NCT Number: NCT07765680
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University Hospital, Lille
Other
The Effectiveness of Yoga Therapy on Chronic Pain, Endometriosis Symptoms and Quality of Life Following Surgery for Endometriosis
Acronym: YOGENDOCHIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07501182
Chronic Pain, Endometriosis
View Trial DetailsNCT06212349
Adherence Interventions, Behavior
Valencia, Spain
View Trial DetailsNCT07424859
Chronic Pain, Dysmenorrhea
São Paulo, Brazil
View Trial DetailsNCT06153303
Chronic Pain, Endometriosis
Lund, Skåne County, Sweden
View Trial Details