Endometriosis and Pain

NCT03993197 | Completed

• 2 other identifiers: 69HCL18_04742018-A02599-46
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Keywords

Endometriosis; Pain; group management; quality of life

Outcome Measures

Primary Outcomes (1)

• Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale

  The Physical Composite Score (PCS) is based on four physical dimensions of quality of life and involves 8 components (Physical Functioning, Role Physical, Bodily Pain,General Health, Vitality, Social Functioning,Mental Health and Emotional Role). The evolution of the PCS is measured between T0, start of care, and the end of care (at T0 + 3 months). The PCS score ranges from 0 to 100, a higher score being associated with a better quality of life.

  at 3 months

Secondary Outcomes (18)

• Evolution of pain: Visual Analogue Scale (VAS)

  at 3 months

• Evolution of overall pain: Visual Analogue Scale (VAS)

  at 3 months

• Comparison of painful location on the body pain schema, before/after patient care

  at 3 months

• Comparison of area of pain on the body pain schema, before/after patient care

  at 3 months

• Comparison of results of the interview schedule

  at 3 months

Study Arms (1)

Patients suffering from severe endometriosis and chronic pain

EXPERIMENTAL

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

Behavioral: Psychological and corporal group management

Interventions

Psychological and corporal group management 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

Patients suffering from severe endometriosis and chronic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients unable to participate in group care:
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix Rousse Hospital

Lyon, 69004, France

Location

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia Branche, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 20, 2019
• Study Start: December 11, 2019
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)