Pain intensity may be varied during the needle advancing through different skin layers, injection into the intradermal layer may exclude mixed pain from deeper planes. This study aimed to investigate whether compressing a three-dimensional (3D)-printed disk against the skin may relieve pain associated with intradermal injection of local anesthetic which mimics the skin test procedure.After institutional review board approval, 3D-printed disks with projections were designed for this study. Enrolled patients were randomized to receive either a disk compressing against the axillary skin during the intradermal injection of local anesthesia (compressing disk group) or an intradermal injection of local anesthesia without any compression (no compressing disk group). The primary outcomes were pain intensity  and satisfaction  as assessed by patients.P < 0.001) in compressing disk  and no compressing disk  groups. The median satisfaction score was 5 in both groups. No complications occurred during follow-up.Ninety patients with American Society of Anesthesiologists I–II physical status receiving intradermal local anesthesia prior to an ultrasound-guided axillary approach were included. Eighty-seven patients completed the study, with 44 and 43 patients in disk and no disk groups, respectively. Pain scores were significantly different (Compressing a 3D-printed disk against the skin may reduce intradermal needle pain and offers an effective alternative for nerve block induction.The online version contains supplementary material available at 10.1186/s12871-023-02088-y. In the setting of brachial plexus block for elective surgery, anesthetizing the local tissues is common for reducing this kind of pain intensity during the needle insertion process . ParadoxTo the best of our knowledge, there are no published studies on the use of ShotBlocker® for intradermal needle insertion and injection pain relief. This study aimed to clarify whether a compressing device with projections may reduce the pain intensity associated with intradermal insertion and injection without advancing into deeper layers. However, this common device is still not available in China; therefore, we designed a three-dimensional (3D)-printed U-shaped ultraviolet (UV)-curable resin disk to confirm this hypothesis.This prospective randomized controlled study was approved by the ethics committee of our hospital on February 28, 2022  and was registered in the Chinese Clinical Trial Registry  before the first patient enrollment. All patients were informed of the purpose of the study and consented to participate. A flowchart was used for patient enrollment and allocation under the Consolidated Standards of Reporting Trials (CONSORT) guidelines.The patient inclusion criteria were 1) age ≥ 16 years Asian, 2) undergoing orthopedic surgery distal to the elbow, 3) American Society of Anesthesiologists (ASA) I–II physical status, 4) hospitalized patients who receiving intradermal injection of local anesthesia  prior to the ultrasound-guided axillary approach to brachial plexus block. The exclusion criteria were 1) emergency surgery, 2) analgesic medication within 6 h prior to injection, 3) anxiolytics or antidepressants medication status, impaired or unstable coagulation situation, 4) infection, 5) pre-existing skin pain at the site of needle insertion or of the involved limb, 6) allergic to local anesthesia, and 7) poor cooperation or verbal communication. Before the injection procedures, all patients were instructed to rate needle injection anxiety scores using a 5-point Likert scale , rangingwww.randomizer.org) to generate two sets of 45 numbers with values of 1 or 2, each of two independent observers (WXC and QYL) received a certain set according to coin flip and sequentially enrolled patients according to the respective random number order. Number 1 represented the compressing disk group, n = 45, in which the 3D-printed disk with projections was compressed against the axillary skin during local anesthetic induction; number 2 represented the control (no compressing disk group), n = 45, which received regular intradermal injection of local anesthetic without any compressing devices.Using a Research Randomizer (0), 1 mm; height, 5 mm; and disk thickness, 1.5 mm. The projection curve data were as follows: outer projection curve radius (R1), 27 mm; middle projection curve radius (R2), 18 mm; and inner projection curve radius (R3), 9 mm. The interval between the two projections in the same curve, distance between arcs, side arm length, and lateral wing length were 3.5 mm, 5.8 mm, 45 mm, and 25 mm, respectively. The curve angle at the bottom was 83°. Regarding shape data, eight arcs were designed on the disk at the outer corners and fenestration bottom with radii of 30 mm (R4), 10 mm (R5), 20 mm (R6), 5 mm (R7), and 5 mm (R8). Their appearances are shown in Fig. We used 3-matic  to compress the disks according to the design  of ShotBlocker®. The disks were printed using UV-curable resins into a smooth U shape with projections on one side. The detailed design parameters were as follows: radius for each projection cylinder , without any analgesic or sedative medications. Sterile preparation was applied to the anesthesia site of the axilla, followed by a systematic ultrasound scan  to determine the optimal location for nerve block placement, and a point was marked for needle insertion. Each patient was instructed to keep the eyes shut and turn the head to the contralateral side during intradermal injection of local anesthesia prior to the nerve block. All anesthetic procedures were trained and conducted by three attending anesthetists. For the intervention group, the compressing disk was applied with projections against the axillary skin centered at the marked point  , 12 and . Considering a 20% dropout rate, we finally allocated 90 patients, with 45 patients in each group. The Statistical Package for the Social Sciences (SPSS) version 26  was used for statistical analyses. Results are described as mean (standard deviation), median value (IQR), or proportion, as specified. The median (interquartile range [IQR]) pain scores and number (proportion) of patients with pain scores > 30 mm as moderate pain were calculated [2 test. Statistical significance was set at P < 0.05. To compare the distributions and density curves between the two groups, boxplot and violin plots were generated using http://www.bioinformatics.com.cn, a free online platform for data analysis and visualization.The sample size was calculated using PASS . With a significance level  of 0.05, using a one-sided two-sample unequal-variance t-test, group sample sizes of 36 and 36 achieved 99% power to reject the null hypothesis when the means of the compressing and no compressing disk groups were 27.91 and 18.85, respectively, with standard deviations of 10.54 and 8.45, respectivelylculated . ParametP > 0.05). The median pain severity in the intervention group (red violin plot) was 10 mm , which was significantly lower than that in the control group (green violin plot), whose median pain score was 30 , as shown in Fig. P < 0.001). The VAS scores > 30 mm were 0.068 (3/44) and 0.605 (26/43) in the compressing and no compressing disk groups (P < 0.001), respectively, a statistically significant difference. Observed, from the boxplot and violin plot, VAS pain scores are distributed more concentrated near the median value in the compressing disk group than no compressing group. The pain scores between the two groups were significantly different in both anxiety subgroups (P < 0.001). The median usability of the compressing disk was 1 point, indicating easy use in the procedure. All patients were observed and followed up at 8 h without unexpected events or any axillary site complications.There were 44 patients randomized to the compressing disk group, 43 in no compressing disk group with mean age of 44 ± 13 and 46 ± 13 years old respectively. Sixty men and twenty-seven women were included in this study. BMI and ASA classification distributions were comparable between the two groups with no data significant , a uniform 3-mL lidocaine volume, and unregulated injection speed (because it has no effect on pain scores according to the study) . The irrConsidering the heterogeneity of pain sensation, especially injection anxiety, which may affect pain scores and satisfaction , 25, it It was demonstrated that stressor (e.g. needle pain) can induce difference in vital signs by stimulating the sympathetic nervous system . In addiThe skin wheal for local anesthesia in spinal block has recently been considered a controversial topic ; howeverAs strengths, the present study used randomization and uniform application sites, insertion layer, needle gauge, and patient conditions to investigate whether a compression disk with projections may reduce pain intensity during intradermal infiltration anesthesia. Our results supported compression disk use.This study has certain limitations. The study was conducted at a single center with a relatively small patient sample. Furthermore, a placebo group was not included because former related studies had designated the flat side of the disk as a placebo intervention , 13; howIn conclusion, this prospective randomized study showed that a 3D-printed UV-curable resin-compressing disk may relieve needle insertion and injection pain for axillary intradermal needle puncture during intradermal lidocaine injection. This is a safe, convenient, and effective physical analgesic method prior to nerve block anesthesia.Additional file 1.Additional file 2.Additional file 3.


