A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Measure changes in GERD symptoms using the GERDQ questionnare
研究概览
简要总结
The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).
详细描述
The primary aim of this study is to assess the overall feasibility of virtual reality for the treatment of noncardiac chest pain and identify problems, issues, or challenges that may impact the performance of a future clinical trial. As such, the study will focus on willingness to participate, patient adherence, patient retention, and burdensomeness of the intervention and survey instruments. As a lesser objective, we will assess the effectiveness of virtual reality in patients with noncardiac chest pain at improving pain severity, symptom hypervigilance, anxiety, quality of life, and resilience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain)
- •Negative prior cardiac evaluation (at a minimum, including electrocardiogram)
- •Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality
排除标准
- •Initiation of a proton pump inhibitor (PPI) within 8 weeks
- •Major concomitant illness
- •Current drug or alcohol use that that would interfere with adherence to study requirements
- •Symptoms of vertigo or dizziness that would limit tolerability of the VR headset
研究组 & 干预措施
VR Arm
Viritual Reality therapy arm. All patients will receive virtual reality therapy.
干预措施: Virtual Reality (Other)
结局指标
主要结局
Measure changes in GERD symptoms using the GERDQ questionnare
时间窗: Week 2
Gastroesophageal reflux disease (GERD) questionnaire (GerdQ) is a 6-item questionnaire (scale from 0 to 18) that measures heartburn, regurgitation, abdominal pain, nausea, sleep disorders, and the over-the-counter (OTC) drugs use. The score predicts the likelihood of GERD, with a score between 11-18 suggesting 89% or greater likelihood.
Measure changes in GERD quality of life using the GERD-HRQL questionnaire
时间窗: Week 2
GERD-HRQL- Gastroesophageal reflux disease (GERD) - Health Related Quality of Life (HRQL) The scale has 15 items, which focus on heartburn symptoms, dysphagia, medication effects and health condition. Each item is scored from 0 to 5 (maximum score 75), with a higher score indicating a better QOL
Measure changes in GI symptom severity using the PAGI-SYM questionnaire
时间窗: Week 2
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) The PAGI-SYM includes 6 subscales ranging from 0 (none) to 5 (very severe): heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain.
Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire
时间窗: Week 2
The esophageal hypervigilance and anxiety scale (EHAS) The EHAS is a 15-item measure with two factors evaluating esophageal hypervigilance and symptom specific anxiety scored on a 0-4 Likert scale. Items are summed to yield a total score ranging from 0 - 60 (Greater hypervigilance/anxiety).
Measure changes in GI related patient assessment of quality of life using PAGI-QOL
时间窗: Week 2
Patient Assessment of Gastrointestinal Disorders-Quality of Life (PAGI-QOL) The PAGI-QOL Is an instrument scoring 30 factors each from 0 (none of the time) to 5 (all of the time). Symptoms are assessed over a 2 week period and include the 5 domains daily activities, clothing, diet and food habits, psychological well-being/distress, and relationships.
次要结局
- Measure changes in resilience using the brief resilience scale(Week 2)
- Measure changes in anxiety and depression using the HADs scale(Week 2)
研究者
Andree H. Koop
Principal Investigator
Mayo Clinic