Effect of Respiratory Exercises With Pelvic Floor Rehab on Dyspareunia & Autonomic Function in Women

NCT07078318 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-07-22

No results posted yet for this study

Summary

Background and Aim:

Dyspareunia, or pain during sexual intercourse, is a common component of female sexual dysfunction and may have multifactorial origins, including musculoskeletal and autonomic factors. While pelvic floor rehabilitation is an established treatment approach for musculoskeletal dyspareunia, it may not sufficiently address the autonomic dysregulation commonly observed in chronic pain conditions. The aim of this study is to investigate the effects of adding diaphragmatic breathing exercises and diaphragm manual therapy to standard pelvic floor rehabilitation on pain severity, pelvic floor function, and autonomic nervous system regulation in women diagnosed with musculoskeletal-origin dyspareunia.

Methods:

This randomized controlled clinical trial will be conducted between September 1, 2025, and December 1, 2025, at the Kurbaa Training and Consultation Center in Istanbul. A total of 45 participants aged 18-45 years who meet the inclusion criteria will be randomly assigned into three equal groups (n = 15):

Group I: Pelvic floor rehabilitation only

Group II: Pelvic floor rehabilitation + diaphragmatic breathing exercises

Group III: Pelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therapy

Interventions will be administered once per week for 8 weeks. Pre- and post-intervention assessments will include pain intensity (Visual Analog Scale), pelvic floor muscle function (ultrasonography), sexual function (Female Sexual Function Index), anxiety level (Beck Anxiety Inventory), and autonomic regulation (Heart Rate Variability using Elite HRV). Statistical analyses will be performed using SPSS with significance set at p \< 0.05.

Expected Contribution:

This study is expected to contribute to the development of more comprehensive treatment protocols for dyspareunia by integrating physical and neurophysiological rehabilitation components. It may also provide evidence supporting the role of autonomic regulation in improving treatment outcomes for female sexual pain disorders.

Conditions

  • Dyspareunia (Female Excluding Psychogenic)
  • Female Sexual Dysfunction (FSD)
  • Chronic Pelvic Pain

Interventions

OTHER

Pelvic floor rehabilitation

Participants in this group will receive standard pelvic floor rehabilitation. This includes education about pelvic floor anatomy and function, supervised pelvic floor muscle training (Kegel exercises), relaxation techniques, and manual release of trigger points if necessary. The aim is to improve muscle strength, coordination, and reduce pelvic floor hypertonicity contributing to dyspareunia.

OTHER

Diaphragmatic Breathing Exercises

In addition to the standard pelvic floor rehabilitation, participants in this group will practice diaphragmatic breathing exercises. These exercises focus on deep, slow nasal inhalation using the diaphragm, encouraging abdominal expansion while minimizing chest movement. Sessions are performed twice daily for 10 minutes. This technique is aimed at promoting parasympathetic activation, reducing anxiety, and improving autonomic regulation.

OTHER

Diaphragm Manual Therapy

an additional manual therapy intervention targeting the diaphragm. Diaphragm manual therapy involves hands-on techniques applied to the thoracic and abdominal regions to reduce fascial restrictions, improve diaphragmatic mobility, and support deeper, more effective breathing. The therapy is delivered for 15 minutes at the start of each weekly session by a trained physiotherapist.

Sponsors & Collaborators

  • Sakarya Applied Sciences University

    lead OTHER

Principal Investigators

  • Abdurrahim Yıldız, Assoc. Prof. · Sakarya Applied Sciences University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-07-01
Completion
2026-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078318 on ClinicalTrials.gov