Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07263516

Pelvic Floor and Diaphragmatic Breathing Exercises for 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Primary Dysmenorrhea (PD) Agnosia Anxiety Disorders Behavior Behavioral Symptoms Depression Dysmenorrhea Dyssomnias Menstruation Disturbances Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Perceptual Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Gelişim University

Istanbul, Avcılar, 34310, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Diaphragmatic Breathing Exercises

Behavioral

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

Primary outcomes

  1. Pain intensity (Visual Analog Scale, VAS)

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

    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.

  2. Pain Threshold (Pressure Algometer)

    Time frame: 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 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.

  3. Menstrual Symptoms (Menstrual Symptom Scale - MSS)

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

    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

  4. Premenstrual Symptoms (PMS Scale)

    Time frame: One week before menstruation

    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.

Secondary outcomes

  1. Quality of Life (SF-36)

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

    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.

  2. Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

    Time frame: 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 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.

  3. Depression, Anxiety, and Stress (DASS-21)

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

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Registry information

Official study title

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

Acronym: PFDD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.