About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Presence of neurological, gynecological, or urological pathologies causing pelvic pain (e.g., endometriosis, pelvic inflammatory disease)
Trial design
Parallel
Treatments tested in this trial
Pelvic floor rehabilitation
Other interventionParticipants 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.
Diaphragmatic Breathing Exercises
Other interventionIn 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.
Diaphragm Manual Therapy
Other interventionan 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.
Treatment groups
Trial outcomes
Primary outcomes
Pelvic Floor Muscle Function Measured by Ultrasonography (mm displacement)
Change in displacement of pelvic floor muscle during contraction, measured via transabdominal ultrasonography. Higher values indicate stronger muscle activity.
Female Sexual Function Index (FSFI) Total Score
FSFI is a validated 19-item questionnaire (Score range: 2-36), with higher scores indicating better sexual function.
Heart Rate Variability (HRV) Index Measured with Elite HRV
Time-domain and frequency-domain HRV parameters. Higher HRV indicates better autonomic balance.
Secondary outcomes
Pain Intensity During Intercourse Assessed by VAS (0-10 cm)
VAS line score from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Beck Anxiety Inventory (BAI) Total Score
BAI includes 21 items scored 0-3 each (Total Score: 0-63); higher scores indicate worse anxiety.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: