Multidisciplinary programme of care for women with endometriosis and its effect on chronic pelvic pain and quality of life-A Randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- 1. Assessment of Pain severity using Numerical pain rating scale NPRS (0-10) in both Intervention and Control arm.
研究概览
简要总结
RATIONALE OF THE STUDY: Endometriosis is a chronic, inammatory, estrogen-dependent disorder that is linked to pelvic pain, infertility, and a hampered quality of life. Typically, women with endometriosis are treated by a single physician. In this single-provider model of care, women frequently report lengthy diagnostic delays, unresolved pelvic pain, multiple laparoscopic surgeries, sequential consultations, and dissatisfaction with care overall. Multiple care team specialists with expertise in specic therapeutic areas treat patients with endometriosis and associated comorbidities in a coordinated, patient-centered manner. Novelty: The present study aims to study the eect of a multidisciplinary program of care on chronic pelvic pain and overall quality of life in women with endometriosis. There is a paucity of prospective randomized control trials. addressing this aspect of treatment, and there are no similar studies in the Indian population. OBJECTIVES- PRIMARY OBJECTIVES to study the eect of a multidisciplinary program of care on chronic pelvic pain and overall quality of life in women with endometriosis. . SECONDARY OBJECTIVES 1. To study the eect of a multidisciplinary program of care on hematological and biochemical parameters in women with endometriosis. 2. To perform next-generation sequencing analyses targeting novel variants of endometriosis in treatment-resistant patients. METHODS- Study design: open label A randomized controlled trial Study site- 1. Department of Obstetrics and Gynecology, AIIMS Rishikesh, in collaboration with the Department of Physical Medicine and Rehabilitation, the Department of Biochemistry, Intervention Arm: Multidisciplinary program of care along with standard of care treatment Control Arm: Standard of Care Treatment OUTCOMES - 1. Assessment of pain severity using the numerical pain rating scale NPRS (0–10) at 0, 6, and 12 weeks of the study in both the intervention and control arms. 2. Assessment of quality of life using the WHOQOL-Bref questionnaire at 0 and 12 weeks of the study in both the intervention and control arms 3. Assessment of hematological and biochemical parameters at 0 and 12 weeks of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 47.00 Year(s)（—）
- 性别
- Female
入选标准
- •Surgery or MRI confirmed Endometriosis with moderate to severe chronic pelvic pain with NPRS more than 5.
排除标准
- •(a)Not consenting for the study (b)Serious physical pain diseases (e.g., fibromyalgia, Crohn’s disease, Colitis Ulcerosa), (b) Severe psychiatric diagnosis, (c) Pregnancy or planned pregnancy during the study period, (d) Estimated lack of mental or physical surplus to enter into a psychological treatment or cultural barriers.
结局指标
主要结局
1. Assessment of Pain severity using Numerical pain rating scale NPRS (0-10) in both Intervention and Control arm.
时间窗: 1. At baseline , 6 and 12 weeks of the study in both Intervention and Control arm. | 2. At baseline and 12 weeks of the study in both Intervention and Control arm
2. Assessment of Quality of life using WHOQOL-Bref questionnaire at in both Intervention and Control arm
时间窗: 1. At baseline , 6 and 12 weeks of the study in both Intervention and Control arm. | 2. At baseline and 12 weeks of the study in both Intervention and Control arm
次要结局
- Assessment of Hematological & Biochemical parameters
研究者
Dr Amrita Gaurav
Department of Obstetrics and Gynaecology