New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evolution of Physical Component Score (PCS) assessed by the Medical Outcome Study Short Form -36 (MOS SF 36) scale
时间窗: 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.
次要结局
- 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)