The Effectiveness of Yoga Therapy on Chronic Pain, Endometriosis Symptoms and Quality of Life Following Surgery for Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Change in endometriosis-related pain measured by the EHP-30 pain subscale
研究概览
简要总结
YOGENDOCHIR is a multicentre, prospective, randomised, controlled, parallel-group study involving 188 adult women scheduled to undergo surgery for endometriosis.
The study compares standard surgical management alone with the same management combined with a structured perioperative yoga therapy programme comprising 32 guided sessions (16 before and 16 after surgery), supplemented by a secure digital platform supporting independent practice and adherence monitoring.
The primary objective is to assess the effect of yoga therapy on endometriosis-related pain, as measured by the pain subscale of the Endometriosis Health Profile-30 (EHP-30). Participants are assessed before surgery and at 3, 6, and 12 months after the procedure.
Secondary outcomes include quality of life, pain characteristics, fatigue, sleep, anxiety and depressive symptoms, sexual health, kinesiophobia, activities of daily living, medication use, healthcare utilisation, absenteeism, adherence, satisfaction, and the participants' ability to use the platform independently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult woman (18 years or older) covered by a social health insurance scheme.
- •Surgery for endometriosis is indicated.
- •No assisted reproductive technology (ART) protocol planned within 6 months after surgery.
- •No chronic pain attributable to another disease or condition.
- •No yoga practice outside the study during participation.
排除标准
- 未提供
研究组 & 干预措施
Standard surgery alone (control group)
Standard surgical management for endometriosis
干预措施: Standard surgical management for endometriosis (Procedure)
Perioperative yogatherapy plus standard surgery
Participants undergo the indicated surgery for endometriosis and receive 32 live, guided yoga therapy sessions: 16 sessions during the 2 months before surgery and 16 sessions during the 3 months after surgery. Sessions are delivered by healthcare professionals trained in yoga therapy and combine adapted postures, breathing techniques, and meditative practices. A secure digital platform provides videos, audio materials, questionnaires, support for independent practice, and pseudonymised monitoring of session opening, initiation, interruption, completion, validation, frequency, and regularity.
干预措施: Structured perioperative yogatherapy programme plus standard surgical management (Procedure)
结局指标
主要结局
Change in endometriosis-related pain measured by the EHP-30 pain subscale
时间窗: baseline3 Months6 monthes12 months after surgery
Between-group difference in change from the preoperative baseline in the pain subscale of the Endometriosis Health Profile-30 (EHP-30), comparing perioperative yoga therapy plus standard surgery with standard surgery alone. The sample-size calculation is based on detecting an additional clinically relevant 11-point reduction in the EHP-30 pain subscore.
次要结局
- Endometriosis-specific and generic health-related quality of life(baseline3 months6 months12 months after surgery)
- Pain characteristics, fatigue, sleep, emotional symptoms, sexual health, kinesiophobia, and daily functioning(baseline3 months6 months12 months after surgery. 14 days before each study visit)
- Medication use, healthcare utilisation, hospitalisations, and work absenteeism(baseline3 months6 months12 months after surgery. 14 days before each study visit)
- Adherence, acceptability, satisfaction, and autonomous use of the digital platform(During the 16 preoperative and 16 postoperative guided sessions3 to 9 months after surgery)