VR experience intervention consisted of using a headset with a smartphone adapted to a virtual reality glasses where an app-video was played during the procedure. Main outcomes analyzed were pain, discomfort, heart rate variability, difficulty and duration of the cystoscopy. Statistical analyses were performed using a Student’s t test, Mann-Whitney test and Chi-square test. A P<0.05 was considered to be statistically significant.  among 159 patients studied , the mean age was 63,6 years and 107  were male. There was no statistically significant difference in baseline characteristics between the 2 groups. VR was significantly associated to decreased heart rate variability  and lower duration of the procedure . Also, when cystoscopies due to double-J extraction were excluded, VR experience was associated with reduced pain on the visual analog score of pain .  the use of VR as a distraction therapy while performing outpatient cystoscopies is safe, has no side effects, is associated with less pain and discomfort, and reduces length of procedure.  It consists of an insertion of a tube (flexible or rigid) equipped with a lens and light called cystoscope through the urethra that allows visualization of the lower urinary tract. Cystoscopy might be performed in an urology office or a hospital under sedation or local anesthesia. In the Brazilian public health system about 2500 cystoscopies are performed monthly, most of then on an outpatient basis and under local anesthesia-Pain is a sensation that alerts the organism about potentially damaging stimuli. The human mind has a limited capacity and must be aware of pain in order to perceive itVirtual Reality (VR) is a type of cognitive distraction that creates a visual and auditory immersion, lowering the noise and connection with the external environment-Though VR is a technique still unknown by several medical doctors, it has been successfully used to minimize procedural pain in various situations as changing burn dressings, venipuncture, dental procedures, lipoma resections and minor surgeriesBased on the hypothesis that the use of distractions might reduce discomfort and anxiety during medical procedures, we sought to analyze whether the use of VR during rigid cystoscopy is correlated to decreased pain when compared to patients not using this technology.We performed a prospective randomized clinical trial that included patients who underwent elective rigid cystoscopy under local anesthesia between April 2019 to September 2019. Were excluded from the study patients younger than 18 years old, with cognitive or sensorial limitations (such as dementia or blind patients), and patients who refused to participate, or who underwent an aggregate procedure . The cystoscopies were subdivided according to their indications: diagnostic ; follow-up (after or during non-muscle-invasive bladder cancer therapy); or for double-J stent extraction.The sample size was calculated based on an alpha error of 5% and a beta error of 20% (with a power of the study of 80%), with an average pain of 4,4  and a standard deviation of 214. The study was designed to detect a 20% difference between groups. Thus, the calculated sample was 156 patients (78 in each group).A Visual Analog Scale (VAS) was applied to each patient to assess pain and anxiety status . DifferePatients were randomized into two groups (VR experience and control). To avoid sample contamination, given that patients stayed in the same waiting room previous the procedures, randomization in blocks was performed (per day): every day, alternately, all scheduled patients were included in the control or the intervention group.Cystoscopy with a rigid cystoscope was performed two minutes after intraurethral injection of 20ml of 2% lidocaine gel. The procedure was executed by one of a team of three medical residents in Urology. Decision to perform bladder biopsy was assessed during the procedure. As an objective parameter of pain, heart rate (HR) was monitored during cystoscopy and registered as variation over the basal HR on the peak. The duration of procedure was timed at the moment the cystoscope was introduced into the urethra and ended with its removal.® A5 mobile phone adapted to Trust Urban® Exos 3D virtual reality glasses and a headset. The patient placed the glasses on his face and positioned himself for the cystoscopy. On the screen, an app-video was playing simulating a ride on rails , discomfort , heart rate variation (on bpm), difficulty , and duration (on minutes). Difference among scale rates were measured in centimeters (cm).Baseline characteristics studied were gender , age (years), BMI (kg/m²), smoking (yes/no), ethnicity (white/black/others), number of previous cystoscopies, co-morbidities, cystoscope sheet (number 17/19/20), bladder biopsy (yes/no) .Quantitative variables were analyzed using Student’s t-test for variables with normal distribution and Mann-Whitney for non-normal distribution. Categorical variables were analyzed using Chi-square test. The level of statistical significance was considered as p<0.05.The study was approved by the IRB of Hospital Nossa Senhora da Conceição, under the CAAE number 08503119.9.0000.5530, and the clinical trial was registered on the Brazilian Clinical Trials Registry (ReBEC) under the Universal Trial Number (UTN) U1111-1235-8825. All patients consented for the study.A total of 175 cystoscopies were performed. Sixteen patients were excluded from the study due to: aggregate procedure (n=4), dementia (n=3), stent calcification (n=2), a blind patient (n=1), cystoscope malfunction (n=1), under age patients (n=2), presence of orthotopic bladder (n=1) and refuse of the patient (n=2). Among 159 patients enrolled, 80 patients were randomized to VR group and 79 patients to control group. There was no significant difference between the groups regarding age, BMI, pre-procedure anxiety, pre-procedure heart rate, gender, ethnicity, number of previous procedures, biopsy and type of procedure . VR use was significantly associated to lower heart rate  and duration of the procedure  . SurgeonWhen double-J extraction  was removed from the sample, VR group described lower pain when compared to controls with significance (p=0.023) . None of,-Although several patients undergoing cystoscopy frequently complain about pain and discomfort during the procedure, there are several forms of distraction such as using a second screen for the patient, music, stress ball, or oral explanation to reduce painThe VR has been studied to alleviate pain and anxiety during diverse medical procedures. Hua et al. analyzed the use of VR as a non-pharmacologic intervention on a prospective randomized trial of 65 pediatric patients with chronic wounds on lower limbs who required active dressing changes. They demonstrated that patients who experienced VR showed significant lower pain on VAS scales and lower length of procedureSome studies have reported the use of distraction techniques during cystoscopies to alleviate pain with mixed results. For example, Gupta et al. found that patients listening to music and with real-time visualization of the procedures during cystoscopies reported significantly lower pain when compared to controls. The authors also showed that in the intervention group post-procedural pulse rate was diminished in comparison to pre-cystoscopy (p<0.001)The relationship of non-pharmacological distraction therapies and pain reduction throughout medical procedures is an interesting question still under investigation. It has been acknowledged that pain perception is closely related to mind attentionThe pain can be modulated by cognitive factors, like attention and distraction. Generally, the attention has to be actively directed to non-painful stimuli to avoid that painful stimuli prevail. Also, other painful stimulus can reduce de pain of previous painful stimuliWe found that VR during cystoscopy is associated with lower pain in subgroup analysis, reduced length of procedure, diminished heart rate variability and less difficulty to perform cystoscopy. The clinical implications of our findings are multiple. In our country most part of cystoscopies are outpatient basis procedures and VR implementation might be a routine because it is costless and with neglectable side effects. In addition, it might reduce the use of analgesics and narcotics during other medical interventions making it a not so an unpleasant experience. Furthermore, VR environment is a multiple distraction method and appears to be as effective as using multiple distraction approaches. Another important issue is that patient on VR seems to be less restless and more relaxed during the procedure, making it easier and faster for urologist to perform the cystoscopy. Consequently, these suggests that VR is an interesting intervention to be used in medicine.Our study has several strengths, as a randomized controlled trial with a sizable sample. However, there are some limitations. First, mean age of our patients is over 60s and most of them are not familiarized with VR technology. Second, cystoscopies for double-J extraction were not excluded, and although this might influence in lowered length of procedure it also correlated to lower pain perception because it is faster than other cystoscopies as demonstrated on subgroup analysis. Third, there are other VR immersion technologies with different softwares and hardwares that might be compared in intervention group, because previous experiences occasionally may influence in painful threshold. Relaxing videos on VR immersive and interactive environment are probably more effective to attenuate pain than action videos. Fourth, all procedures were performed by medical residents in Urology who were in training and under learning curve.Therefore, the use of VR as a distraction therapy was correlated with a reduction on the physiological response of pain (heart rate variability), as well as a lower distress during the cystoscopy, reducing the difficulty level and the time required to complete the procedure.Our study demonstrates that the use of VR as distraction therapy while performing outpatient cystoscopies is safe, has no side effects and reduces objective parameters of pain and discomfort, as well as facilitates the procedure and reduces its duration. The benefits of VR on reducing pain were significant in patients who underwent cystoscopy (excluding procedures for double-J extraction). However, given the fact that there are several new types of immersive technology of VR distraction, further studies are needed to analyze the feasibility of the method with more complex systems, as well as comparing it to other forms of distraction during the procedure.


