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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective Tissue Massage Group | Experimental | 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. |
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| Music-Based Progressive Muscle Relaxation Group | Experimental | 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. |
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| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective Tissue Massage | Other | Connective 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamukkale University, Faculty of Physiotherapy and Rehabilitation | Recruiting | Denizli | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a three-arm, parallel-group, randomized controlled clinical trial. Eligible participants with primary dysmenorrhea will be randomly assigned to one of three groups: Connective Tissue Massage, Music-Based Progressive Muscle Relaxation Training, or Control. Interventions will be delivered over two consecutive intervention menstrual cycles following baseline assessment. No intervention will be delivered before the follow-up assessment, which will be conducted during the first menstrual cycle after cessation of the intervention.
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The outcome assessor will be blinded to group allocation. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
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| Music-based Progressive Muscle Relaxation | Other | Participants 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. |
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| Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| 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. | Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| 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. | Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| 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. | Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| Pain Threshold | Pain threshold assessment will be performed using a JTech Medical Commander Algometer. Measurements will be taken using a 1 cm² pressure probe, with the algometer held perpendicular to the measurement site. Assessments will be conducted at six points: 4 cm to the right and left of the umbilicus, 4 cm below these two points, 4 cm below the umbilicus, and the midpoint of the spinous processes of the S2-S4 vertebrae. Two measurements will be obtained from each point, with a 30-second rest interval between measurements. The average of the two readings will be calculated and recorded in lbs/cm². | Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| Analgesic Use | Analgesic use during menstruation will be recorded using a participant diary. Participants will be asked to report whether they used any analgesic medication for menstrual pain, the name of the medication, the number of doses taken, and the days of use during menstruation. Analgesic use will be reported as the total number of analgesic doses used during each menstrual cycle. Higher values indicate greater analgesic use and therefore a worse outcome. | Time Frame: Cycle 0, menstrual days 1-2; Cycle 1, menstrual days 1-2, approximately Week 4; Cycle 2, menstrual days 1-2, approximately Week 8. Each cycle is expected to last 28 +/- 7 days. |
| Cycle 1, menstrual days 1-2, approximately Week 4. Each cycle is expected to last 28 +/- 7 days. |
| 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. | From the estimated ovulation day of Cycle 0, calculated as cycle length minus 14 days, until Cycle 1 Day 1, approximately 14 days. Each cycle is expected to last 28 +/- 7 days. |