Pelvic Floor and Diaphragmatic Breathing Exercises for Primary Dysmenorrhea

NCT07263516 | Enrolling By Invitation

• 1 other identifier: IstanbulGelisimU-FTR-IK-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea (PD)

Keywords

primary dysmenorrhea; Menstrual pain; Pelvic floor exercises; Diaphragmatic breathing; Physiotherapy; Pain management; Exercise therapy; Biopsychosocial model; Depression, anxiety, stress; Sleep quality; Non-pharmacological treatment; Randomized controlled trial (RCT); Women's health

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Quality of Life (SF-36)

  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)

  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)

  1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).

Study Arms (2)

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

EXPERIMENTAL

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

Arm 2: Control group: Diaphragmatic breathing exercises

ACTIVE COMPARATOR

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

Interventions

Pelvic Floor + Breathing Exercises 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 1: Intervention group → Pelvic floor + diaphragmatic breathing exercises

Diaphragmatic Breathing Exercises BEHAVIORAL

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

Arm 2: Control group: Diaphragmatic breathing exercises

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Only individuals who identify as female and have a uterus are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Gelisim University: lead

Study Sites (1)

Istanbul Gelişim University

Istanbul, Avcılar, 34310, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 7469530 RESULT

• 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.

  PMID: 2748771 RESULT

• 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.

  PMID: 9009048 RESULT

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

  PMID: 30461694 RESULT

MeSH Terms

Conditions

Dysmenorrhea; Agnosia; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Irmak KARDEŞ

  Istanbul Gelişim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, investigators, or outcome assessors are blinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 4, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)