Cluster headache (CH) is a trigeminal autonomic cephalalgia characterized by attacks of severe unilateral pain associated with ipsilateral autonomic symptoms. Cluster headache attacks exhibit nocturnal predilection, and sleep disorders could be the first manifestation of an incipient cluster period. Sleep alterations in cluster headache patients may reflect the pivotal role of the hypothalamus, which is crucially involved in the pathophysiology of this primary headache. We describe the case of a patient affected by episodic cluster headache who experienced a sleep disorder after starting therapy with verapamil.A 47-year-old man was affected by episodic cluster headache, characterized by attacks of excruciating pain in the left orbital and temporal regions, associated with prominent ipsilateral vegetative symptoms. Headaches occurred during the night, with one or two nocturnal attacks appearing at 11.30–12 p.m. and 4–4.30 a.m. Preventive treatment with verapamil was started, with immediate pain relief. Later, he experienced consecutive nocturnal awakenings for a couple of weeks, always at the same time, without any pain or autonomic symptoms. He was not agitated and did not need to get out of bed; after the awakenings, he reported sleep disturbances with vivid dreams.This case represents the first description of recurrent cyclic nocturnal awakenings, without pain and autonomic symptoms, in a patient with episodic cluster headache during the active phase of a cluster bout. Nocturnal awakenings, started after the introduction of effective preventive therapy, might be an unusual form of “ghost attacks.” After the beginning of prophylactic therapy, patients often describe mild pain or localized pressure in the same localization of CH attack. Similarly, the appearance of sleep disturbances, without any pain or vegetative symptoms, should be regarded as a warning sign of a still active cluster bout. Since these manifestations may influence therapeutic management, they should be carefully investigated. Cluster headache (CH) is a trigeminal autonomic cephalalgia characterized by attacks of excruciating unilateral pain, usually associated with prominent ipsilateral cranial autonomic symptoms . PainfulSince 2019, a 47-year-old man has been affected by episodic CH [according to the International Classification of Headache Disorders, ICHD-3 criteria .The patient was otherwise healthy. General and neurological examinations, routine blood tests, electroencephalogram, and brain magnetic resonance imaging, including arterial and venous magnetic resonance angiography, were normal.Regarding the sleep–wake habits, he did not complain of any sleep disorder and denied any need to take sleep medications in the past. This unusual phenomenon, characterized by a very regular pattern of presentation in the absence of a previous sleep disorder, has not been categorized as a specific sleep disorder.To the best of our knowledge, this case represents the first description of recurrent cyclic nocturnal awakenings without pain and autonomic symptoms that occur in a patient with episodic CH during the active phase of cluster bout. In the literature, sleep disorders have been reported as the warning sign of an incipient cluster episode  even if In the literature, descriptions of ghost attacks or clear evolution of headache symptoms after the introduction of prophylactic therapies are lacking. Only Meyer and Hardenberg reported that in four patients affected by chronic CH, the presence of “tightness” was noted around the affected eye (without pain development) during therapy with verapamil . This drCyclic nocturnal awakenings of our patient strengthen the importance of the hypothalamus in the pathophysiology of this primary headache. The orexinergic system seems to play a crucial role, both regulating sleep–wake cycle and modulating trigeminal nociceptive processing , but furOur case shows that nocturnal awakenings without any pain or vegetative symptoms may represent a sort of “ghost attack” in CH patients. In this light, sleep disturbances, similar to painful episodes, might be considered a manifestation of a still active cluster bout, thereby encountering the unmet needs of CH patients, as emerging from their blogs, potentially being a further element to evaluate the efficacy and duration of preventive therapy.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.Written informed consent was obtained from the patient for publication of this case report.GG and VD made the diagnosis. GG was responsible for case management and wrote the first draft of the manuscript. MG and MA contributed to completing the information related to the case. MG participated in the revision process. VD edited and approved the final version of the manuscript. All the authors read and approved the final manuscript.


BackgroundThe most exasperating aspect for pediatric patients in a dental setup is the fear and anxiety caused by injections, called "blenophobia". There are numerous local anesthetic agents available to reduce the needle prick pain. Taking into consideration the paradigm shift, there is always a possibility for alternate treatment options. This study aimed to evaluate and compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) application through an electronic acupuncture pen (Meridian Energy Acupuncture Pen W-912 GENERIC) and 2% lignocaine gel as an intraoral topical anesthetic agent in children.MethodPatients aged 6 to 12 years were eligible for inclusion. The topical anesthetic agents were administered to the patients in a bilateral split-mouth technique. In Group A, 2% topical anesthetic gel was administered on the first visit on one side of the mandible and topical anesthesia through the electronic acupuncture pen was administered on the next visit, on the opposite side of the mandible. The electronic acupuncture pen was applied on one side of the mandible on the first visit, and on the next appointment, 2% topical anesthetic gel on the other side was administered in Group B. Sound, eye, motor scale (SEM) and faces pain scale-Revised (FPS) were used as tools of evaluation after local anesthesia was administered. Results The comparison between electronic acupuncture pen and 2% lignocaine gel using the SEM scale shows a statistically insignificant difference . Similarly, a comparison of FPS values between both groups indicates no significant difference . However, results show a reduced pain perception in both groups.ConclusionTopical anesthetic agents are commonly used to reduce needle prick pain in children. TENS through the electronic acupuncture pen, a revisited aid in scientific research, has proved its efficacy as a topical pain reduction measure during dental treatment. This device overcomes the shortcomings of the anesthetic gels and also nullifies the chances of overdosage, hypersensitivity, and disagreeable taste. Thus, this tool can be used in dental practice for the management of pain in children. Pain has been an unvarying tormentor of mankind since time immemorial. In the field of pediatric dentistry, the most stressful facet of treatment for a majority of children is the fear and anxiety sourced by the dental surroundings, predominantly to the injection referred to as "needle-phobia" or "blenophobia" . AlleviaTopical anesthetic agents are widely used in dentistry before administering any intraoral injection. It has been proven that topical anesthetic agents have an inherent role before injections to decrease the pricking pain sensation of the needle stick . To dateThe use of acupuncture dates back over three thousand years. It is a traditional Chinese medical technique and the world's third most common method for treating pain. There are various types of acupuncture techniques, out of which electro-acupuncture is one of the promising methods . The tecHowever, pain due to needle insertion persists. So, the application of transcutaneous electrical nerve stimulation (TENS) to control pain is being explored in dentistry. In TENS therapy, pulsed electrical current is generated by alternating or by the direct current which is carried across the intact skin/mucosal surfaces via electrodes to stimulate superficial nerves for localized pain relief .With the advent of these techniques, the electronic acupuncture pen has been devised. The electronic acupuncture pen is a non-invasive method for producing local analgesia, and thus, this study was planned to evaluate the effectiveness of electronic acupuncture pen and 2% lignocaine gel as an intraoral topical anesthetic agent in children.The study design and methodology were approved by the Institutional Ethical Committee, DMIMS(DU)/IEC/Aug 2019/8294. The sample size(N) was calculated using Epi Info for a bilateral split-mouth, cross-over study which was 86. However, 100 participants were taken to avoid dropouts.Inclusion and exclusion criteriaThe participants included in the study were those living in the Wardha district, who 1) were aged 6-12 years; 2) required bilateral mandibular local anesthesia as local infiltration; 3) were not exposed to any dental treatment procedure earlier; and 4) were rated grade 3 or 4 in Frankl's behavior scale. The patients who 1) exhibited any acute infections or systemic diseases; 2) were specially abled; 3) were allergic to local anesthesia; 4) had any neuromuscular disorders; and 5) had undergone any prior dental treatment were excluded.Study designThe procedure and associated discomforts or risks were fully explained to the accompanying guardian, and their written informed consent was obtained before beginning the procedure. The participants were divided randomly into Group A and Group B by the lottery method. The area for application of the local anesthetic agent was the buccal vestibule adjacent either to the mandibular first and second primary molar or premolars depending on the eruption of the teeth. Group A: The participants in Group A were administered 2% topical gel on the first visit whereas, on the second visit, topical anesthesia was administered using the electronic acupuncture pen. Group B: The participants in Group B were administered topical anesthesia using the electronic acupuncture pen and in the second appointment 2% Lignocaine gel was administered.The topical anesthetic agent (2% Lignocaine Hydrochloride Indocaine 2% gel INDKUS) was applied on the buccal vestibule adjacent