Pelvic Floor and Diaphragmatic Breathing Exercises for Primary Dysmenorrhea

NCT ID: NCT07263516

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-30

Brief Summary

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This study investigates whether combining pelvic floor muscle exercises with diaphragmatic breathing exercises can reduce menstrual pain in women with primary dysmenorrhea. Forty participants will be randomly assigned to two groups: one performing both exercises, and the other performing only diaphragmatic breathing. The study will measure pain, menstrual symptoms, quality of life, and psychological well-being before and after the intervention.

Detailed Description

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This interventional study aims to investigate the combined effects of pelvic floor muscle exercises and diaphragmatic breathing exercises on primary dysmenorrhea in women. The study is designed based on a biopsychosocial model to explore both physical and psychological outcomes of the intervention.

A total of 40 participants will be recruited and randomly assigned to two groups. The intervention group will perform a program combining pelvic floor and diaphragmatic breathing exercises, while the control group will perform only diaphragmatic breathing exercises. The exercise program will be conducted over a specified period, with sessions scheduled regularly according to the study protocol.

Assessments will be conducted twice: prior to and after the menstrual period. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and pain threshold will be measured with a pressure algometer. Menstrual and premenstrual symptoms, quality of life, sleep quality, and psychological status, including depression, anxiety, and stress levels, will be assessed using validated scales such as the PMS Scale, SF-36, DASS-21, and PUKI.

This study is expected to provide scientific evidence for physiotherapy interventions in women's health and offer an alternative non-pharmacological approach for managing primary dysmenorrhea. By addressing both physical and psychological aspects, the exercise program may reduce pain, improve quality of life, and enhance overall well-being in participants.

Conditions

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Primary Dysmenorrhea (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to two parallel groups. The intervention group will perform a combined program of pelvic floor muscle and diaphragmatic breathing exercises, while the control group will perform only diaphragmatic breathing exercises. Both groups will be assessed at two time points: before and after the menstrual period.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study. No participants, care providers, investigators, or outcome assessors are blinded to group assignments.

Study Groups

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Arm 1: Intervention group → Pelvic floor + diaphragmatic breathing exercises

Participants will perform a combined program of pelvic floor muscle exercises and diaphragmatic breathing exercises. The exercises will be conducted according to the study protocol, with sessions scheduled regularly over the intervention period. Both physical and psychological outcomes will be assessed before and after the menstrual period.

Group Type EXPERIMENTAL

Pelvic Floor + Breathing Exercises

Intervention Type BEHAVIORAL

Participants will perform both pelvic floor and diaphragmatic breathing exercises according to the study protocol. Assessments will focus on pain, quality of life, and psychological measures.

Arm 2: Control group: Diaphragmatic breathing exercises

Participants will perform only diaphragmatic breathing exercises according to the study protocol. Assessments of pain, menstrual symptoms, quality of life, sleep quality, and psychological measures will be conducted before and after the menstrual period.

Group Type ACTIVE_COMPARATOR

Diaphragmatic Breathing Exercises

Intervention Type BEHAVIORAL

Participants will perform only diaphragmatic breathing exercises. Assessments will be conducted in the same manner.

Interventions

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Pelvic Floor + Breathing Exercises

Participants will perform both pelvic floor and diaphragmatic breathing exercises according to the study protocol. Assessments will focus on pain, quality of life, and psychological measures.

Intervention Type BEHAVIORAL

Diaphragmatic Breathing Exercises

Participants will perform only diaphragmatic breathing exercises. Assessments will be conducted in the same manner.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older
* Diagnosed with primary dysmenorrhea (PD)
* Having regular menstrual cycles for the past 6 months
* Willing to participate in the study

Exclusion Criteria

* Diagnosis of secondary dysmenorrhea
* Irregular menstrual cycles (less than 21 days or more than 35 days)
* History of childbirth or previous pregnancy
* Currently pregnant
* Presence of any neurological, systemic, or psychiatric chronic disease
* Regular use of medications in the past 6 months
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Gelisim University

OTHER

Sponsor Role lead

Responsible Party

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Irmak KARDEŞ

Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irmak KARDEŞ

Role: PRINCIPAL_INVESTIGATOR

Istanbul Gelişim University

Locations

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Istanbul Gelişim University

Istanbul, Avcılar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hüsniye Merve DEMİRER, PhD

Role: CONTACT

05437290967

Facility Contacts

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Irmak KARDEŞ

Role: primary

+905330307987

Hüsniye Merve DEMİRER, PhD

Role: backup

+905437290967

References

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Dixon JS, Bird HA. Reproducibility along a 10 cm vertical visual analogue scale. Ann Rheum Dis. 1981 Feb;40(1):87-9. doi: 10.1136/ard.40.1.87.

Reference Type RESULT
PMID: 7469530 (View on PubMed)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type RESULT
PMID: 2748771 (View on PubMed)

Brown TA, Chorpita BF, Korotitsch W, Barlow DH. Psychometric properties of the Depression Anxiety Stress Scales (DASS) in clinical samples. Behav Res Ther. 1997 Jan;35(1):79-89. doi: 10.1016/s0005-7967(96)00068-x.

Reference Type RESULT
PMID: 9009048 (View on PubMed)

ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.

Reference Type RESULT
PMID: 30461694 (View on PubMed)

Other Identifiers

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IstanbulGelisimU-FTR-IK-01

Identifier Type: -

Identifier Source: org_study_id

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