An interventional study of Pelvic floor rehabilitation and Diaphragmatic Breathing Exercises in Dyspareunia (Female Excluding Psychogenic), Female Sexual Dysfunction (FSD) and Chronic Pelvic Pain, sponsored by Sakarya Applied Sciences University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Sakarya Applied Sciences University · Not applicable, Interventional, and Treatment
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.
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.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 45 is below the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Sakarya Applied Sciences University is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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:
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
> 35, which may interfere with ultrasonographic assessment
Non-compliance risk, such as irregular attendance or language barriers
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pelvic floor rehabilitation only
Other: Pelvic floor rehabilitation · Other: Diaphragmatic Breathing Exercises · Other: Diaphragm Manual Therapy
Pelvic floor rehabilitation + diaphragmatic breathing exercises
Other: Diaphragmatic Breathing Exercises · Other: Diaphragm Manual Therapy
Pelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therapy
Other: Diaphragm Manual Therapy
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 8
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.
Time frame: Baseline and Week 8
Beck Anxiety Inventory (BAI) Total Score
BAI includes 21 items scored 0-3 each (Total Score: 0-63); higher scores indicate worse anxiety.
Time frame: Baseline and Week 8
No study locations are listed for this record.
Plan to share: Yes — Individual participant data (IPD) will be shared after publication upon reasonable request.
Start is estimated for Sep 2025; primary completion for Jul 2026, 10 months later.
Of 51 non-industry interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 10 months is below that.
Counting every sponsor, half of 59 studies reached it within 33 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Sakarya Applied Sciences University