Connective Tissue Massage and Music-Based Progressive Muscle Relaxation in Primary Dysmenorrhea

NCT07647276 | Recruiting

• 1 other identifier: E-60116787-020-776510
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

Primary dysmenorrhea; Connective tissue massage; Progressive muscle relaxation training; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Pain Catastrophizing Scale

  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

  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

  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

  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

  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.

Other Outcomes (2)

• Intervention Satisfaction

  Cycle 1, menstrual days 1-2, approximately Week 4. Each cycle is expected to last 28 +/- 7 days.

• Intervention Adherence

  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.

Study Arms (3)

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.

Other: Connective Tissue Massage

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.

Other: Music-based Progressive Muscle Relaxation

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.

Interventions

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.

Music-Based Progressive Muscle Relaxation Group

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.

Connective Tissue Massage Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Pamukkale University, Faculty of Physiotherapy and Rehabilitation

Denizli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 15, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

TU (1)