New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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
Investigators
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.)
Outcomes
Primary Outcomes
Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
Time Frame: at 3 months
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.
Secondary Outcomes
- Comparison of area of pain on the body pain schema, before/after patient care(at 3 months)
- number of painful crises(at 3 months)
- Evolution of overall pain: Visual Analogue Scale (VAS)(at 3 months)
- Comparison of results of the interview schedule(at 3 months)
- Evolution of the Role Emotional (RE) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of analgesics consumption(at 3 months)
- Evolution of the Vitality (VT) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of the Physical Function (PF) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of pain: Visual Analogue Scale (VAS)(at 3 months)
- Comparison of painful location on the body pain schema, before/after patient care(at 3 months)
- Evolution of the Social Function (SF) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of the Mental Health (MH) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of the General Health (GH) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evaluation of the patient compliance with group management sessions(at 3 months)
- Evolution of the Mental Component Score (MCS) of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of the Bodily Pain (BP) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of the Health Thinking (HT) score of the MOS SF36 score, before/after treatment(at 3 months)
- Evolution of the Role Physical (RP) score of the MOS SF36 score, before/after treatment(at 3 months)