Feasibility of a Mindfulness Intervention for Endometriosis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Use of opioid medication
研究概览
简要总结
Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •age 18 years or older
- •diagnosis or probable diagnosis of endometriosis
- •candidate for surgical procedure for endometriosis
- •English speaking
- •have access to wifi and email
排除标准
- •prior formal mindfulness training
- •Unable to consent
结局指标
主要结局
Use of opioid medication
时间窗: 3 months
Morphine milligram equivalent following surgery
Pain intensity
时间窗: 3 months
Numerical Pain Rating Scale 0-10, 10 being highest
次要结局
- Sleep quality (sleep duration, awakenings, efficiency)(1 week following surgery)
- Emotional functioning(3 months)
- Patient global impression of change(1 week)
- Pain catastrophizing(3 months)
- Treatment satisfaction(3 months)
- Sleep quality (sleep duration, awakenings, efficiency)(1 week following surgery)
- Sleep report(1 week prior to surgery)
- Emotional functioning(3 months)
- Patient global impression of change(1 week)
- Pain catastrophizing(3 months)
- Treatment satisfaction(3 months)
- Heart rate variability(baseline)
研究者
Christa Coleman
Assistant Professor, Psychiatry and Behavioral Health
Milton S. Hershey Medical Center