Connective Tissue Massage and Progressive Relaxation in Primary Dysmenorrhea
9. Juni 2026 aktualisiert von: Raziye Şavkın, Pamukkale University
The Effectiveness of Connective Tissue Massage and Music-Based Progressive Muscle Relaxation for Primary Dysmenorrhea
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, pain threshold, analgesic use, and menstruation-related symptoms in women with primary dysmenorrhea.
Participants will be randomly assigned to CTM, music-based PMRT, or control groups.
Interventions will be applied during the 1st and 2nd menstrual cycles following the baseline assessment.
No intervention will be applied between the 2nd and 3rd menstrual cycles, and follow-up assessments will be conducted during the 3rd cycle.
Outcomes including pain severity, pain threshold, menstrual symptoms, attitudes toward menstruation, functional and emotional impact, and pain catastrophizing will be evaluated across menstrual cycles.
Participant satisfaction and adherence to the interventions will also be assessed.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
36
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Kontrollgruppe
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Experimental: Connective Tissue Massage Group
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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 from the estimated ovulation day (cycle length minus 14 days) until the onset of the next menstrual period.
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Experimental: Music-Based Progressive Muscle Relaxation Training Group
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain Intensity
Zeitfenster: At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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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 pain intensity experienced at its worst 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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At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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Pain Threshold
Zeitfenster: At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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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 different points: 4 cm to the right and left of the umbilicus (points 1 and 2), 4 cm below these two points (points 3 and 5), 4 cm below the umbilicus (point 4), and the midpoint of the spinous processes of the S2-S4 vertebrae (point 6).
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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At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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Menstrual Symptom Scale
Zeitfenster: At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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The Menstrual Symptom Scale was 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: items 1-13 represent the "Negative Effects/Somatic Complaints" subscale, items 14-19 represent the "Menstrual Pain Symptoms" subscale, and items 20-22 represent the "Coping Strategies" subscale.
An increase in the mean score indicates a higher severity of menstrual symptoms within the corresponding subscale.
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At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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Menstrual Attitude Scale
Zeitfenster: At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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The scale is based on the assumption that expectations regarding physiological and emotional symptoms before or during menstruation may influence behaviors during this period.
It consists of a total of 33 items across five categories: menstruation as a debilitating phenomenon (12 items), menstruation as a disturbing phenomenon (6 items), menstruation as a natural phenomenon (5 items), anticipation/perception of menstruation (5 items), and denial of the effects of menstruation (7 items).
Each item is rated on a five-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Higher scores on the scale indicate a more positive attitude toward menstruation.
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At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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Functional and Emotional Dysmenorrhea Scale
Zeitfenster: At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
|
Functional and Emotional Dysmenorrhea Scale is a Likert-type instrument used to assess dysmenorrhea in terms of functional and emotional aspects.
It consists of 14 items and 2 subscales.
Higher scores indicate a greater level of functional and emotional impact of dysmenorrhea on individuals.
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At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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Pain Catastrophizing Scale
Zeitfenster: At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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The Pain Catastrophizing Scale will be used to assess catastrophizing related to menstrual pain during the last menstrual period.
The scale consists of 13 items and 3 subscales (helplessness, magnification, and rumination).
Participants will be asked to rate the extent to which they experienced each of the 13 thoughts or feelings during menstrual pain on a 5-point scale ranging from 0 (not at all) to 4 (always).
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At baseline, immediately post-intervention (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period), and during the subsequent menstrual cycle follow-up.
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Intervention Satisfaction
Zeitfenster: After the intervention period (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period).
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Patients' satisfaction with the Connective Tissue Massage or Music-Based Progressive Muscle Relaxation Training interventions will be assessed using a 10-cm Visual Analog Scale (VAS) through two questions.
Q1: How satisfied were you with the overall treatment you received?
(0: Not at all satisfied - 10: Extremely satisfied) Q2: Would you recommend this treatment and/or advice to someone you know who suffers from menstrual pain?
(0: Definitely would not recommend - 10: Definitely would recommend)
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After the intervention period (the intervention period extending from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period).
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Intervention Adherence
Zeitfenster: During the intervention period (from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period).
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Participants' adherence to Connective Tissue Manipulation sessions will be recorded by the researcher who administers the intervention.
Participants will be asked to record their Music-Based Progressive Muscle Relaxation Training sessions in a relaxation diary.
Adherence will be calculated as the percentage of completed sessions relative to the planned number of sessions.
Compliance will be classified as good (≥80%), moderate (50-79%), or low (<50%) adherence.
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During the intervention period (from the estimated ovulation day [cycle length minus 14 days] until the onset of the subsequent menstrual period).
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Mitarbeiter und Ermittler
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. Juni 2026
Primärer Abschluss (Geschätzt)
1. März 2027
Studienabschluss (Geschätzt)
1. Juni 2028
Studienanmeldedaten
Zuerst eingereicht
21. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Juni 2026
Zuerst gepostet (Tatsächlich)
15. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- E-60116787-020-776510
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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