Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.
研究概览
简要总结
This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD.
The study hypothesis include:
- the study will achieve greater than 75% program completion and 75% study assessment completion
- patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment
- outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life
- will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult outpatients (18 years and older) that carry a diagnosis of IBD and confirmed in the electronic health record (EHR) as receiving IBD-targeted treatment
- •IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
- •Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
- •Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)
排除标准
- •Patients that do not report pain (i.e., score<2) as they are less likely to benefit from VR-directed BGBT
- •Patients with a history of conditions that could potentially be harmed by VR including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.
研究组 & 干预措施
Enhanced treatment as usual (E-TAU)
干预措施: E-TAU (Other)
VR-directed BGBT
干预措施: VR-directed BGBT (Device)
结局指标
主要结局
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.
时间窗: 4 weeks
The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.
VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale
时间窗: 4 weeks
This is a 10-question scale that participants choose from 1 (disagree strongly) - 7 (agree strongly). Scores range from 10-70 with higher scores indication greater acceptability.
VR-BGBT usability using the System Usability Scale
时间窗: 4 weeks
This is a 10-question scale that participants choose from 1 (strongly agree) - 5 (strongly disagree). Scores range from 0 to 100 with a higher score indicating greater acceptability.
Acceptability of VR-directed BGBT based on a semi-structured post intervention interview
时间窗: 4 weeks
The interview will be done to understand the participants' experience with the VR-directed BGBT intervention and conducted using interview guides with open-ended questions. interview guides will focus on four main domains related to participant's pain history, experience with VR-directed BGBT (including tolerability and acceptability of each BGBT module), perceived impact (including information on any components that were perceived to be most helpful or ineffective), and suggested improvements for program refinement.
次要结局
未报告次要终点
研究者
Shirley Cohen-Mekelburg
Assistant Professor of Internal Medicine
University of Michigan