NCT06188793招募中不适用
Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program
研究概览
简要总结
The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting.
The study hypothesizes that:
- At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program
- Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Inflammatory Bowel Disease and self-reported pain
- •Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)
排除标准
- •Patients that do not report pain
- •Anticipated length of hospital stay is less than 72 hours
- •Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
- •Patients with binocular vision loss
- •Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease.
- •Patients that are currently pregnant
研究组 & 干预措施
Virtual reality-directed BGBT
Experimental
干预措施: Virtual reality-directed BGBT (Device)
结局指标
主要结局
Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program
时间窗: 3 days of treatment
次要结局
- Acceptability using the System Usability Scale - patients(Day 3 (post intervention))
- Acceptability using the Treatment Acceptance and Adherence Scale- patients(Day 3 (post intervention))
- Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview(1 week (semi-structured interview within 1 week of completion of the intervention))
研究者
Shirley Cohen-Mekelburg
Assistant Professor
University of Michigan
研究点 (1)
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