Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial.

Considering the pharmacological treatment options for endometriosis-associated pain are confined to hormonal therapy and analgesics, we studied the analgesic effect of 20 mg melatonin as an adjuvant therapy in women with endometriosis-associated pain. This randomized double-blinded, placebo-controlled trial was conducted at the Research Center for Womens' Health at Södersjukhuset, a university hospital in Stockholm, Sweden. Forty women from 18 to 50 years of age with endometriosis and severe dysmenorrhea with or without chronic pelvic pain were given 20 mg Melatonin or placebo orally daily for two consecutive menstrual cycles or months. The level of pain was recorded daily on the 11-point numeric rating scale, a difference of 1.3 units was considered clinically significant. Clincaltrials.gov nr NCT03782740. Sixteen participants completed the study in the placebo group and 18 in the melatonin group. The difference in endometriosis-associated pain between the groups showed to be non-significant statistically as well as clinically, 2.9 (SD 1.9) in the melatonin group and 3.3 (SD 2.0) in the placebo group, p = 0.45. This randomized, double-blinded, placebo-controlled trial could not show that 20 mg of melatonin given orally at bedtime had better analgesic effect on endometriosis-associated pain compared with placebo. No adverse effects were observed.

Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial.

PURPOSE: Dysmenorrhea is a common, recurring, painful condition with a global prevalence of 71%. The treatment regime for dysmenorrhea includes hormonal therapies and NSAID, both of which are associated with side effects. A dose of 10 mg melatonin daily has previously been shown to reduce the level of pelvic pain in women with endometriosis. We chose to investigate how this regime, administered during the week of menstruation, would affect women with dysmenorrhea but without any signs of endometriosis, as adjuvant analgesic treatment. METHODS: Forty participants with severe dysmenorrhea were randomized to either melatonin or placebo, 20 in each group. Our primary outcome was pain measured with numeric rating scale (NRS); a difference of at least 1.3 units between the groups was considered clinically significant. Secondary outcomes were use of analgesics, as well as absenteeism and amount of bleeding. Mixed model was used for statistical analysis. RESULTS: Eighteen participants completed the study in the placebo group and 19 in the melatonin group. Mean NRS in the placebo group was 2.45 and 3.18 in the melatonin group, which proved to be statistically, although not clinically significant. CONCLUSION: This randomized, double-blinded, placebo-controlled trial could not show that 10 mg of melatonin given orally at bedtime during the menstrual week had better analgesic effect on dysmenorrhea as compared with placebo. However, no adverse effects were observed. CLINICAL TRIALS: NCT03782740 registered on 17 December 2018.

Understanding the barriers and myths limiting the use of intrauterine contraception in nulliparous women: results of a survey of European/Canadian healthcare providers.

OBJECTIVES: To evaluate healthcare providers' (HCPs') knowledge, attitudes and beliefs regarding intrauterine contraception (IUC). STUDY DESIGN: HCPs in eight European countries and Canada who saw at least 20 women per month for contraception completed an online questionnaire. Responses were evaluated by country. RESULTS: In total, 1103 HCPs completed the survey: 633 obstetrician-gynecologists, 335 general practitioners and 135 family planning clinicians (physician, midwife or nurse). When respondents in different countries were asked to report their three main barriers to considering IUC, predominant concerns were nulliparity (34-69%) and pelvic inflammatory disease (PID; 14-83%) for women in general, and insertion difficulty (25-83%), PID (17-83%), insertion pain (7-60%) and infertility (6-55%) for nulliparous women. In addition, 4-59% of HCPs reported that they never proactively include IUC in contraceptive counseling for a nulliparous woman, regardless of her age. Furthermore, only 30-61% of respondents correctly identified that, in the World Health Organization medical eligibility criteria for IUC, nulliparity is category 2 (benefits outweigh risks). CONCLUSIONS: HCPs in Europe and Canada have clear gaps in their knowledge regarding IUC and misplaced concerns persist, particularly regarding use of IUC in nulliparous women; the predominant misconceptions are about PID, insertion difficulty and insertion pain. Further education on the evidence is needed so that IUC is recognized as being suitable for young and nulliparous women and is included in contraceptive counseling.

Pregnancy termination due to fetal anomaly: women's reactions, satisfaction and experiences of care.

OBJECTIVE: to explore what women who have had a pregnancy terminated due to a detected fetal malformation perceived as having been important in their encounters with caregivers for promoting their healthy adjustment and well-being. METHOD: an exploratory descriptive design was used. Semi-structured interviews were audiotaped, and the information pathway described. The text was processed through qualitative content analysis in six steps. SETTING: four fetal care referral centres in Stockholm, Sweden. PARTICIPANTS: 11 women opting for pregnancy termination due to fetal malformation. FINDINGS: in-depth understanding and compassion are important factors in providing the feeling of support people need so they are able to adapt to crisis. The women emphasised that the caregivers have to communicate a sense of responsibility, hope and respect and provide on-going care for them to feel assured of receiving good medical care and treatment. Aside from existing psychological conditions, the women identified as having emotional distress directly after termination and for at least the following three months. Most women experienced a range of negative emotions after pregnancy termination, including sadness, meaninglessness, loneliness, tiredness, grief, anger and frustration. Still some of this group had positive reactions because they experienced empathy and well-organised care. CONCLUSION AND IMPLICATIONS FOR PRACTICE: The most important factors associated with satisfaction regarding pregnancy termination due to a fetal malformation are the human aspects of care, namely state-dependent communication and in-depth understanding and compassion. The changes in care most often asked for were improvements in the level of standards and provision of adequate support through state-dependent communication, in-depth understanding and compassion, and complete follow-up routines and increased resources. Targeted education for the caregivers may be suited to ensuring that they properly meet needs of their patients.

Pregnant women's experiences, needs, and preferences regarding information about malformations detected by ultrasound scan.

OBJECTIVES: The aim of the study was to explore pregnant women's experiences of received information in relation to fetal malformation detected on ultrasound. METHOD: An exploratory descriptive design was used. Semi-structured interviews with women who continued their pregnancy and women who chose to terminate were audiotaped, the information pathway described, and the text subjected to qualitative content analysis. RESULTS: Most of the women who expected a baby with an abnormality experienced the information given as insufficient, often misleading, conflicting, or incoherent, and sometimes negative. Important factors for interaction between women and caregivers were timing, duration, and manner of the initial dialog and ongoing support. Positive interactions improved the women's ability to understand the information, fostered feelings of trust and safety which reduced their anxiety. CONCLUSION: Women expressed dissatisfaction both regarding the care-givers' methods of giving information and apply for information from different specialists and continuity. The study highlights important factors which may be helpful to the professionals for improving the information to this vulnerable group of women.

Effect of a peer-educational intervention on provider knowledge and reported performance in family planning services: a cluster randomized trial.

BACKGROUND: Peer education is an interactive method of teaching or learning which is widely used for educating school and college students, in a variety of different forms. However, there are few studies on its effectiveness for in-service education. The aim of this study was to evaluate the effect of an educational programme including peer discussions, based on a needs assessment, on the providers' knowledge and reported performance in family planning services. METHODS: An educational programme was designed and applied in a random selection of half of in-charges of the 74 family health units (intervention group) in Tabriz at a regular monthly meeting. The other half constituted the control group. The programme included eight pages of written material and a two-hour, face-to-face discussion session with emphasis on the weak areas identified through a needs assessment questionnaire. The educated in-charges were requested to carry out a similar kind of programme with all peers at their health facilities within one month. All in-charges received one self-administered questionnaire containing knowledge questions one month after the in-charge education (follow-up I: 61 responses), and another one containing knowledge and self-reported performance questions 26 months later (follow-up II: 61 responses). Also, such tests were done for the peers facilitated by the in-charges one (105 responses) and 27 months (114 responses) after the peer discussions. Multiple linear regression was used for comparing mean total scores, and Chi square for comparing proportions between control and intervention groups, after defining facility as the unit of randomization. RESULTS: The mean total percentage scores of knowledge (percent of maximal possible score) in the intervention group were significantly higher than in the control group, both at follow-up I (63%) and at follow-up II (57%); with a difference of 16 (95% CI: 11, 22) and 5 (95% CI: 0.4, 11) percentage units, respectively. Only two of the nine reported performance items were significantly different among the non in-charges in the intervention group at follow-up II. CONCLUSIONS: The educational programme including peer discussions using existing opportunities with no need for additional absence from the workplace might be a useful complement to formal large group education for the providers.