Aromatherapy in childbirth: a pilot randomised controlled trial. Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial. Can just-in-time, evidence-based "reminders" improve pain management among home health care nurses and their patients? Prediction of relapse in schizophrenic outpatients treated by drug and sociotherapy. Partogram action line study: a randomised trial. Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea. Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa. Towards a model stroke trial. The single-centre naftidrofuryl study. Acupuncture and infertility: we need to stick to good science. Improving prevention systems in primary care practices: the Health Education and Research Trial (HEART) Fetal health surveillance: a community-wide approach versus a tailored intervention for the implementation of clinical practice guidelines.
We aimed to determine the feasibility of conducting a randomised controlled trial (RCT) on the use of aromatherapy during labour as a care option that could improve maternal and neonatal outcomes.
                RCT comparing aromatherapy with standard care during labour.
                District general maternity unit in Italy.
                Two hundred and fifty-one women randomised to aromatherapy and 262 controls.
                Participants randomly assigned to administration of selected essential oils during labour by midwives specifically trained in their use and modes of application.
                Intrapartum outcomes were the following: operative delivery, spontaneous delivery, first- and second-stage augmentation, pharmacological pain relief, artificial rupture of membranes, vaginal examinations, episiotomy, labour length, neonatal wellbeing (Apgar scores) and transfer to neonatal intensive care unit (NICU).
                There were no significant differences for the following outcomes: caesarean section (relative risk [RR] 0.99, 95% CI: 0.70-1.41), ventouse (RR 1.5, 95% CI: 0.31-7.62), Kristeller manoeuvre (RR 0.97, 95% CI: 0.64-1.48), spontaneous vaginal delivery (RR 0.99, 95% CI: 0.75-1.3), first-stage augmentation (RR 1.01, 95% CI: 0.83-1.4) and second-stage augmentation (RR 1.18, 95% CI: 0.82-1.7). Significantly more babies born to control participants were transferred to NICU, 0 versus 6 (2%), P = 0.017. Pain perception was reduced in aromatherapy group for nulliparae. The study, however, was underpowered.
                This study demonstrated that it is possible to undertake an RCT using aromatherapy as an intervention to examine a range of intrapartum outcomes, and it provides useful information for future sample size calculations. A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size.
                Copyright 2001 John Wiley & Sons, Ltd. The purpose of this randomized, controlled, home care intervention was to test the effectiveness of two nurse-targeted, e-mail-based interventions to increase home care nurses' adherence to pain assessment and management guidelines, and to improve patient outcomes. Nurses from a large urban non-profit home care organization were assigned to usual care or one of two interventions upon identification of an eligible cancer patient with pain. The basic intervention consisted of a patient-specific, one-time e-mail reminder highlighting six pain-specific clinical recommendations. The augmented intervention supplemented the initial e-mail reminder with provider prompts, patient education material, and clinical nurse specialist outreach. Over 300 nurses were randomized and outcomes of 673 of their patients were reviewed. Data collection involved clinical record abstraction of nurse care practices and patient interviews completed approximately 45 days after start of care. The intervention had limited effect on nurse-documented care practices but patient outcomes were positively influenced. Patients in the augmented group improved significantly over the control group in ratings of pain intensity at its worst, whereas patients in the basic group had better ratings of pain intensity on average. Other outcomes measures were also positively influenced but did not reach statistical significance. Our findings suggest that although reminders have some role in improving cancer pain management, a more intensive approach is needed for a generalized nursing workforce with limited recent exposure to state-of-the-art pain management practices. Despite the established efficacy of neuroleptics for maintaining schizophrenics in the community, there are data suggesting that those with very good prognostic signs may do as well without drugs. In testing this, we find no evidence that patients with good signs are not in need of drugs; instead they profit most from drug treatment. Patients who benefit little (1) are men whose families were disrupted earlier in their lives, (2) live alone or with extended families whose attitudes toward the study are not positive, and (3) are irregular in taking their medication. The practical implication is that the drug nonresponder can be helped by some means to ensure regularity of medication taking, such as a visiting nurse or long-acting medication. A second research question is whether major role therapy (MRT, a combination of social casework and vocational rehabilitation) can lengthen the time until relapse. Major role therapy affected time to relapse in a disordinal manner; asymptomatic patients benefited from MRT, while in patients with greater symptom severity MRT- suprisingly--hastened relapse. It is hypothesized that symptomatic patients are suffering from an inability to manage an expanded and enriched cognitive field; MRT, a therapy that urges the patient to become more responsible and to expand his horizons, may actually induce a state with which the patient cannot cope. It is recommended that a therapy such as MRT be deferred until the patient is essentially asymptomatic. To assess the effect of three different partograms on caesarean section and maternal satisfaction.
                Prospective randomised clinical trial.
                Regional teaching hospital in North West of England.
                Nine hundred and twenty-eight primigravid women with uncomplicated pregnancies who presented in spontaneous labour at term.
                The women were randomised to have their progress of labour recorded on a partogram with an action line 2, 3 or 4 hours to the right of the alert line. If the progress reached the action line, a diagnosis of prolonged labour was made. Prolonged labour was managed according to the standard ward protocol.
                Primary: Caesarean section rate and maternal satisfaction; secondary: need for augmentation, duration of labour, analgesia, cord blood gas analysis, postpartum haemorrhage, number of vaginal examinations, Apgar score and admission to special care baby unit.
                Caesarean section rate was lowest when labour was managed using a partogram with a 4-hour action line. The difference between the 3- and 4-hour partograms was statistically significant (OR 1 8, 95% CI 1.1-3.2), but the difference between 2 and 4 hours was not (OR 1.4, 95% CI 0.8-2.4). The women in the 2-hour arm were more satisfied with their labour when compared to the women in the 3-hour (P < 00001) and 4-hour (P <00001) arm.
                Our data suggest that women prefer active management of labour. It is possible that partograms which favour earlier intervention are associated with higher caesarean section rate. As the evidence on which to base the choice of partograms remains inconclusive further research is required. To determine whether aromatherapy can reduce postoperative nausea, the investigators studied 33 ambulatory surgery patients who complained of nausea in the PACU. After indicating the severity of nausea on a 100-mm visual analogue scale (VAS), subjects received randomized aromatherapy with isopropyl alcohol, oil of peppermint, or saline (placebo). The vapors were inhaled deeply through the nose from scented gauze pads held directly beneath the patients' nostrils and exhaled slowly through the mouth. Two and 5 minutes later, the subjects rated their nausea on the VAS. Overall nausea scores decreased from 60.6 +/- 4.3 mm (mean +/- SE) before aromatherapy to 43.1 +/- 4.9 mm 2 minutes after aromatherapy (P <.005), and to 28.0 +/- 4.6 mm 5 minutes after aromatherapy (P < 10(-6)). Nausea scores did not differ between the treatments at any time. Only 52% of the patients required conventional intravenous (IV) antiemetic therapy during their PACU stay. Overall satisfaction with postoperative nausea management was 86.9 +/- 4.1 mm and was independent of the treatment group. Aromatherapy effectively reduced the perceived severity of postoperative nausea. The fact that a saline "placebo" was as effective as alcohol or peppermint suggests that the beneficial effect may be related more to controlled breathing patterns than to the actual aroma inhaled. Behavioral and psychological symptoms in dementia are frequent and are a major management problem, especially for patients with severe cognitive impairment. Preliminary reports have indicated positive effects of aromatherapy using select essential oils, but there are no adequately powered placebo-controlled trials. We conducted a placebo-controlled trial to determine the value of aromatherapy with essential oil of Melissa officinalis (lemon balm) for agitation in people with severe dementia.
                Seventy-two people residing in National Health Service (U.K.) care facilities who had clinically significant agitation in the context of severe dementia were randomly assigned to aromatherapy with Melissa essential oil (N = 36) or placebo (sunflower oil) (N = 36). The active treatment or placebo oil was combined with a base lotion and applied to patients' faces and arms twice a day by caregiving staff. Changes in clinically significant agitation (Cohen-Mansfield Agitation Inventory [CMAI]) and quality of life indices (percentage of time spent socially withdrawn and percentage of time engaged in constructive activities, measured with Dementia Care Mapping) were compared between the 2 groups over a 4-week period of treatment.
                Seventy-one patients completed the trial. No significant side effects were observed. Sixty percent (21/35) of the active treatment group and 14% (5/36) of the placebo-treated group experienced a 30% reduction of CMAI score, with an overall improvement in agitation (mean reduction in CMAI score) of 35% in patients receiving Melissa balm essential oil and 11% in those treated with placebo (Mann-Whitney U test; Z = 4.1, p < .0001). Quality of life indices also improved significantly more in people receiving essential balm oil (Mann-Whitney U test; percentage of time spent socially withdrawn: Z = 2.6, p = .005; percentage of time engaged in constructive activities: Z = 3.5, p = .001).
