The Effect of Respiratory Exercises Given in Addition to Pelvic Floor Rehabilitation on Dyspareunia and Autonomic Nervous System in Women With Musculoskeletal Dyspareunia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Pelvic Floor Muscle Function Measured by Ultrasonography (mm displacement)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Pelvic Floor Muscle Function Measured by Ultrasonography (mm displacement)
时间窗: Baseline and Week 8
Change in displacement of pelvic floor muscle during contraction, measured via transabdominal ultrasonography. Higher values indicate stronger muscle activity.
Heart Rate Variability (HRV) Index Measured with Elite HRV
时间窗: Baseline and Week 8
Time-domain and frequency-domain HRV parameters. Higher HRV indicates better autonomic balance.
Female Sexual Function Index (FSFI) Total Score
时间窗: Baseline and Week 8
FSFI is a validated 19-item questionnaire (Score range: 2-36), with higher scores indicating better sexual function.
次要结局
- Pain Intensity During Intercourse Assessed by VAS (0-10 cm)(Baseline and Week 8)
- Beck Anxiety Inventory (BAI) Total Score(Baseline and Week 8)
研究者
Abdurrahim Yıldız
Assoc. Prof.
Sakarya Applied Sciences University