Clinical trial NCT03993197: Endometriosis and Pain
Official title: New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Pain
group management
quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
timeFrame: at 3 months
Secondary outcomes:
measure: Evolution of pain: Visual Analogue Scale (VAS)
timeFrame: at 3 months
measure: Evolution of overall pain: Visual Analogue Scale (VAS)
timeFrame: at 3 months
measure: Comparison of painful location on the body pain schema, before/after patient care
timeFrame: at 3 months
measure: Comparison of area of pain on the body pain schema, before/after patient care
timeFrame: at 3 months
measure: Comparison of results of the interview schedule
timeFrame: at 3 months
measure: Evolution of analgesics consumption
timeFrame: at 3 months
measure: number of painful crises
timeFrame: at 3 months
measure: Evolution of the Vitality (VT) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Social Function (SF) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Mental Health (MH) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Role Emotional (RE) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Physical Function (PF) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Role Physical (RP) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Bodily Pain (BP) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the General Health (GH) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Health Thinking (HT) score of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evolution of the Mental Component Score (MCS) of the MOS SF36 score, before/after treatment
timeFrame: at 3 months
measure: Evaluation of the patient compliance with group management sessions
timeFrame: at 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix Rousse Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Patricia Branche, MD
role: PRINCIPAL_INVESTIGATOR
References: