About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Connective Tissue Massage
Other interventionConnective tissue manipulation will be applied to the sacrolumbar, lower thoracic, abdominal, and anterior pelvic regions. The intervention 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.
Music-based Progressive Muscle Relaxation
Other interventionParticipants will receive music-based Progressive Muscle Relaxation Training (PMRT) using recordings from the Turkish Psychological Association's Relaxation Exercises CD. At the beginning of the study, participants will be informed face-to-face about the purpose, procedure, and breathing techniques of PMRT, and the first session will be conducted in person. Thereafter, PMRT sessions will be performed using the approved audio recordings. The intervention 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.
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity
Participants' menstrual pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will be asked to rate the average pain intensity experienced during the first two days of menstruation, the average pain intensity experienced throughout the menstrual period, and the worst pain intensity experienced during menstruation. The VAS is widely used in clinical practice and scientific research to assess pain perception. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Secondary outcomes
Pain Catastrophizing Scale
The Pain Catastrophizing Scale will be used to assess catastrophizing related to menstrual pain. The scale consists of 13 items and three subscales: helplessness, magnification, and rumination. Participants will be asked to rate the extent to which they experienced each thought or feeling during menstrual pain on a five-point scale ranging from 0 to 4. Higher scores indicate greater pain catastrophizing.
Functional and Emotional Dysmenorrhea Scale
The Functional and Emotional Dysmenorrhea Scale will be used to assess the functional and emotional impact of dysmenorrhea. The scale consists of 14 items and two subscales. Higher scores indicate a greater functional and emotional impact of dysmenorrhea.
Menstrual Attitude Scale
The Menstrual Attitude Scale will be used to assess attitudes toward menstruation. The scale consists of 33 items across five categories: menstruation as a debilitating phenomenon, menstruation as a disturbing phenomenon, menstruation as a natural phenomenon, anticipation/perception of menstruation, and denial of the effects of menstruation. Each item is rated on a five-point scale ranging from 1 to 5. Higher scores indicate a more positive attitude toward menstruation.
Menstrual Symptom Scale
The Menstrual Symptom Scale will be used to assess menstrual pain and related symptoms. The scale consists of 22 items evaluating menstruation-related symptoms and is rated on a five-point Likert scale ranging from never to always. The scale comprises three subscales: Negative Effects/Somatic Complaints, Menstrual Pain Symptoms, and Coping Strategies. Higher mean scores indicate greater severity of menstrual symptoms within the corresponding subscale.
Other outcomes
Intervention Satisfaction
Participants' satisfaction with the Connective Tissue Massage or Music-Based Progressive Muscle Relaxation Training interventions will be assessed using a 10-cm Visual Analog Scale through two questions: "How satisfied were you with the overall treatment you received?" and "Would you recommend this treatment and/or advice to someone you know who suffers from menstrual pain?" Scores range from 0 to 10, with higher scores indicating greater satisfaction or stronger recommendation.
Intervention Adherence
Participants' adherence to Connective Tissue Massage sessions will be recorded by the researcher who administers the intervention. Participants in the Music-Based Progressive Muscle Relaxation Training group will record their sessions in a relaxation diary. Adherence will be calculated as the percentage of completed sessions relative to the planned number of sessions. Adherence will be classified as good, moderate, or low.
Sponsors and contacts
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Pamukkale University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator