Effectiveness of a Multifaceted Behavioural Economics-Based Intervention for Reducing Pain and Anxiety, Improving Productivity and Quality of Life among Women with Endometriosis: A Randomized Controlled Trial in a Tertiary Health Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- i.Pain scores and categorization of women into mild, moderate, and severe pain levels.
研究概览
简要总结
Endometriosis is a chronic and often underdiagnosed condition that affects many women of reproductive age, leading to severe pain, anxiety, reduced productivity, and poor quality of life. Its complex symptoms and psychological burden call for more comprehensive and tailored management approaches. This study aims to develop and evaluate a multifaceted behavioural economics-based intervention that combines mindfulness-based stress reduction, physical activity, peer support, couple counselling, and gratitude journaling to address the physical, emotional, and social challenges faced by women with endometriosis.
A systematic review of existing literature on behavioural economics interventions in healthcare, focusing on endometriosis management, will be conducted. Key components and strategies will be identified and evaluated based on their effectiveness, feasibility, and impact on patient outcomes. Data will be synthesized from randomized controlled trials, observational studies, and expert opinions published in peer-reviewed and indexed journals to inform the final intervention framework.
A cross-sectional survey will be conducted for the second objective to collect data on pain, anxiety, productivity, quality of life, and the health profile of women with endometriosis. Standardized questionnaires and validated scales (e.g., Numeric Pain scale, GAD 7, EQ 5D-5L) will be used to gather self-reported data. Descriptive and inferential statistics will be applied to analyze the factors contributing to health outcomes.
For the third objective, a multifaceted behavioural economics-based intervention will be developed, integrating techniques such as nudging, anchoring, and motivation. The intervention will be pilot-tested with a small group of women with endometriosis to assess feasibility, acceptability, and preliminary effects on pain, anxiety, productivity, and quality of life.
A randomized controlled trial (RCT) will then be conducted with two groups: an intervention group receiving the standard care plus the behavioural economics-based intervention, and a control group receiving only the standard care. The trial will assess the impact of the intervention on pain, anxiety, productivity, quality of life, and the endometriosis health profile. Pre and post-intervention data will be collected and analyzed using the Generalized Estimating Equations (GEE) to determine effectiveness.
An economic evaluation will be conducted alongside a one-year RCT evaluating the multifaceted behavioural intervention for the last objective. A cost-effectiveness analysis (CEA) will be performed from a limited societal and healthcare perspective. Costs associated with the intervention (e.g., development, implementation) and outcomes (e.g., reduction in pain and anxiety scores) will be measured.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18 to 40 years with endometriosis.
- •Confirmed diagnosis- Women aged 18 to 40 years diagnosed by a physician with mild to severe endometriosis with endometrioma less than 6 cm, confirmed through laparoscopy, imaging such as ultrasound, MRI, or symptom history with pain for a minimum of 6 months, will be included in the study.
- •Symptoms of endometriosis- Women aged 18 to 40 years with a confirmed diagnosis of endometriosis, experiencing symptoms such as pelvic pain, dysmenorrhea, dyspareunia, dysuria, and bladder or bowel dysfunction that negatively impact productivity and quality of life, will be included in the study.
- •Women undergoing Hormonal Replacement Therapy (HRT) or recommended gynecological treatment for endometriosis will be included in the study.
- •Literacy and ability to self-report symptoms/outcomes- Women who can read and write with comprehension in Hindi, English, or Punjabi and can effectively communicate their symptoms and the impact of interventions through questionnaires and other assessment tools will be included.
- •Women who have access to a smartphone, desktop, laptop, or tablet with access to the internet.
- •Willingness to participate in the intervention and provide written consent- Women who are willing to participate and provide written informed consent to participate in the study.
排除标准
- •Women with severe psychological conditions (e.g., active psychosis, depression) will be excluded.
- •Women with severe endometriosis requiring immediate surgical intervention will be excluded from the study.
- •Women with endometriosis who refuse to take the recommended gynaecological treatment (hormonal replacement therapy) and behavioural intervention.
- •Women who are recommended or undergoing Assisted Reproductive Technology (ART).
- •Women having any other severe medical condition (such as carcinoma, etc.) or those who have undergone surgical intervention for endometriosis or any other illness within the past year will be excluded.
结局指标
主要结局
i.Pain scores and categorization of women into mild, moderate, and severe pain levels.
时间窗: The study outcomes will be assessed at the following time points | A) Baseline (before starting the intervention) | B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention) | C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention.
ii.Anxiety scores and categorization of women into minimal, mild, moderate, and severe anxiety levels.
时间窗: The study outcomes will be assessed at the following time points | A) Baseline (before starting the intervention) | B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention) | C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention.
iii.Percent work time lost (absenteeism), Percent productivity impairment while working (presenteeism), and Total activity impairment.
时间窗: The study outcomes will be assessed at the following time points | A) Baseline (before starting the intervention) | B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention) | C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention.
iv.Utility scores (EQ-5D-5L) and EQ-VAS score for self-reported health status.
时间窗: The study outcomes will be assessed at the following time points | A) Baseline (before starting the intervention) | B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention) | C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention.
v.Endometriosis Health Profile score
时间窗: The study outcomes will be assessed at the following time points | A) Baseline (before starting the intervention) | B) At 12 weeks, i.e., immediately after the intervention (within 24-48 hours after the delivery of the last session of the 3-month intervention) | C) At 24 weeks, i.e., outcomes will also be assessed after 3 months post-intervention.
次要结局
- Anthropometric measurements- will be collected to assess the physical characteristics of participants, including:(1. height)
研究者
Divya Sharma
Post Graduate Institute of Medical Education and Research (PGIMER)