Primary Dysmenorrhea
Conditions
Keywords
Primary dysmenorrhea, Connective tissue massage, Progressive muscle relaxation training, Pain
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.
Interventions
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.
OTHERMusic-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 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.
Sponsors
Pamukkale University
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to group allocation. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Analgesic Use | 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 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. |
| 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. | 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 | 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed