Perioperative Yoga Therapy and Endometriosis Surgery

NCT07765680 | Not Yet Recruiting

• 1 other identifier: 2024_0326
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis; Chronic Pain; Impairment of Quality of Life

Keywords

Endometriosis; chronic pain; yogatherapy; surgery

Outcome Measures

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.

  baseline3 Months6 monthes12 months after surgery

Secondary Outcomes (4)

• 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

Study Arms (2)

Perioperative yogatherapy plus standard surgery

EXPERIMENTAL

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.

Procedure: Structured perioperative yogatherapy programme plus standard surgical management

Standard surgery alone (control group)

ACTIVE COMPARATOR

Standard surgical management for endometriosis

Procedure: Standard surgical management for endometriosis

Interventions

Standard surgical management for endometriosis PROCEDURE

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.

Standard surgery alone (control group)

Structured perioperative yogatherapy programme plus standard surgical management PROCEDURE

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.

Perioperative yogatherapy plus standard surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: study on endometriosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Endometriosis; Chronic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08