Chronic Pain, Endometriosis, Impairment of Quality of Life
Conditions
Keywords
Endometriosis, chronic pain, yogatherapy, surgery
Brief summary
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.
Interventions
PROCEDUREStandard surgical management for endometriosis
Participants undergo the indicated surgery for endometriosis and receive standard perioperative and follow-up care, without study yoga therapy sessions. They complete the same scheduled clinical and patient-reported assessments as the intervention group.
PROCEDUREStructured perioperative yogatherapy programme plus standard surgical management
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.
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in endometriosis-related pain measured by the EHP-30 pain subscale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometriosis-specific and generic health-related quality of life | baseline3 months6 months12 months after surgery | Changes in the non-pain EHP-30 domains (control and powerlessness, emotional well-being, social support, and self-esteem) and in EQ-5D-5L dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A subjective quality-of-life assessment is also recorded in the self-care book. |
| Pain characteristics, fatigue, sleep, emotional symptoms, sexual health, kinesiophobia, and daily functioning | baseline3 months6 months12 months after surgery. 14 days before each study visit | Pain intensity and sensory/affective characteristics are assessed using a 0-10 visual analogue scale and the short-form Saint-Antoine Pain Questionnaire. Anxiety and depressive symptoms are assessed with the Hospital Anxiety and Depression Scale. General health observations document sleep, fatigue, urinary and digestive symptoms, emotions, and bodily sensations. Sexual health, fear of movement, and limitations in activities of daily living are also evaluated. |
| Medication use, healthcare utilisation, hospitalisations, and work absenteeism | baseline3 months6 months12 months after surgery. 14 days before each study visit | Between-group comparison of medication use, healthcare contacts and consultations, hospital admissions, sick leave, and absence from work over the 12-month follow-up period. |
| Adherence, acceptability, satisfaction, and autonomous use of the digital platform | During the 16 preoperative and 16 postoperative guided sessions3 to 9 months after surgery | Attendance at guided sessions, satisfaction with the programme, autonomy, and appropriation of the tools are evaluated. Pseudonymised platform metrics include opening, initiation, interruption, completion and validation of sessions, together with the frequency and regularity of independent practice. |
Outcome results
None listed