Endometriosis and Pain

NCT ID: NCT03993197

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2025-06-02

Brief Summary

Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Psychological repercussions are very important and underestimated. Patient care focuses most often on the "organ pathology treatment ".

This study proposes to evaluate a multidisciplinary patient care by insisting on anatomo-physiological pain management, psychological and bodily, in the perioperative phase.

The main objective is to evaluate benefit of psychological and corporal group management on the overall quality of life of patients with severe endometriosis in terms of endometriotic damage and/or functional and painful repercussions, requiring surgery, before or after this study

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients suffering from severe endometriosis and chronic pain

Patients suffering from severe endometriosis and chronic pain that have been identified during a gynecological consultation (individual or during a multidisciplinary team meetings) or during a pain consultation on the same site of the Croix-Rousse Hospital and having signed a consent form

Group Type: EXPERIMENTAL

Psychological and corporal group management

Intervention Type: BEHAVIORAL

After inclusion, patient will be divided into groups of 6 or 8 patients either in pre-operative or post-operative phase. Patient care will take place entirely in pre-operative or post-operative phase.

Each group will benefit of six one hour and a half sessions.

The frequency is established as follows:

• First week a session of Body Strategy ©
• Second week a psychological session with group of speech (Photolanguage ©).
• Third week is a break Then the cycle currently described is repeated, for a total of 6 alternate sessions

Interventions

Psychological and corporal group management

After inclusion, patient will be divided into groups of 6 or 8 patients either in pre-operative or post-operative phase. Patient care will take place entirely in pre-operative or post-operative phase.

Each group will benefit of six one hour and a half sessions.

The frequency is established as follows:

• First week a session of Body Strategy ©
• Second week a psychological session with group of speech (Photolanguage ©).
• Third week is a break Then the cycle currently described is repeated, for a total of 6 alternate sessions

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Branche, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Croix Rousse Hospital

Lyon, , France

Countries

France

Other Identifiers

2018-A02599-46

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0474

Identifier Type: -

Identifier Source: org_study_id