AzTrials
AzTrials

Dyspareunia (Female Excluding Psychogenic)DyspareuniaNCT07078318

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

A study testing Pelvic floor rehabilitation, Diaphragmatic Breathing Exercises and Diaphragm Manual Therapy in people with Dyspareunia (Female Excluding Psychogenic) and Female Sexual Dysfunction (FSD), run by Sakarya Applied Sciences University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Pelvic floor rehabilitation, Diaphragmatic Breathing Exercises and Diaphragm Manual Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Abdurrahim Yıldız, Assoc. Prof. contact

+905077516363

abdurrahimyildiz@subu.edu.tr

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Pelvic floor rehabilitation, Diaphragmatic Breathing Exercises, Diaphragm Manual Therapy
Keywords
Dyspareunia, Pelvic Floor Rehab, Manual Therapy, Autonomic Regulation, Sexual Dysfunction
Medical subject headings
Dyspareunia, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic floor rehabilitationOther

    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 ExercisesOther

    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 TherapyOther

    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.

Study groups in NCT07078318
Study groupRoleWhat they receive
Group I: Pelvic floor rehabilitationExperimentalPelvic floor rehabilitation only
Receives: Other: Pelvic floor rehabilitation; Other: Diaphragmatic Breathing Exercises; Other: Diaphragm Manual Therapy
Group II: Pelvic floor rehabilitation + diaphragmatic breathing exercisesExperimentalPelvic floor rehabilitation + diaphragmatic breathing exercises
Receives: Other: Diaphragmatic Breathing Exercises; Other: Diaphragm Manual Therapy
Group III: Pelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therapExperimentalPelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therapy
Receives: Other: Diaphragm Manual Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 8

  2. 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.

    Measured: Baseline and Week 8

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

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

    Measured: Baseline and Week 8

Secondary outcomes (2)
  1. 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.

    Measured: Baseline and Week 8

  2. Beck Anxiety Inventory (BAI) Total Score

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

    Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078318
Sponsor's protocol ID
1
Acronym
Dyspareunia
Status last verified
Jul 2025
First submitted
3 Jul 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be shared after publication upon reasonable request.

Publications

  • 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.

    PubMed 27823751
  • 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.

    PubMed 20092441
  • 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.

    PubMed 27008217
  • Buster JE. Managing female sexual dysfunction. Fertil Steril. 2013 Oct;100(4):905-15. doi: 10.1016/j.fertnstert.2013.08.026.

    PubMed 24074537
  • 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.

    PubMed 29318334
  • Ege E, Akın B, Yaralı Arslan S, Bilgili N. (2010). Cinsel fonksiyon bozukluğu ve risk faktörleri. TÜBAV Bilim Dergisi, 3(2), 137-144.

  • 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.

    PubMed 16407018
  • 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.

    PubMed 18978095

Questions about this trial

What is this clinical trial studying?

A study testing Pelvic floor rehabilitation, Diaphragmatic Breathing Exercises and Diaphragm Manual Therapy in people with Dyspareunia (Female Excluding Psychogenic) and Female Sexual Dysfunction (FSD), run by Sakarya Applied Sciences University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdurrahim Yıldız, Assoc. Prof. (+905077516363, abdurrahimyildiz@subu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic Floor Muscle Function Measured by Ultrasonography (mm displacement) (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078318, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in