either to the mandibular first and second primary molar or premolars using a cotton applicator tip. The tip was kept in contact with the mucosa for around two minutes Figures , 2. The electronic acupuncture pen (Meridian Energy Acupuncture Pen W-912 GENERIC) was adjusted at a setting of '3' as instructed by the manufacturer. It was then placed over the buccal mucosa of the region where local anesthesia was to be administered. The device was in contact with the buccal mucosa only. The control over the wireless pen was switched on which was indicated by the red light on it. While keeping it in contact with the buccal mucosa, small circular motions were made for two minutes in the same region Figures .After both the topical anesthetic agents were applied according to groups, local anesthesia was administered to the patients using a 26-gauge needle (Dispovan), which was inserted until bone contact was achieved and then the anesthetic agent was deposited slowly at a pace of 1 ml/minute. During needle penetration, the assessment was carried out using the Sound, Eye, Motor Scale (SEM) by two trained observers . The valStatistical analysisThe data was recorded and IBM SPSS Statistics for Windows, Version 24  was used for the analysis. p-value <0.05 was considered as the level of significance. The normality of continuous data was analyzed by using descriptive ANOVA. The independent sample t-test and paired sample t-test were used to check the mean differences.Table Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage . A childA systematic review and meta-analysis stated that 2% of lignocaine compounds were more effective than 20% benzocaine in decreasing pain . A compaThe major drawback of commercially available topical anesthetic gels is their inadequacy to provide bioadhesiveness to the oral mucosa due to which the targeted area may or may not receive the required amount of agent, making its effect insufficient. It has a disagreeable taste causing discomfort to the patient . Other aHistorically, Voll developed an electrical stimulation (ES) device for application on the acupoints and meridians, thus instituting a technique known as "electroacupuncture." TENS is one such electrical stimulation  which isIn the present study, we found that 2% lignocaine gel was less effective as compared to the electronic acupuncture pen as depicted in Tables The anesthetic effect of the electronic acupuncture pen is attributed to two key theories: The gate control theory of pain and the endogenous opioid theory. The gate control theory of pain initiated by Melzack and Wall put forth that substantia gelatinosa is a modulatory center for afferent patterns from peripheral fibers, controlling the gate system. Pain transmission occurs by small unmyelinated C fibers and their action maintains the gate open . When thThis diverse mechanism of action possibly explains the better results seen in the electronic acupuncture pen group. This is in support of research carried out by Meechan et al. recommending that using electrical stimulation lessens injection distress better during nerve block administration when compared to 2% lignocaine .Pain assessment is a very individualized and subjective occurrence. After the administration of local anesthesia, the Wong-Baker FPS was described to the children for a subjective pain assessment . HoweverThe use of an electronic acupuncture pen reduces anxiety when used on the acupoint. This non-invasive application does not cause any adverse reactions and is comparatively cost-effective. The electronic acupuncture pen can be employed to replace 2% lignocaine gel, as its use may give better results in pain alleviation during needle pricking. The application of this electronic acupuncture pen was only done in adherent mucosa for local infiltration. However, the study has limitations in assessing objective parameters like heart rate, oxygen saturation, blood pressure, etc. Such parameters would have been helpful in deriving the efficacy of the TENS in a better manner.Topical anesthetic agents are commonly used to reduce needle prick pain in children. TENS through electronic acupuncture pen, a revisited aid in scientific research has proved its efficacy as a topical pain reduction measure during dental treatment. This device overcomes the shortcomings of the anesthetic gels and also nullifies the chances of overdosage, hypersensitivity, and disagreeable taste. Thus, this tool can be used in dental practice for the management of pain in children.


Recurrent Aphthous Stomatitis (RAS) is one of the most common lesions of the oral mucosa. Herbal medicine can be used for the treatment of this disease. The present study aimed to compare the effects of topical application of Sage  and triamcinolone acetonide gels on RAS.This double-blind clinical study recruited sixty patients with minor aphthous ulcers. Half of the patients were treated with Salvizan gel, and the other half were treated with oral triamcinolone acetonide gel. The effect of Salvizan topical gel was evaluated and compared with that of oral triamcinolone acetonide gel. Factors such as Pain recovery time, wound healing time, and pain level was evaluated. Data were analyzed by SPSS version 22 using independent t-test, paired t-test, repeated measures ANOVA, and survival analysis, including Kaplan-Meier and Cox regression.p < 0.001). Moreover, the duration of wound healing was 3.3 days for Salvizan and 6 days for triamcinolone acetonide (p < 0.001). Patients’ satisfaction from factors such as taste and smell had no significant difference between the two groups.The mean duration of pain recovery was 1.5 days for Salvizan and 2.5 days for triamcinolone acetonide  on 17/03/2021. It was also registered in the Iranian Registry of Clinical Trials (IRCT20100202003251N7). Recurrent Aphthous Stomatitis (RAS) is a common oral mucosa disease characterized by single or multiple painful and recurrent ulcers confined to the oral cavity. Its prevalence in different populations has been reported to vary from 5 to 50%, with an average prevalence rate of 20% and higher occurrence in young women . The preThere are predisposing factors reported for this disease, such as psychological, hematological, genetic, traumatic, and allergic factors. Still, the etiology of the disease is unknown. So, there is no definitive cure for the disease , 7. WhilHerbal medicines have become prevalent among people because of several health benefits attributed to these natural and safe agents. Herbal medicines are also widely used in dentistry because of their unique properties, including antimicrobial, antifungal, anti-inflammatory, and antioxidant effects . Due to Salvia officinalis  is an aromatic plant often used for different purposes, especially as a traditional medicine for treating several infectious diseases . Sage coSalvizan gel is a pharmaceutical product made of Sage extract used to alleviate the inflammation of the oral mucosa. A study in 2021 compared the effects of Salvizan and triamcinolone acetonide gels on the duration and symptoms of oral lichenoid reactions. They reported that Salvizan gel significantly relieved the pain better than triamcinolone acetonide, which is promising for using Salvizan gel in treating oral lesions . Also, iDue to the antimicrobial, anti-inflammatory, antifungal, and analgesic effects of Sage, which is used in Salvizan gel, and the lack of evidence in the considered population, the present study aimed to evaluate the effect of Salvizan gel on minor oral aphthous ulcers in comparison to triamcinolone acetonide.This study was approved by the ethics committee of Isfahan University of Medical Sciences (IR.MUI.RESEARCH.REC.1399.834) on March 17th, 2021. All methods were performed in accordance with the relevant guidelines and regulations. It was a double-blind, randomized clinical trial conducted from May to June 2021. The study was also registered in the Iranian Registry of Clinical Trials (IRCT20100202003251N7) on 13/10/2021. Informed consent was obtained from patients involved in the study. The ethical guideline for this study was “General Ethical Guidance for Medical Research with Human Participants in the Islamic Republic of Iran.”This study was performed in the Dentistry school of the Medical University of Isfahan. Patients with confirmed RAS aged 18–50 were included in this study. Exclusion criteria were pregnant or lactating women, history of allergy to herbal products, history of a systemic disease, history of using anti-inflammatory or corticosteroids, presence of herpetiform and major aphthous ulcers, and presence of lesions for more than 48 h. With a standard deviation of 1.67, absolute precision of 1.2, an α of 0.95, and a β of 0.2, the sample size was calculated as 30 persons in each group. Accordingly, 60 eligible patients were recruited for the study, and after giving the necessary explanations about the study, informed consent was obtained from all patients before inclusion in the study. For the blindness of the study, a code (“A” or “B”) was assigned to each patient randomly to determine the patient’s drug. One of the codes belonged to triamcinolone acetonide , and the other belonged to Salvizan gel . Both are drugs introduced for the treatment of aphthous ulcers. Each patient was assigned to one group with a random process performed by a third person. This study had a parallel arm design. The drugs were randomly defined as “A” and “B”. Then 60 drug tubes were coded and divided into groups of A (n = 30) and B (n = 30) with an allocation ratio of 1:1. The relevant tube was given to each patient, with a covered tube, so the researchers were blind to the treatment of each group until the end of the study. The person who analyzed the results was also blind to the groups. At the end of the study, experiment and control groups were indicated using these codes.Patients were instructed on how to take the drug. Then they were asked to show the process to be sure they understood the instructions correctly. It was topically applied to aphthous ulcers three times a day using a swab as much as 1 cm, preferably after eating and mouth rinsing. After applying the drug, the patient was told not to consume any drinks or food for at least one hour and not to smoke. The patient consumed the drug until the pain was relieved and the ulcer healed completely. Anti-inflammatory and analgesic drugs should not be used simultaneously with this drug, either topically or systemically. Each patient was also given a card to record the pain score of the aphthous lesion. Patients were told to rate the pain and burning three times a day  for a week. For this purpose, Visual Analogue Scale (VAS) was used to determine the extent of the pain. With this method, the patient will rate the pain in a range of 0 to 10, depending on the amount of pain. On this scale, 0 indicates no pain, and 10 indicates maximum pain. Patients record their scores by marking the score on the graded line of the card. There were 21 lines with a specific date and time .Further, they had to record the day when the pain was completely relieved. Patients were recalled for several sessions on days 2, 4, 6, and 8 after receiving the treatment, to reexamine the lesion and ensure compliance with the instructions and the healing process of the lesion. When the pain and burning disappeared, the false membrane was removed. There should have been no ulcer, and the lesion was healed completely, which was recorded on the patient’s card.p ≤ 0.05 was considered for the statistical analyses.All data were fed into SPSS version 26 (software from IBM corp.) and analyzed by independent t-test, paired t-test, ANOVA for repeated measures, and survival analysis, including Kaplan-Meier and Cox regression. A significant level of p = 0.297). Both experimental groups included 30 patients (50%).Among those referred to the designated center, 75 eligible patients were recruited for the study with full consent. Fifteen patients left the study for reasons such as being far away from the dentistry school (3 patients) and unwillingness to continue the treatment (12 patients). So, the study was performed with 60 patients, of whom 36 were women (60%), and 24 were men (40%), with an age range of 18–56 years. The chi-square test showed no significant difference in the frequency of gender between the two groups (p < 0.001). For a more detailed analysis, survival analysis (Kaplan-Meier) was performed, which showed a significant difference between the two groups in terms of the duration of pain recovery and also complete recovery (p < 0.001).Data on the duration of pain and complete recovery are described in Table p = 0.825), smell (p = 0.272), satisfaction with the form of consumption (p = 0.350), and satisfaction with the treatment outcome (p = 0.394).Most patients (about 63%) were satisfied with the smell of both drugs, about 20% had no opinion, and about 7% were dissatisfied. Among the patients, about 88.33% reported that they were satisfied with the form of both drugs, 8.33% had no opinion, and 3.33% were dissatisfied. The results showed that about 60% of patients were satisfied with the taste of both drugs, 20% were dissatisfied, and 20% expressed no opinion. Information obtained showed that all patients were satisfied with the treatment outcome. The Mann-Whitney test was used to evaluate satisfaction with factors such as smell, taste, form of consumption, and treatment outcome in both groups. Results showed no significant difference between them in taste  times. Recurrent aphthous stomatitis is one of the most common oral diseases in the world and Iran, and still there is no definitive cure due to the unknown etiology. Results of this study show that Salvizan gel can be considered as a useful treatment of aphthous ulcers.Considering the problems with chemical drugs, and increasing popularity of herbal treatments, many studies have been conducted to investigate their therapeutic effects on diseases such as RAS. Mainly they obtained promising results in favor of different herbal medicines such as curcumin , coconutSalvizan gel is an almost new product in the market of Iran. Before, two studies evaluated the effects of Salvizan gel on oral diseases. In 2021, Ghalayani et al.  reportedHeretofore no study has been performed to compare the effectiveness of Sage and triamcinolone acetonide in treating aphthous ulcers in the centric population of Iran, so the present study was performed to make this comparison. The results of the present study showed that Salvizan gel is an excellent option for treating RAS. Due to the promising results of the herbal treatments and their popularity among society, researchers are suggested to conduct more studies to evaluate the effect of Sage or other herbal drugs on recurrent aphthous ulcers, in other populations.Salvizan gel is an efficient treatment for aphthous ulcers. Patients were satisfied with form, taste, and smell of both triamcinolone acetonide and Salvizan gel, but Salvizan gel performed better in reducing pain recovery and wound healing time. With these promising results, Salvizan can be considered a potential drug for treating aphthous ulcers.


The purpose of this cross-sectional study was to examine the relationship between perfectionism and pain in patients with temporomandibular disorders (TMDs). p < 0.05.  A total of 345 TMD patients were included. A questionnaire consisting of questions of demographic information, the 15-item short form of the Hewitt and Flett Multidimensional Perfectionism Scale, and the Patient Health Questionnaire-4 (PHQ-4) was distributed. According to the diagnostic criteria for TMDs, patients were categorized as pain-related (PT) and non-pain-related (NPT) groups, whereas PT patients were further divided into patients with pain-related TMDs only (OPT) and patients with combined pain-related and intra-articular TMDs (CPT). Data were analyzed using the chi-square test, Spearman's correlation, and logistic regression analysis with the significance level set at p < 0.001). The PHQ-4 score in the PT group was also higher. After adjusting the PHQ-4 scores, perfectionism scores of the PT group were 6.11 points higher than those in the NPT group (p < 0.001). There were no statistical differences in all parameters of OPT and CPT groups (p > 0.05). Perfectionism in total, other-oriented perfectionism (OOP), and socially prescribed perfectionism (SPP) showed significant but weak correlations with PHQ-4 scores (p < 0.001), while self-oriented perfectionism (SOP) was also significantly but very weakly correlated with PHQ-4 scores (p < 0.05).  There were 68 patients in the NPT group, 80 in the OPT group, and 197 in the CPT group. PT patients had significantly higher perfectionism scores (63.58 ± 13.63) than NPT patients (56.32 ± 12.95,  Pain-related TMD patients exhibited higher perfectionism scores than NPT patients, and neither their perfectionism nor pain scores were correlated with intra-articular diseases of TMJ. OOP and SOP presented weak correlations with psychological distress in TMD patients. It is suggested that pain-related TMD patients could be screened for perfectionism and perfectionism could be considered when proposing psychological treatment strategies to PT patients. Temporomandibular disorders (TMDs) are defined as a set of orofacial conditions related to abnormalities in the structure, function, or physiology of the temporomandibular joint (TMJ) and masticatory muscles which may be associated with other systemic and comorbid medical conditions . Study hThe etiology of TMDs is generally believed to be multifactorial, which comprises trauma, stress, parafunctional habits, and psychological and genetic factors, embedded in the biopsychosocial model –9. The bThe prominent definitions of perfectionism are the setting of excessively high standards on performance and self-criticism over not meeting standards , 14. PerPrevious studies have reported the association between perfectionism and diseases such as eating disorder, sleep disorder, and chronic pain. More specifically, perfectionism could affect individuals' pain catastrophizing and pain-related fear. However, to the best of our knowledge, no prior research has examined links between perfectionism and temporomandibular disorders, which is a common source of chronic orofacial pain.Thus, this study aims to explore the perfectionism of patients with temporomandibular disorders. A subsequent goal is to analyze the correlations between the perfectionism and psychological state of TMD patients. The null hypothesis was proposed that there were no differences in perfectionism between patients with or without pain-related TMDs.The ethical approval for this retrospective study was obtained from the Institutional Review Board of West China Hospital of Stomatology (no. WCHSIRB-CT-2022-241).G∗power  was used to calculate the sample size. According to our pilot study, the significance level was set as 0.05, level of β was set as 0.05 (95% power), effect size was set as 0.5, and allocation ratio was assumed as 4 : 1 (painful TMD to non-painful TMD). This calculation yielded a minimum sample size of 328 patients.Consecutive patients (≥12 years) seeking care at the Department of TMJ were recruited over a 6-month period. Eligible patients signed the informed consent when filling the questionnaires. The exclusion criteria were as follows: (1) presence of major psychiatric disorders and/or drug abuse; (2) presence of major trauma and/or operations; (3) presence of major autoimmune and/or metabolic diseases; (4) current consumption of central nervous system agents; and (5) cognitive impairment and/or illiteracy. All patients underwent a standardized examination according to Axis I of Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) .According to the DC/TMD diagnostic results, the patients were classified into two groups: the PT group, patients with pain-related TMDs, and the NPT group, patients with non-painful intra-articular TMDs, while the PT group was further subgrouped into two groups: patients with pain-related TMDs only (OPT group) and patients with combined pain-related and intra-articular TMDs (CPT group).A visual analog scale ranging from 0 to 10 was used to measure the current pain intensity (VAS-c) around the TMJ area and the worst pain intensity in the last month (VAS-m).A questionnaire designed to assess the perfectionism and general psychological status of the patients consists of three parts. Part one is about the demographic characteristics, including sex, age, education level, and family per capita monthly income.The second part is the 15-item short form of the Hewitt and Flett Multidimensional Perfectionism Scale, which involves 5 items about self-oriented perfectionism, 5 items about other-oriented perfectionism, and 5 items about socially prescribed perfectionism, respectively .The third part is the Patient Health Questionnaire-4 (PHQ-4) , which hα coefficient was used as the reliability index for the questionnaires. The inter-observer and intra-observer agreement of the VAS was assessed using the intra-class correlation coefficient (ICC).Cronbach's t-test or Mann–Whitney U test was used. The Pearson chi-square test or Fisher's exact test was used for categorical variables. Multiple linear regression models were practiced for the scores of perfectionism, which was considered as continuous dependent variable [r ≥ 0.4, a weak correlation as 0.4  >  r ≥ 0.2, and very correlation as r < 0.2. All statistical analyses were performed with the R package  and Empowerstats . An α level of 0.05 was considered statistically significant.In the case of continuous variables, the variable . Correlan = 68) and PT group (n = 277). No statistical differences were shown in demographic characteristics between the two groups .The total scores of perfectionism were 56.32 ± 12.95 in the NPT group and 63.58 ± 13.63 in the PT group, respectively. There were statistical differences in the scores of GAD-2, the three subscales of perfectionism , and the total scores of perfectionism between two groups , while SOP had significant but very weak correlation with GAD-2, PHQ-2, and PHQ-4 scores  exhibited higher perfectionism scores than the non-painful ones (NPT group). The PT group still exhibited higher perfectionism scores even with psychological scores adjusted. In addition, the study supported that perfectionism was weakly correlated with psychological status among patients. The null hypothesis we posed that there were no differences in perfectionism between the painful and non-painful TMD patients had also been proven to be valid.Cao et al.  and Yap Lombardo et al. reported that the mean scores of self-oriented perfectionism among obsessive-compulsive disorder patients were 21.50 ± 7.57, those of other-oriented perfectionism were 19.15 ± 5.94, and those of socially prescribed perfectionism were 17.58 ± 6.71, respectively , which wCompared with individuals without pain-related TMDs, those with PT had higher levels of psychological distress and worse temporomandibular-related quality of life, especially in the psychological domains. However, whether PT patients had intra-articular diseases was not associated with the psychological distress . Our stuThe biopsychosocial model posits that pain, especially chronic pain, is the result of a dynamic integration of biological processes, psychological factors, and sociocultural contexts. Emotional, cognitive, and behavioral factors could contribute to the patients' pain experience. Previous research highlights a bidirectional relationship between pain and emotional distress, in which pain is predicted by psychological struggles and psychological struggles are influenced by pain . ConsideA survey recruiting 817 participants showed that OOP and SPP were indirectly related to dysfunctional eating behaviors through the mediation of psychological distress, whereas non-significant mediation result was found for SOP . A longiThis is a pioneer study that comprehensively investigated the correlation between perfectionism and TMD pain. TMD patients with painful syndromes had a higher level of perfectionism. Thus, our study provides reference to future studies concerning the role of perfectionism on the etiology and treatments of pain-related TMDs. Besides, our study further evaluated the subdimensions of perfectionism, which preliminarily confirmed the important associations of OOP and SPP with psychological problems. As already mentioned above, SPP, also conceptualized as a perfectionistic concern, has a strong link with psychological distress like depression, stress, and anxiety.Nonetheless, our study had several limitations. The cross-sectional study has limitations in permitting casual relationships between pain, psychological distress, and perfectionism. Therefore, future prospective and longitudinal research designs are required to establish causality. Despite the satisfactory reliability and validity of PHQ-4 scale for the assessment of anxiety and depression in TMD patients , PHQ-4 sIn TMD patients, the painful individuals exhibited higher perfectionism scores than the non-painful ones, and OOP and SPP were weakly correlated with psychological distress in TMD patients.


To firstly examine the pain levels during distraction osteogenesis (DO) with lengthening nails (LN) in a large sample.A total of 168 cases underwent DO of the tibia or femur with five different models of LN. Under a standardized medical regime, daily pain levels were noted as nominal rating scale (NRS) score (0–10) during the distraction phase. NRS scores and several potential influence factors  were evaluated.The mean distraction length was 39.1 ± 14.4 mm. The average NRS score decreased from postoperative day 1 with 2.84 nonlinearly by 1.03 points (36.3%) over the course of 62 days to an average score of 1.81. The mean decrease during the first thirty days was 0.67(23.6%). Subgroup analysis did not reveal any influence factors.Pain levels during the distraction phase are overall low, continuously decreasing, and well manageable with mostly non-opioid analgesics. Distraction osteogenesis (DO) of the long tubular bones is performed in cases of limb length discrepancies due to congenital, developmental and posttraumatic/postinfectious length deficits as well as for stature lengthening due to dysplasia or in rare cases for cosmetic reasons.®) also required patients to do painful rotational movements up to 15× in a row to trigger the nail’s distraction mechanism, which explains the nickname “twist and shout” given to the Albizzia nail. High pain levels reportedly required hospital readmission in more than one third of patients treated with the Albizzia nail and distraction under general or epidural anesthesia in around 25% [® nail’s distraction rate was unreliable due to often occurring malfunction of the ratchet mechanism leading to abnormally low or high distraction rates (“runaway nail”), which has been shown to be associated with significantly higher pain levels during distraction compared to regularly functioning nails [The basic principles of DO regarding surgical technique, callus growth, distraction timing and rate were developed using circular external fixation (EF) systems and are still valid today. With EF however, pins and wires unavoidably tether and cut through the soft tissues with progressing distraction, leading to pin site infections, while the frame restricts the range of motion for the surrounding joints , 2. In cound 25% , 5. The ng nails .EF and early lengthening nails (LN) established the reputation of limb lengthening as painful procedure. Many so-called device-related complications of EF like soft tissue infections and scarring, reduced joint mobility, bone regenerate deformity, late fracture and low patient implant acceptance have been object of several studies emphasizing the reduction of those complications with LN –10. PainThe goals of this study were (1) to evaluate pain levels in a large sample with different types of LN based on patients’ daily records and (2) to investigate potential influence factors on pain like the choice of implant, patients’ age/gender, bone/side treated, and surgical approach.In an institutional review board-approved retrospective single surgeon study, patients’ daily records of pain levels during the distraction period of DO with LN were evaluated.® ISKD® Phenix® FitboneTAA SAA Precice® .Between 2003 and 2018, 224 distraction procedures of femur or tibia were performed by a single surgeon (PHT) on 201 patients using 5 different intramedullary systems (listed in order of development) in cases of posttraumatic or developmental limb length difference with or without additional axis or torsional deformity suitable for correction using intramedullary fixation :ISKD® Combined techniques of DO Dysfunctional LN .56 cases (50 patients) were excluded as one or more of the following exclusion criteria applied:A total of 168 remaining cases  were included in the study. The mean age at surgery was 28.5 ± 12.0 years. All patients kept so-called pain diaries during the distraction phase using a standardized form to document their pain level on a daily base using a nominal rating scale  to rate the average pain level of the last 24 h and document the distraction distance and frequency and note comments .The following data from our documentation of each case were added for analysis: patient’s gender and age at time of surgery, bone and side treated, LN used, surgical approach, distraction beginning, end, and pauses, distraction distance and time between surgery and beginning of full weight bearing (bone consolidation).For the femur, an antegrade or retrograde approach is used depending on several factors like patients’ age, joint condition, bone configuration and others . For minExcept for rare changes due to drug interactions, allergies, weight adaptation or other reasons, all patients were given the same medication consisting typically of pain medication according to the WHO analgesic ladder step 2 , Vitamin D3 2 × 1000 IE and Calcium 2 × 1000 mg to promote bone healing, and Enoxaparin 40 mg s.c. for deep vein thrombosis prophylaxis during the entire period of incomplete weight bearing. Nonsteroidal anti-inflammatory drugs were not given at all due to their potentially inhibiting effect on bone healing. Regularly, distraction along with pain protocols started on the third postoperative and was performed at a rate of 1 mm/day from then on. Weight bearing of 20 kg on crutches was practiced during physical therapy starting on the first postoperative day and maintained until sufficient bone consolidation was observed after the end of distraction. Hospital discharge followed regularly on the sixth day. Distraction and consolidation progress were monitored on weekly to biweekly clinic visits using focused radiographs of the distraction site with a standardized film-focus distance of 1.15 m, along with joint mobility and other clinical parameters. In the follow-ups during consolidation phase, consolidation was assessed based on both clinical and radiological criteria to determine the beginning of full weight bearing. In all cases, devices were removed about 12 months after consolidation was achieved.