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

Official title

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

Overview

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.

Interventions

• Other Connective Tissue Massage
  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.
• Other Music-based Progressive Muscle Relaxation
  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 durin

Primary outcome measures

• Pain Intensity [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.]

Secondary outcome measures (6)

• Pain Catastrophizing Scale [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.]
• Functional and Emotional Dysmenorrhea Scale [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.]
• Menstrual Attitude Scale [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.]
• Menstrual Symptom Scale [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.]
• Pain Threshold [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.]
• Analgesic Use [Time frame: 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.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Pamukkale University, Faculty of Physiotherapy and Rehabilitation — Denizli

Identifiers

NCT: NCT07647276 · E-60116787-020-776510

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