                The finding that aromatherapy with essential balm oil is a safe and effective treatment for clinically significant agitation in people with severe dementia, with additional benefits for key quality of life parameters, indicates the need for further controlled trials. It has been questionable whether the lack of proven pharmacological treatments in acute cerebral infarction (ACI) reflects ineffective drugs or only inadequacies in their assessment. The difficulties in developing a rationale for drug therapy in this condition favoured the former, although the latter possibility was supported by re-evaluation of most published trials. In this paper, a plausible rationale, in terms of our current understanding of both the drug and the condition, is expounded for treatment of ACI with naftidrofuryl. Guidelines for the design and conduct of clinical trials in acute stroke are discussed in relation to the particular problems posed: need for early initiation of treatment; need for, and difficulties of, diagnostic confirmation; matching of treatment groups by prognostic indicators of uncertain significance, and requirements for large numbers of patients and long-term follow-up. The practical application of these guidelines is tested in a clinical trial of naftidrofuryl conducted in a single centre on 100 patients with proven diagnoses. Rigorous attention to all aspects of selection, treatment and follow-up, with an explanatory approach to the trial design, was predicted to produce a positive result if the drug was effective. The findings were that naftidrofuryl treatment was associated with no change in death rate but with clinically and statistically significant improvements in neurological recovery and bed-occupancy. Better functional recovery was also noted, so that the trial result was coherent. It was concluded that a beneficial effect had been recorded, and consistency of this outcome with those of previous studies is demonstrated. A case is made for further studies to define exactly the role of this drug in the management of ACI. The research published to date does not show a definitive positive impact of acupuncture on IVF success rates. However, researchers seem to lack traditional scientific practices when interpreting the data. The Health Education and Research Trial (HEART) was a multicenter clinical trial designed to test methods to improve primary care practice systems for heart disease prevention services. We present the trial methodology, the practices' use of medical record tools, and changes in documentation of cardiovascular risk factor screening and management.
                Primary care practices were recruited from 4 Midwestern states. The factorial design resulted in 4 study groups: conference only, conference and quality improvement consultations, conference and prevention coordinator, and all interventions combined. Medical record audits and physician, staff, and patient surveys assessed practice change in cardiovascular disease risk factor documentation.
                Practices participated fully in this project, set goals to improve preventive services, and implemented recommended medical record tools. The number of goals set and the increase in the use of medical record tools were greatest in the combined intervention group, with improvements noted in all groups. The use of patient history questionnaires, problem lists, and flow sheets was significantly higher in the combined intervention group when compared with the conference-only group. Documentation of risk factor screening in a recommended-medical record location improved in all intervention groups, with significant sustained improvements in the practices that received the combined intervention. Documented risk factor management significantly improved in all intervention groups compared with the conference-only control.
                Primary care practices are interested in improving prevention systems and can change these systems in response to supportive external interventions. Promoting organizational change to produce sustained improvement in preventive service clinical outcomes is a complex process that requires further research. The decreased use of electronic fetal monitoring (EFM) for healthy women in labour and the increased provision of professional support to all women in labour is recommended by experts. We evaluated the effectiveness of a community-wide approach to transferring research results to practice using a regional committee, newsletter articles and annual conference presentations compared with an additional tailored hospital intervention involving workshops to enhance self-efficacy for nurses, policy review, multidisciplinary meetings, rounds and unit discussions.
                We compared the proportion of women at low risk who received EFM and the proportion of nurses' time spent providing labour support before and after the intervention within each of 4 hospitals (2 tertiary and 2 secondary). One hospital of either type was randomly selected to receive the tailored intervention. Randomly selected charts (n = 200) were reviewed for the use of EFM at each hospital before (1995) and after (1996) the intervention. Trained observers at randomly selected times recorded the nurses' activities, including time spent providing labour support before and after the intervention.
                At the intervention secondary hospital, there was a large decrease in the use of EFM, from 90.1% before to 41.0% after the intervention (p < 0.001), but no change in nurses' time spent providing labour support. At the intervention tertiary hospital there was no change in EFM rates, but there was a small, statistically significant increase in time spent providing labour support (23.5% to 29.8%, p < 0.001). A negative effect on time spent providing labour support was found at the control secondary hospital (decrease from 19.6% to 12.8%, p < 0.001), with no change in the EFM rate. At the control tertiary hospital there was a small decrease in the use of EFM, from 99.5% to 91.4% (p < 0.001), but no change in time spent providing labour support.
                The results are mixed, and the tailored intervention thus appeared to have limited effects. No association was found between the reduction in the use of EFM and an increase in nurses' time spent providing labour support.
There is a lack of studies evaluating the role of aromatherapy for pain management in labour. Further research is needed before recommendations can be made for clinical practice.