Connective Tissue Massage and Music-Based Progressive Muscle Relaxation in Primary Dysmenorrhea
26 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
36
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Denizli, Турция (Туркие)
- Рекрутинг
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation
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Контакт:
- Raziye Şavkın, Assoc. Prof.
- Номер телефона: +902582964253
- Электронная почта: raziyesavkin@hotmail.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Экспериментальный: 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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Без вмешательства: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain Intensity
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain Catastrophizing Scale
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Intervention Satisfaction
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
22 июня 2026 г.
Первичное завершение (Оцененный)
30 октября 2026 г.
Завершение исследования (Оцененный)
15 ноября 2026 г.
Даты регистрации исследования
Первый отправленный
21 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
9 июня 2026 г.
Первый опубликованный (Действительный)
15 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
30 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- E-60116787-020-776510
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .