Multidisciplinary care for women with endometriosis and pain
New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
This study tests a team-based approach to help women with severe endometriosis and pain improve their quality of life by focusing on both their physical and mental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT03993197 on ClinicalTrials.gov |
What this trial studies
This study evaluates a multidisciplinary approach to managing severe endometriosis, focusing on psychological and physical group management during the perioperative phase. It aims to assess the impact of this approach on the overall quality of life for patients suffering from debilitating pain associated with endometriosis. The study includes patients who have not responded adequately to previous medical or surgical treatments and emphasizes the importance of addressing both physical and psychological aspects of the condition.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with deep endometriosis and chronic pain who have not found relief through standard treatments.
Not a fit: Patients with social phobia, severe psychiatric disorders, or physical disabilities that prevent participation in group care may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with severe endometriosis by addressing both pain management and psychological well-being.
How similar studies have performed: While there is ongoing research in multidisciplinary approaches for endometriosis, this specific combination of psychological and physical group management is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>=18 years * Patients with deep endometriosis according to the CNGOF (collège national des Gynécologues et Obstétriciens Français) and/or chronic pain related to endometriosis according to doctor's evaluation and to the definitions of IASP (International Association for the Study of Pain) and HAS (French National Authority for Health) in treatment failure despite appropriate medical or surgical management of endometriosis * Patients with social security * Patients willing to come to all study visits * Patients who signed their informed consent Exclusion Criteria: * Patients unable to participate in group care: * Patients with social phobia assessed during the inclusion interview * Patients with psychiatric disorders of a psychotic nature: delirium, hallucination, incoherent thoughts * Patients with behavioral disorders of hetero-aggressive or self-aggressive type oPatients with a handicap that prevents them following the physical and psychological group sessions (speech disorders, hearing, visual or practical) * Pregnant women * Patients planning a change (stop, start) during the study of their psychological management in their current care path. * Patients planning a change (stop, start) during the study of their treatment by non-medicinal techniques (auriculo-acupuncture, relaxation and self-hypnosis, transcutaneous neurostimulation by TENS) * Patients suffering from other severe or chronic somatic diseases associated with endometriosis * Patients with cognitive disorders * Patients with analgesics addiction (psychoactive substances, morphine substances, etc.) * Patients protected by law (under guardianship / trusteeship) * Patients participating in another interventional research that may interfere with the protocol results
Where this trial is running
Lyon
- Croix Rousse Hospital — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Patricia Branche, MD — Hospices Civils de Lyon
- Study coordinator: Patricia Branche, MD
- Email: patricia.branche@chu-lyon.fr
- Phone: 472 072 581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.