Connective Tissue Massage and Music-Based Progressive Muscle Relaxation in Primary Dysmenorrhea
26 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
36
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Denizli, Turquia (Türkiye)
- Recrutamento
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation
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Contato:
- Raziye Şavkın, Assoc. Prof.
- Número de telefone: +902582964253
- E-mail: raziyesavkin@hotmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Pain Intensity
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain Catastrophizing Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intervention Satisfaction
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
22 de junho de 2026
Conclusão Primária (Estimado)
30 de outubro de 2026
Conclusão do estudo (Estimado)
15 de novembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2026
Primeira postagem (Real)
15 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- E-60116787-020-776510
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