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

NCT07078318 | Not Yet Recruiting

• 1 other identifier: 1
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Week 8

• 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.

  Baseline and Week 8

• Heart Rate Variability (HRV) Index Measured with Elite HRV

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

  Baseline and Week 8

Secondary Outcomes (2)

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

  Baseline and Week 8

• Beck Anxiety Inventory (BAI) Total Score

  Baseline and Week 8

Study Arms (3)

Group I: Pelvic floor rehabilitation

EXPERIMENTAL

Pelvic floor rehabilitation only

Other: Pelvic floor rehabilitation; Other: Diaphragmatic Breathing Exercises; Other: Diaphragm Manual Therapy

Group II: Pelvic floor rehabilitation + diaphragmatic breathing exercises

EXPERIMENTAL

Pelvic floor rehabilitation + diaphragmatic breathing exercises

Other: Diaphragmatic Breathing Exercises; Other: Diaphragm Manual Therapy

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

EXPERIMENTAL

Pelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therapy

Other: Diaphragm Manual Therapy

Interventions

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.

Group I: Pelvic floor rehabilitation

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.

Group I: Pelvic floor rehabilitation; Group II: Pelvic floor rehabilitation + diaphragmatic breathing exercises

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.

Group I: Pelvic floor rehabilitation; Group II: Pelvic floor rehabilitation + diaphragmatic breathing exercises; Group III: Pelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therap

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya Applied Sciences University: lead

Related Publications (8)

• Nappi RE, Cucinella L, Martella S, Rossi M, Tiranini L, Martini E. Female sexual dysfunction (FSD): Prevalence and impact on quality of life (QoL). Maturitas. 2016 Dec;94:87-91. doi: 10.1016/j.maturitas.2016.09.013. Epub 2016 Sep 28.

  PMID: 27823751 RESULT

• Basson R, Wierman ME, van Lankveld J, Brotto L. Summary of the recommendations on sexual dysfunctions in women. J Sex Med. 2010 Jan;7(1 Pt 2):314-26. doi: 10.1111/j.1743-6109.2009.01617.x.

  PMID: 20092441 RESULT

• Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD), the International Society for the Study of Women's Sexual Health (ISSWSH), and the International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. Obstet Gynecol. 2016 Apr;127(4):745-751. doi: 10.1097/AOG.0000000000001359.

  PMID: 27008217 RESULT

• Buster JE. Managing female sexual dysfunction. Fertil Steril. 2013 Oct;100(4):905-15. doi: 10.1016/j.fertnstert.2013.08.026.

  PMID: 24074537 RESULT

• Berghmans B. Physiotherapy for pelvic pain and female sexual dysfunction: an untapped resource. Int Urogynecol J. 2018 May;29(5):631-638. doi: 10.1007/s00192-017-3536-8. Epub 2018 Jan 9.

  PMID: 29318334 RESULT

• Ege E, Akın B, Yaralı Arslan S, Bilgili N. (2010). Cinsel fonksiyon bozukluğu ve risk faktörleri. TÜBAV Bilim Dergisi, 3(2), 137-144.

  RESULT

• Oksuz E, Malhan S. Prevalence and risk factors for female sexual dysfunction in Turkish women. J Urol. 2006 Feb;175(2):654-8; discussion 658. doi: 10.1016/S0022-5347(05)00149-7.

  PMID: 16407018 RESULT

• Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008 Nov;112(5):970-8. doi: 10.1097/AOG.0b013e3181898cdb.

  PMID: 18978095 RESULT

MeSH Terms

Conditions

Dyspareunia; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Abdurrahim Yıldız, Assoc. Prof.

  Sakarya Applied Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdurrahim Yıldız, Assoc. Prof.

CONTACT

+905077516363; abdurrahimyildiz@subu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: 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).

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share