The Effects of Connective Tissue Massage and Music-Based Progressive Muscle Relaxation on Pain Intensity, Pressure Pain Threshold, and Menstruation-Related Symptoms in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
This randomized controlled clinical trial aims to investigate the effects of Connective Tissue Massage (CTM) and music-based Progressive Muscle Relaxation Training (PMRT) on pain intensity, pressure pain threshold, analgesic use, and menstruation-related symptoms in women with primary dysmenorrhea. Participants will be randomly assigned to one of three groups: CTM, music-based PMRT, or control. Baseline assessment will be conducted during menstrual days 1-2 of Cycle 0. The interventions will be applied during the premenstrual intervention window of Cycle 0, from the estimated ovulation day, calculated as cycle length minus 14 days, until Cycle 1 Day 1. Post-intervention assessment will be conducted during menstrual days 1-2 of Cycle 1. No intervention will be applied after the post-intervention assessment, and follow-up assessment will be conducted during menstrual days 1-2 of Cycle 2. Outcomes including pain intensity, pressure pain threshold, analgesic use, menstrual symptoms, attitudes toward menstruation, functional and emotional impact of dysmenorrhea, and pain catastrophizing will be evaluated across menstrual cycles. Participant satisfaction and adherence to the interventions will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to group allocation. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of primary dysmenorrhea made by a Gynecology and Obstetrics specialist
- •Being between 18-30 years of age
- •Being nulliparous
- •Having a regular menstrual cycle (28 ± 7 days)
- •Having menstrual pain intensity greater than 4 cm on the Visual Analog Scale for the last 6 months
- •Voluntarily agreeing to participate in the study
排除标准
- •Having been diagnosed at least 6 months prior with gastrointestinal, urogynecological, autoimmune, or psychiatric diseases and/or chronic pain syndromes
- •Having any neurological or systemic disease
- •Having a history of childbirth or previous pregnancy
- •Being pregnant
- •Using an intrauterine device (IUD)
- •Having any pelvic pathology or history of pelvic surgery
- •Chronic use of medications, including oral contraceptives or antidepressants
- •Currently receiving anti-inflammatory, analgesic, or psychotherapeutic drug treatment
- •Having irregular menstrual cycles (<21 or >35 days and/or cycle variation >4 days)
- •Presence of pathology indicating secondary dysmenorrhea
研究组 & 干预措施
Connective Tissue Massage Group
Participants in this group will receive Connective Tissue Massage. The intervention will be applied to the sacrolumbar, lower thoracic, abdominal, and anterior pelvic regions. Sessions will be performed five days per week during the Cycle 0 premenstrual intervention window, from the estimated ovulation day, calculated as cycle length minus 14 days, until Cycle 1 Day 1. Each session will last approximately 10-15 minutes.
干预措施: Connective Tissue Massage (Other)
Music-Based Progressive Muscle Relaxation Group
Participants in this group will receive music-based Progressive Muscle Relaxation Training. Participants will receive face-to-face instruction at the beginning of the study, and the first session will be conducted in person. Thereafter, participants will perform the training using approved audio recordings from the Turkish Psychological Association. Sessions will be performed five days per week during the Cycle 0 premenstrual intervention window, from the estimated ovulation day, calculated as cycle length minus 14 days, until Cycle 1 Day 1. Each session will last approximately 20-30 minutes.
干预措施: Music-based Progressive Muscle Relaxation (Other)
Control Group
Participants in the control group will not receive any intervention during the study period. They will be asked not to receive complementary interventions that may reduce menstrual pain or promote relaxation, such as acupuncture, massage, or other mind-body techniques. Participants will continue their routine daily activities without restriction. After completion of the study, participants in the control group will be offered Connective Tissue Massage or music-based Progressive Muscle Relaxation Training according to their preference.
研究者
Raziye Şavkın
Associate Professor
Pamukkale University