Connective Tissue Massage and Music-Based Progressive Muscle Relaxation in Primary Dysmenorrhea
26 czerwca 2026 zaktualizowane przez: Raziye Şavkın, Pamukkale University
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
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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
36
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Denizli, Turcja (Türkiye)
- Rekrutacyjny
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation
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Kontakt:
- Raziye Şavkın, Assoc. Prof.
- Numer telefonu: +902582964253
- E-mail: raziyesavkin@hotmail.com
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Connective Tissue Massage Group
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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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.
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Eksperymentalny: Music-Based Progressive Muscle Relaxation Group
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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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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Brak interwencji: Control Group
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Pain Intensity
Ramy czasowe: 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.
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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.
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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.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Pain Catastrophizing Scale
Ramy czasowe: 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.
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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.
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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.
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Functional and Emotional Dysmenorrhea Scale
Ramy czasowe: 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.
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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.
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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.
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Menstrual Attitude Scale
Ramy czasowe: 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.
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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.
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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.
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Menstrual Symptom Scale
Ramy czasowe: 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.
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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.
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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.
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Pain Threshold
Ramy czasowe: 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.
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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.
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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.
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Analgesic Use
Ramy czasowe: 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.
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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.
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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.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Intervention Satisfaction
Ramy czasowe: Cycle 1, menstrual days 1-2, approximately Week 4. Each cycle is expected to last 28 +/- 7 days.
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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.
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Cycle 1, menstrual days 1-2, approximately Week 4. Each cycle is expected to last 28 +/- 7 days.
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Intervention Adherence
Ramy czasowe: 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.
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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.
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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.
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Współpracownicy i badacze
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Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
22 czerwca 2026
Zakończenie podstawowe (Szacowany)
30 października 2026
Ukończenie studiów (Szacowany)
15 listopada 2026
Daty rejestracji na studia
Pierwszy przesłany
21 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
15 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
26 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- E-60116787-020-776510
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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