agreed upon between the attending student and their clinical instructor. All SMT were performed using a posterior to anterior force application vector. SMT biomechanical parameters were recorded during the intervention using a Leander 900 Z Series treatment table  with an embedded AMTI force plate . This device can estimate the loads transmitted during the high-velocity, low-amplitude (HVLA) manipulation and has shown reliability as well as validity in measuring force parameters . All traPatients' characteristics such as sex, height, weight, age, and level of education were assessed at baseline.SMT dosages were assessed using the following biomechanical parameters of spinal manipulation: peak force (N), preload force (N), force (N), thrust duration (ms), as well as rate of force application (N/s). Expectations for improvement in pain and disability, respectively, were assessed at baseline and reported via a modified version of the Patient Global Impression of Change scale. Patients answered the following questions: “On a scale of −5 to 5, how would you rate your expectations of improvement in pain/disability?”. For each construct, expectations were rated on an 11-point numeric rating scale, with 0 representing no change of pain or disability, −5 representing a deterioration of pain or disability, and +5 representing an improvement of pain or disability –27. KineThe measurement time points for each clinical outcome measure are presented in Disability was assessed using the Quebec Back Pain Disability Scale (QBPS) . This quThe global perceived change (GPC) was assessed post-intervention immediately following SMT and at 1-week follow-up using the following question: “How is your thoracic pain now, compared to before you entered this study?” using an 11-point score scale. A higher score meant that the pain had improved, and a lower score meant that the pain had worsened. Kamper et al. states that for an 11-point scale for GPC, any change >1.35 points is considered clinically important, and every change of 2 points or more is considered a clinically meaningful change .T-test or Wilcoxon rank-sum test for continuous variables (according to data distribution).The patients' baseline characteristics, spinal manipulation biomechanical parameters and clinical outcomes were calculated and presented as means and SD for continuous variables when normally distributed. Median and interquartile range were used for non-normally distributed data whereas proportions were used for categorical variables. The number and proportion of patients reporting clinically significant improvement in, respectively, (1) pain intensity (post-intervention and follow-up), (2) GPC (post-intervention and follow-up), and (3) disability level (follow-up) were calculated. Comparisons between patients who completed the study at follow-up and those who did not were performed using t-test or the Wilcoxon rank-sum test for continuous variables (according to data distribution), whereas the chi-square test was used for categorical variables. To assess the strength of association with responders' status, candidate prognostic factors were included in a binary logistic regression if the group comparisons (responders vs. non-responders) level of statistical significance was equal to, or <0.2. Strength of associations were reported as odds ratios (OR), 95% confidence intervals, p-value and r2. An alpha level of 0.05 was used to determine statistical significance. This is an exploratory study where every variable was considered as a candidate prognostic factor and accordingly, no confounder was pre-established  with a mean age of 32.3 years were included after meeting the pre-assessment criteria that included scoring 3 or more on the NRS pain scale . As twenty-three patients did not properly complete the NRS pain score at baseline assessment, their baseline pain intensity values were therefore excluded from the pain responders' model. At baseline, mean pain intensity and disability level averaged 4.89 (±1.7) and 15.6 (±13.6), respectively. Among all patients, 97 completed the follow-up assessments (response rate = 89%). Tests results for independent variables showed no significant differences between patients who completed the follow-up questionnaires and those who did not for baseline characteristics . Height,Out of 107 thoracic SMT provided by chiropractic students in their final year of clinical training, 106 were recorded. Data from one SMT was not available due to technical difficulties during data collection. Mean peak force averaged 450.8 N (SD ± 156.3), with a mean time-to-peak of 134.9 ms (±41.9). SMT force-time profile characteristics are presented in Mean pain intensity at baseline, at post-intervention, and at follow-up averaged respectively 4.9 (±1.7), 3.2 (±2.3), and 2.6 (±2.2). A decrease of −1.1 (±2.05) and −1.9 (±2.3) of the mean pain intensity change was observed at post-intervention and at follow-up. Means of each outcome measured at baseline, post-intervention and follow-up are presented in T-test or Wilcoxon rank sum tests for all independent variables and pain responder status are presented in p < 0.001). At follow-up, results showed differences between responders for expectation of disability improvement (p = 0.036). The strength of these associations was assessed using univariate models of candidate prognostic factors associated with pain responder status at post intervention and follow-up are presented in p = 0.017, r2 = 0.1282). Expectation of disability improvement was associated with pain responder status at follow-up . Pain change at post-intervention was associated with pain responder status at follow-up .Thirty-one patients (37.8%) were classified as responders based on pain improvement after the procedure, and 49 patients (66.2%) at follow-up . Resultsp > 0.05). Baseline characteristics of the disability responder status at follow-up are presented in Of the 94 patients with complete data, 41 (43.6%) were classified as responders, based on improvement of their disability level at follow-up , where