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NCT Number: NCT07078318

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female participants aged between 18 and 45 years

Experiencing dyspareunia of musculoskeletal origin for at least 6 months

In a stable sexual relationship and sexually active

Willing and able to attend weekly treatment sessions for 8 weeks

Able to provide informed consent

No pelvic surgery within the last 6 months

Normal cognitive function and ability to follow instructions

Baseline FSFI score indicating sexual dysfunction (e.g., ≤ 26.55)

Exclusion criteria

  • Presence of neurological, gynecological, or urological pathologies causing pelvic pain (e.g., endometriosis, pelvic inflammatory disease)

Pregnancy or postpartum period within the last 6 months

Diagnosed psychiatric disorders (e.g., major depression, psychosis)

Use of medications that affect autonomic nervous system function (e.g., beta-blockers, antidepressants)

History of pelvic radiation, cancer, or pelvic trauma

Participation in other rehabilitation or psychotherapy programs during the study period

Inability to tolerate manual therapy or perform breathing exercises

BMI > 35, which may interfere with ultrasonographic assessment

Non-compliance risk, such as irregular attendance or language barriers

Treatment and study plan

Pelvic floor rehabilitation

Other

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.

Diaphragmatic breathing exercises

Other

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.

Diaphragm Manual Therapy

Other

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.

Primary outcomes

  1. Pelvic Floor Muscle Function Measured by Ultrasonography (mm displacement)

    Time frame: Baseline and Week 8

    Change in displacement of pelvic floor muscle during contraction, measured via transabdominal ultrasonography. Higher values indicate stronger muscle activity.

  2. Female Sexual Function Index (FSFI) Total Score

    Time frame: Baseline and Week 8

    FSFI is a validated 19-item questionnaire (Score range: 2-36), with higher scores indicating better sexual function.

  3. Heart Rate Variability (HRV) Index Measured with Elite HRV

    Time frame: Baseline and Week 8

    Time-domain and frequency-domain HRV parameters. Higher HRV indicates better autonomic balance.

Secondary outcomes

  1. Pain Intensity During Intercourse Assessed by VAS (0-10 cm)

    Time frame: Baseline and Week 8

    VAS line score from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

  2. Beck Anxiety Inventory (BAI) Total Score

    Time frame: Baseline and Week 8

    BAI includes 21 items scored 0-3 each (Total Score: 0-63); higher scores indicate worse anxiety.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdurrahim Yıldız, Assoc. Prof.

CONTACT

[email protected]

+905077516363

Sponsors and collaborators

Lead sponsor

Sakarya Applied Sciences University

Other

Registry information

Official study title

The Effect of Respiratory Exercises Given in Addition to Pelvic Floor Rehabilitation on Dyspareunia and Autonomic Nervous System in Women With Musculoskeletal Dyspareunia

Acronym: Dyspareunia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

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.

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