The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial.

BACKGROUND: Lactation has a negative effect on female sexual function. Hormonal changes during lactation cause changes which might lead to dyspareunia, lack of libido, and anorgasmia. There are various pharmacological and non-pharmacological approaches to treat sexual dysfunction. While pharmacological treatment has multiple unwanted side effects, non-pharmacological therapies such as complementary medicine are a potential safer alternative. The aim of this study is to evaluate the effect of ear acupressure on sexual function of lactating women. METHODS/DESIGN: This is a randomized clinical trial with a parallel sham control group. In this study, 76 lactating women between 6 months and 1 year after childbirth were referred to health care centers in Qazvin City and would be invited to participate. Participants will be divided into intervention (n = 38) and control (n = 38) groups using simple block randomization. Both intervention and sham control groups will be visited over 10 sessions within a 4-day interval. At each visit, the adhesives containing Vaccaria seed will be adhered for the intervention group, while non-latex-based adhesives with no Vaccaria seeds will be placed on the same ear acupoints for the sham control group. Selected ear acupoints include genitalia (two ear points), pelvic point, master shoulder, and posterior pituitary gland. The women will be asked to hold the seeds on their ears for 3 days and press each ear point three times a day for 20 s. After 3 days, they will be asked to remove the seeds from their ears and rest for 1 day. Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention. Also, Sexual Quality of Life as secondary outcome will be assessed using Sexual Quality of Life-Female (SQOL-F) before and 2 months after intervention. Data will be analyzed using repeated measure ANOVA at the significant level of 0.05. DISCUSSION: This study is expected to support the impact of ear channel ear acupressure on sexual function in lactating women. TRIAL REGISTRATION: Iranian Clinical Trial Registration Center IRCT20190626044028N1 . Registered on 16 August 2019.

The effect of psychoeducational intervention, based on a self-regulation model on menstrual distress in adolescents: a protocol of a randomized controlled trial.

INTRODUCTION: Menstrual distress caused by primary dysmenorrhea is associated with physical and psychological symptoms-before, after, and during menstruation. Leventhal's self-regulation educational model is based on the cognitive and emotional experiences of threat responses to symptoms and relates to coping responses. This study aims to investigate the effect of the implementation of a psychoeducational intervention, based on the self-regulation model of menstrual distress in adolescents. METHODS/DESIGN: In this randomized controlled trial, 120 adolescent girls with moderate to severe menstrual pain (based on visual analog scale (VAS) ≥ 4) from twelve randomly selected high schools in Qazvin City will be enrolled in the study and will be randomly assigned to either a 3-session psychoeducational intervention (n = 60) or control (n = 60) groups. The sessions will be between 60 and 90 min apiece, and they will run for three consecutive weeks (one session per week). The data collection tools will include questionnaire eliciting menstrual information and demographics, the VAS, the Moos Menstrual Distress Questionnaire, and the illness perception questionnaire. One month prior to the intervention, both groups will participate in an initial assessment to assess the severity of their pain and level of menstrual distress. Finally, all questionnaires will be completed for three consecutive months after the intervention is completed. DISCUSSION: It is anticipated that findings of this study will provide evidence for the effectiveness of the Leventhal self-regulation model. Implications for improved practice, understanding, and treatment for menstrual distress may also arise. ETHICAL CONSIDERATIONS: The research protocol will be reviewed by the ethics committee, which is affiliated with the Qazvin University of Medical Sciences (Decree code: IR.QUMS.REC.1398.043). TRIAL REGISTRATION: IRCT20190625044002N1 . Registration date: 2019-09-03.