Pelvic Floor and Diaphragmatic Breathing Exercises for Primary Dysmenorrhea (PFDD)

Effects of Combined Pelvic Floor and Diaphragmatic Breathing Exercises on Primary Dysmenorrhea

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Dysmenorrhea (PD)
• Intervention / Treatment: Behavioral: Pelvic Floor + Breathing Exercises; Behavioral: Diaphragmatic Breathing Exercises

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Avcılar
    • Istanbul, Avcılar, Turkey (Türkiye), 34310
      • İstanbul Gelisim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: Diaphragmatic Breathing Exercises; Participants will perform only diaphragmatic breathing exercises. Assessments will be conducted in the same manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (Visual Analog Scale, VAS)	Pain severity will be assessed using a 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain level, which will then be measured with a ruler to obtain a numerical value.	1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Pain Threshold (Pressure Algometer)	Pain threshold will be assessed at six anatomical points using a pressure algometer. Pressure is gradually increased until participants report pain. Two measurements per point are recorded, with the mean value calculated in lbs/cm².	1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Menstrual Symptoms (Menstrual Symptom Scale - MSS)	The severity of menstrual symptoms will be assessed using the Menstrual Symptom Scale (MSS), whose Turkish validity and reliability were established by Güvenç, Seven, and Akyüz (2014). The scale consists of 22 items, each rated on a 5-point Likert scale from 1 ("never") to 5 ("always"). Minimum possible total score: 22 points Maximum possible total score: 110 points	1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Premenstrual Symptoms (PMS Scale)	Premenstrual symptoms will be assessed using the 44-item PMS Scale, covering nine subscales such as depressive mood, anxiety, fatigue, irritability, pain, sleep, and appetite changes. The total score of the scale is obtained by summing the scores from all subscales, ranging from 44 to 220 points. Higher scores indicate a greater severity of premenstrual syndrome (PMS) symptoms.	One week before menstruation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (SF-36)	The Short Form-36 (SF-36) questionnaire evaluates physical and mental health across 8 subscales. Scores range from 0-100, with higher scores indicating better quality of life.	1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)	Sleep quality will be measured with the PSQI, a 24-item questionnaire assessing sleep duration, quality, disturbances, and daytime dysfunction. Total scores range from 0-21; higher scores indicate poorer sleep quality.	1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Depression, Anxiety, and Stress (DASS-21)	DASS-21 assesses levels of depression, anxiety, and stress across 21 items. Each subscale includes 7 items, rated on a 0-3 Likert scale. Higher scores indicate greater severity of symptoms.	1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).

Collaborators and Investigators

• Sponsor: Istanbul Gelisim University
• Investigators: Principal Investigator: Irmak KARDEŞ, İstanbul Gelisim University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain management; primary dysmenorrhea; Menstrual pain; Physiotherapy; Biopsychosocial model; Sleep quality; Randomized controlled trial (RCT); Exercise therapy; Pelvic floor exercises; Women's health; Non-pharmacological treatment; Depression, anxiety, stress; Diaphragmatic breathing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Behavioral Symptoms; Neurobehavioral Manifestations; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pelvic Pain; Perceptual Disorders; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Agnosia; Dysmenorrhea; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: IstanbulGelisimU-FTR-IK-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No