®, Phenix®, Fitbone TAA®, Fitbone SAA®, Precice®)LN model Surgical approach at the femur Patient’s age group Side treated Patient’s gender The daily NRS pain score and all other variables named before were collected, and the distraction index and consolidation index were calculated. As the NRS scores are a discrete and limited variable, a normal distribution was not to be expected. Univariate Kruskal–Wallis ANOVA was performed to investigate a correlation between the NRS pain score and the following variables considered by the authors to possibly influence the patients’ pain ratings significantly:Due to patients’ individual distraction goals and a therefore continuously decreasing case number, the analysis of the NRS pain levels was performed only over the time of a decrease to 25% of the initial 168 cases to ensure a sufficient sample size toward the end of the included NRS scores  with 11 patients undergoing 2 distraction treatments of different bones and 6 patients undergoing prolonged distraction treatment of one bone by using the same nail model twice in a row to generate a distraction length of up to 100 mm in one case and 160 mm in another case, the latter with a 12-month interval between treatments. FitboneA total of 113 LN were implanted into the femur, 55 into the tibia. Surgical approach to the femur was retrograde in 61 cases and antegrade in 45 cases with missing data in seven cases. The left side was treated 92× and the right side 76×.The mean distraction length was 39.1 ± 14.4 mm  during a mean distraction time of 53.6 ± 28.5 days  resulting in a mean distraction index of 0.83 ± 0.32 mm/day  or 14.1 ± 6.5 days/cm .The mean time between surgery and full weight bearing was 6.4 ± 3.5 months , resulting in a mean consolidation index of 41.2 ± 30.7 days/cm .In no case, readmission in our clinic for pain control or continuation of the distraction treatment was necessary.The highest average NRS pain was found on postoperative day 1 with 2.84 and from there on decreased nonlinearly by 1.03 points (36.3%) over the course of 62 days to an average score of 1.81 . Even the early LN  were not found to be associated with higher pain scores, as several reports on the pain status of patients treated with these implants might suggest –6.® nails, comparable to our finding of the average initial postoperative NRS pain score [® nails in 20 cases [Few other studies report results on the patients’ pain status during the distraction period with LN. They are based on comparably small sample sizes and recall ratings of several weeks to months assessed during follow-up appointments. Lee et al. report a pain score of three on the visual analogue scale (VAS) for 14 regularly distracting ISKDin score . LaubschThis study is not without limitations. Quantitative assessment of the highly subjective experience of pain is further complicated by the multifactorial nature of pain generation and perception. Psychosocial factors seem to influence the assessment and also the accuracy of remembering pain , 20. ChrIn all pain ratings that are not solely focused on the distraction process itself but on the distraction period as a section of the entire lengthening treatment, recall bias plays a more or less relevant role. The longer and the more distant the interval to be scored, the greater its potential influence. Recalled pain ratings for entire weeks or months appear to be significantly higher than for 24-h intervals of the same time period , 22. PaiLN are known to have several advantages over EF such as reduced device and distraction related complications, significantly lower pain levels for modern nails (compared to monorail EF), and an overall higher patient satisfaction with the entire lengthening treatment , 24, 25.


Pakistan has the highest incidence and mortality rates of breast cancer in Asia, with high numbers of patients diagnosed at a young age suggesting the possibility of an inherited cancer syndrome. Communication of hereditary breast cancer (HBC) risk information with patients could enable earlier detection of the condition in relatives and reduce mortality rates. This study aimed to explore perceptions of healthcare professionals (HCPs) in Pakistan about communication with patients and their relatives about HBC. Semi-structured qualitative interviews were conducted with eighteen HCPs during March to May 2020 in Lahore. Thematic analysis shows the HCPs were generally supportive of informing patients themselves about HBC, but believed it was the patients’ role to inform their relatives. HCPs also highlighted important barriers to communication with patients about HBC, including (i) patients’ low socioeconomic status and educational attainment; (ii) high prevalence of the social stigma of breast cancer; and (iii) lack of health resources and facilities to provide genetic testing for HBC. In conclusion, HCPs would value the development of interventions to support communication between HCPs and patients. They also highlighted the need for interventions to support intrafamilial communication about HBC. Much research and political support are needed to address patient, social, and systemic-level barriers to facilitate communication about HBC. Pakistan has the highest incidence and mortality rates of breast cancer (BC) in Asia GLOBOCAN . It is tA substantial number of BC patients in Pakistan are diagnosed at a young age. For example, a study on the age and stage of breast cancer in a breast unit in Karachi, Pakistan, with data collected from 1994 to 2016 , shows 22% of patients were diagnosed at 31–40 years old  shows that communication of cancer risk information is complex and difficult  in Pakistan and their at-risk relatives to facilitate early detection of the condition. To support the development of such interventions, the aim of this study was to explore perceptions of HCPs’ in Pakistan about communication with patients and their relatives about HBC.The study employed a qualitative approach, with semi-structured interviews. The interview guide was developed to explore participants’ experiences and perceptions of the prevalence of HBC and whether or not it is an issue in Pakistan, communication with patients about HBC, communication with relatives about HBC, and barriers and facilitators to such communication.Purposive sampling was used to recruit HCPs involved in the healthcare of patients with BC. Medical and nursing staff working in the oncology, radiology, pathology, and surgery departments of a public hospital in Lahore were approached by their respective heads of department. Details of interested participants were passed on to the researcher who further explained the study and arranged interviews with consenting participants (written informed consent for publication was obtained).The interviews were conducted over a 3-month period (March–May 2020), at the participants’ workplace. Interviews lasted approximately 45 min. All interviews were conducted in Urdu, audio recorded, and translated and transcribed into English by a bi-lingual researcher.Reflexive thematic analysis was used to guide data analysis HCPs agreed it was their responsibility to inform patients suspected of having HBC about the implications of the condition for their wider family:Whilst HCPs acknowledge this responsibility, they highlighted barriers to communication about HBC at patient, social, and systemic levels, and suggested solutions to facilitate such communication.Patients won’t tell others because they are going through such a difficult process themselves… For her, she herself is the most important person, rather than hearing about others… (HCP3)HCPs explained that patients’ mental and physical well-being was an important factor in considering communication about HBC. They believed the diagnosis and treatment of BC were physically and emotionally exhausting for patients; therefore, patients were unlikely to be interested in information about their relatives’ risks of HBC:…managing their anxiety and stress is more important than genetic counselling. But if the patient is admitted, we get to know them, then genetic counselling is okay. (HCP9)Nevertheless, HCPs suggested timely approaches to discussing HBC could be implemented. For example, after meeting patients’ needs and developing rapport with them:...patients that come to us aren’t educated enough. ...explaining genes to them can be difficult. (HCP16)…they lack this knowledge (BC history). (HCP15)They think this might be communicable. They ask ‘could I eat with the family?’ (HCP2)HCPs also clarified that patients attending public hospitals were usually from lower socio-economic backgrounds and had little or no education; therefore, communication about HBC would be challenging. Patients were believed to generally lack basic understandings of BC, knowledge about their family history of cancer, and as having misconceptions about BC as a communicable disease:…we should have something written to give to patients. (HCP18)…most people here cannot read… So, material should be mostly verbal… we need to use technology. (HCP3)Hence, HCPs believed patients were unlikely to understand key concepts necessary to recognise the implication of HBC for relatives. Therefore, HCPs suggested the development of information resources to support communication with patients about HBC, in written and audio formats to ensure accessibility:The majority of patients don’t disclose it to their family members... they are accused ‘this is all because of your bad deeds’. (HCP2)…people avoid patients and families with a diagnosed patient. (HCP11)...their husbands divorced them straight away, saying ‘she has cancer’. (HCP10)Based on clinical experiences, HCPs described the social stigma of BC for patients as a barrier to communication about HBC. They understood patients were often blamed for having BC, hence feared being shamed by others, social isolation, abandonment, and divorce:…women fear gossip when people get to know they went for breast screening, because there must be something wrong. (HCP5)HCPs suggested the stigma of being diagnosed with BC also led to asymptomatic women/relatives avoiding screening:…awareness in the masses is the only way…to help the general public understand the benefits of early detection. (HCP16)Everyone’s got a mobile phone. Everyone’s a pro at using Facebook, TikTok …so it would be very easy to spread information. (HCP9)…there’s a need to include religious scholars… in the villages… to educate our women. (HCP2)HCPs were concerned about the adverse social implications of advising patients to discuss HBC with asymptomatic relatives. They believed stigma attached to BC led to patients’ reluctance to disclose their diagnosis and relatives’ reluctance to consider screening. Therefore, HCPs emphasised the importance of addressing the stigma of BC through public awareness campaigns, including the use of social media platforms and discussion by religious scholars to reach diverse populations:…the Government should aim to reach people in remote areas. (HCP7)HCPs also believed the Government should raise awareness about BC, and develop and provide public BC screening programmes, with equitable access in remote, low-resourced areas:...we need assessment procedures and proper tools to calculate the risk of relatives. (HCP9)HCPs described various systemic barriers to communication with patients about HBC. They highlighted the lack of guidance documents and assessment tools to identify patients with a family history of BC.…we cannot be sure it’s inherited, because we don't have the facility to identify it as genetically inherited. (HCP2)They also had concerns about the lack of genetic testing to conclusively identify families at risk of HBC because the condition may not necessarily be inherited:...our tertiary care hospitals don’t have BRCA testing... patients have to go privately (HCP10)…they can’t afford it (genetic testing). They don’t even have money for their own treatment and medication, or to even travel to hospital... so no one will spend on tests for someone who’s ‘at-risk’. (HCP14)Furthermore, HCPs believed communication about HBC should include advice for patients and relatives about genetic testing for BRCA genes. However, they seemed conflicted about giving such advice because genetic testing was only available at a high cost in private hospitals, and most of their patients struggled with the financial implications of their treatment. The lack of realistic options for genetic testing for patients attending public hospitals was perceived by HCPs as another barrier to communication with patients about HBC:We have a lot of financial challenges and there’s no government support. (HCP9)Therefore, HCPs suggested the need for government interventions and financial support to facilitate the development of resources and facilities to support communication about HBC:Patients have an understanding that daughters may be susceptible to breast cancer. (HCP12)HCPs recognised the importance of informing patients’ relatives about HBC. They believed that understandings of the risks of developing BC, recognition of its signs and symptoms, and vigilance could enable relatives to seek earlier diagnosis and treatment. HCPs recognised that patients had lay understandings of inheritance because they were often concerned for their relatives, particularly daughters:You cannot expect quality when the number of patients outweighs the number of doctors… We should have genetic counsellors… to guide patients about it (HBC). …we can’t do it effectively due to time constraints. (HCP17)However, HCPs also believed most patients and relatives were from disadvantaged groups and had low levels of education, so would find it challenging to understand HBC. Together with limited time and resources, HCPs clarified that informing patients’ relatives about the implications of HBC themselves was beyond their remit and that their focus was on the patient. Instead, they advocated the use of trained genetic counsellors, who could dedicate more time than doctors to enable patient and their relatives to better understand HBC:...patients should tell at-risk relatives about it. (HCP11)What a layman says has minimal effect... the most important person is the family physician. (HCP4)…some leaflet along with verbal communication would be best. …even if there’s one person in the family, he can read it to relatives. (HCP15)HCPs generally believed the responsibility to inform relatives was the patients’ and their family physicians’ (as a reliable and credible source of information) and highlighted the need to develop written information to support intrafamilial communication:…we can use a leaflet, but patients may not pass information on to their relatives. (HCP7)…most (families) aren’t receptive… (HCP16)HCPs recognised that written information alone may not be sufficient to enable information dissemination about HBC within families. This was because patients may be apprehensive about informing relatives, and/or relatives may not be receptive to information due to the stigma of BC:…research articles state that breast cancer is a disease which is usually diagnosed in old age, but the age range of most patients with breast cancer here is 28-35 years. (HCP9)There was variation in HCPs’ perceptions of the prevalence of HBC in their patient population, hence the extent to which they believed it was an issue. Some HCPs quoted “almost 30% of patients” based on their experiences and others quoted “5–10%” based on the literature. Although, the latter also questioned the extent to which these figures were applicable to their patient populations given differences in the demographics of their patients (particularly age) and those in the literature:...genetic inheritance is a predisposing factor, but the precipitating factors are in our social environment… smoking and alcohol in females is common nowadays. (HCP4)HCPs also had concerns about the extent to which the incidence of BC within a family could be considered as “genetically inherited” versus “familial due to lifestyle choices”:Unless we test patients for mutations, we can’t claim that it’s inherited. (HCP2)HCPs added that although a patient’s family history may indicate HBC, confirmatory genetic testing was necessary to ascertain a clinical diagnosis; otherwise, there was a risk of mislabelling families with HBC:Overall, based on their observations of large proportions of young women with BC and multiple women from the same family with the condition, HCPs acknowledged the importance of communication with patients about HBC. However, they also cautioned against labelling families as having HBC without a genetic diagnosis.HCPs acknowledged their responsibility in informing patients about HBC and the implications of the condition for family members, but then it was the patients’ responsibility to inform their relatives. Although there was a consensus that HCPs should support intrafamilial communication, HCPs also suggested the need to overcome patient, social and systemic level barriers to enable effective communication about HBC.Perceived challenges to effective communication about HBC with patients were related to the low socio-economic backgrounds of patients attending public hospitals. Such patients were generally believed to have limited education/health literacy, hence limited knowledge of BC, inheritance or family history of cancer, and misconceptions about the cause of the condition. These findings highlight the need for developing accessible information resources, using plain language, to support communication with patients about HBC and its implications for relatives. Whilst resources have been developed for use in HICs, research is needed to co-develop similar resources locally with HCPs and BC patients with low literacy and for use in a context with limited access to genetic testing . Therefore, there is a need for genetic testing, so that HCPs may communicate with patients about HBC based on clinical evidence for the condition. Genetic testing is further justified by studies showing that BRCA mutations account for a substantial proportion of HBC and early-onset BC cases in Pakistan  NICE , and assHCPs considered communication with patients’ relatives about HBC beyond their remit. This finding aligns with research emphasising that patients are ultimately responsible for intrafamilial communication , albeit for thalassaemia only. The sustained and successful achievements of this organisation in the prevention of thalassaemia for over a decade have led to further funding from the Government of Punjab, which now includes the prevention of other genetic conditions. This enhanced service will be known as the Punjab Thalassaemia and Other Genetic Disorder Prevention and Research Institute. Therefore, it is timely for policymakers and HCPs to consider how this organisation could include genetic testing and counselling services for HBC.Genetic counselling can also play an important role in facilitating intrafamilial communication, providing crucial support for HCPs with limited time. However, HCPs in Pakistan have little training on genetic counselling. Unlike HICs, genetic counselling is not a part of the healthcare system in Pakistan. Nevertheless, genetic counselling is available via the Government-funded “Punjab Thalassaemia Prevention Programme” (HCPs in our study had different views about the extent to which HBC was an issue. The prevalence of BC and HBC is not known in Pakistan because of the lack of national BC registries and epidemiological studies, so there is little evidence on the extent to which HBC is an issue in Pakistan. To inform policy and the development of genetic services for HBC, epidemiological research is needed on this in Pakistan. Such research could better enable HCPs to recognise the need for informing patients about HBC and intrafamilial communication with at-risk relatives.This study presents an in-depth insight of HCPs’ perceptions of communication with patients and their families about HBC in a low–middle-income country. The study is limited to HPCs in a public sector hospital in the Punjab province. Further research is needed with HCPs working in the private sector and in other provinces. Also, the study includes mainly female HCPs. This is because few males enter the field of breast cancer in Pakistan.In conclusion, our findings suggest HCPs would value the development of interventions to support communication between HCPs and patients and intrafamilial communication between patients and relatives about HBC. Much research and political support are needed to address patient, social, and systemic-level barriers to facilitate HCPs’ communication about HBC.