nT-test or Wilcoxon rank sum tests for all independent variables and GPC responder status are presented in p = 0.022) and comfort of SMT (p < 0.001). At follow-up, results showed differences between responders for expectation for improvement in pain (p = 0.005), in disability (p = 0.017), comfort of SMT (p = 0.006), as well as GPC at post-intervention (p < 0.001). The strength of these associations at post-intervention and follow-up are presented in p = 0.017, r2 = 0.0446), as well as at follow-up . Comfort of SMT was associated with GPC responder status at post-intervention  as well as at follow-up . Expectation of pain improvement was associated with GPC responder status at follow-up . GPC at post-intervention was also associated with GPC at follow-up .Of the 105 patients with complete data, 68 (64.7%) were classified as responders, based on their improvement of global perceived change at post-intervention and out of 94, 68 patients (72.3%) at follow-up . ResultsNo association was found between pain, disability or GPC responder status and biomechanical parameters of SMT.Out of the 107 patients, seventy (65.4%) presented complete data. For pain responder status, 28 patients responded to treatment at post-intervention with a total of 23 still responders at follow-up. For disability responder status, 32 patients were responders to treatment at follow-up. For GPC responder status, 46 patients were responders at post-intervention with 37 still responders at follow-up. Details of responders' status are presented in n = 10) or muscle aches (n = 3).SMS tracking was used to assess side effects for 6 days after the intervention. At day 1, there was a response rate of 84.1% of the 107 patients, with a mean pain of 3.15 (±1.97). At day 6, we observed a response rate of 46.7%, with only 50 patients who kept answering the SMS. Mean pain at day 6 averaged 2.82 (±2.2). Response rates for adverse events averaged 12.1%, with only 13 patients reporting adverse events, such as pain increase  on patients experiencing chronic neck pain . The resAlthough our study failed to identify a SMT dosage associated with short-term clinical outcome improvement, this is the first study to investigate how SMT biomechanical parameters and related comfort are associated with short-term clinical outcomes. Results show that patients' perceived comfort of SMT is associated with an improvement in pain immediately following the intervention and with a global perceived change immediately after the intervention and at follow-up. Our results indicate that patients who rated a higher score for comfort of SMT were more likely to have a decrease of pain and to experience a global change of their symptoms during this 1-week post-procedure. Through a Delphi process, O'Donnell et al. investigated what educators and clinicians considered to be important characteristics of the patients and clinicians' positions before and during SMT. Results showed that patient comfort was identified as important, with a high level of agreement . In addiComfort is a concept that has been studied in different environments , and for which investigators have developed guidelines and consensus statements to enhance patients' experience –44. For Results of the present study show that patients were more likely to have a meaningful decrease in pain intensity when expectation of disability improvement was greater at baseline. In addition, a meaningful GPC at follow-up was associated with greater expectation scores for improvement in pain and disability.Expectations have been studied recently in the context of SMT. Indeed, Pagé et al. investigated the effect of SMT on outcomes in patients with chronic thoracic pain . ExploraCormier et al. explored the association between expectations and clinical outcomes of patients with chronic pain. The authors showed that there is an association between expectations and clinical outcomes following a multidisciplinary treatment approach for chronic pain. Their results showed that pain responder status was associated with greater pretreatment expectations and higher global perception of change after care . A systeAlthough patients' characteristics were assessed in this study, none were linked to clinical responses. Anthropometric criteria such as height, weight or BMI do not influence treatment response. Moreover, the influence of anthropometric characteristics on biomechanics parameters has been previously investigated. Mikhail et al.  investigp = 0.027). Global responders (n = 20) at follow-up had higher expectation for pain improvement and disability, higher GPC score post-intervention and lesser pain at post-intervention compared to non-responders (n = 9).While patients' characteristics were not correlated with any outcome in the model, 20 patients were full responders at the follow-up . These 20 patients included 11 women (mean age = 32.9 ± 15.4) and 9 men (mean age = 29.9 ± 9.8) with women presenting significantly higher level of disability at baseline  and French Committees of Protection of Persons (19.04.27.61617-2019_45). The patients/participants provided their written informed consent to participate in this study.MP: conception and design of the study's, data collection, data analysis and interpretation, drafting the article, and final approval of the version to be published. JY: data analysis, critical revision of the article, and final approval of the version to be published. AL: conception and design of the study's, data analysis and interpretation, critical revision of the article, and final approval of the version to be published. MD: conception and design of the study's, critical revision of the article, and final approval of the version to be published. All authors contributed to the article and approved the submitted version.MP received a scholarship from the Fondation Chiropratique du Québec for a doctoral thesis.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer PT declared a shared consortium with one of the authors MD at time of review.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.