Perioperative Yoga Therapy and Endometriosis Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standard surgical management for endometriosis
Procedure/SurgeryParticipants 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.
Structured perioperative yogatherapy programme plus standard surgical management
Procedure/SurgeryParticipants 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.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Perioperative yogatherapy plus standard surgeryExperimental treatment 1 intervention
Group B: Standard surgery alone (control group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in endometriosis-related pain measured by the EHP-30 pain subscale
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.
Time frame
baseline3 Months6 monthes12 months after surgerySecondary outcomes
1
Endometriosis-specific and generic health-related quality of life
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.
Time frame
baseline3 months6 months12 months after surgery2
Pain characteristics, fatigue, sleep, emotional symptoms, sexual health, kinesiophobia, and daily functioning
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.
Time frame
baseline3 months6 months12 months after surgery. 14 days before each study visit3
Medication use, healthcare utilisation, hospitalisations, and work absenteeism
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.
Time frame
baseline3 months6 months12 months after surgery. 14 days before each study visit4
Adherence, acceptability, satisfaction, and autonomous use of the digital platform
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.
Time frame
During the 16 preoperative and 16 postoperative guided sessions3 to 9 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov
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