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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07078318
Acronym
Dyspareunia
Enrollment
45
Registered
2025-07-22
Start date
2025-09-01
Completion date
2026-12-01
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Dyspareunia, Pelvic Floor Rehab, Manual Therapy, Autonomic Regulation, Sexual Dysfunction

Brief 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.

Detailed description

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.

Interventions

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.

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.

OTHERDiaphragm 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

Sakarya Applied Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic Floor Muscle Function Measured by Ultrasonography (mm displacement)Baseline and Week 8Change in displacement of pelvic floor muscle during contraction, measured via transabdominal ultrasonography. Higher values indicate stronger muscle activity.
Female Sexual Function Index (FSFI) Total ScoreBaseline and Week 8FSFI 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 HRVBaseline and Week 8Time-domain and frequency-domain HRV parameters. Higher HRV indicates better autonomic balance.

Secondary

MeasureTime frameDescription
Pain Intensity During Intercourse Assessed by VAS (0-10 cm)Baseline and Week 8VAS line score from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Beck Anxiety Inventory (BAI) Total ScoreBaseline and Week 8BAI includes 21 items scored 0-3 each (Total Score: 0-63); higher scores indicate worse anxiety.

Contacts

Primary ContactAbdurrahim Yıldız, Assoc. Prof.
abdurrahimyildiz@subu.edu.tr+905077516363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026