Endometriosis and Pain (EndoDOL)

Civil Hospices of Lyon

Status: Completed

Conditions: Endometriosis

Treatments: Behavioral: Psychological and corporal group management

Study type: Interventional

Funder types: Other

Identifiers

NCT03993197

2018-A02599-46 (Other Identifier)

69HCL18_0474

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Patients suffering from severe endometriosis and chronic pain

Experimental group

Description:

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

Treatment:

Behavioral: Psychological and corporal group management