NCT05836597招募中不适用
Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in abdominal pain scores
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria
- •Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.
- •Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation/evaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic.
排除标准
- •Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.
- •Patients with gastroparesis or cyclic vomiting syndrome.
- •Patients with prior surgery to the esophagus, stomach or duodenum.
- •Patients taking opioids.
- •Patients with motion sickness, vertigo, or a seizure disorder
- •IBS symptoms are not predominant.
结局指标
主要结局
Change in abdominal pain scores
时间窗: Baseline, 8 weeks
Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for abdominal pain. Scored 0-5, with higher scores representing more severe symptoms.
次要结局
- Change in nausea/vomiting(Baseline, 8 weeks)
- Change in bloating(Baseline, 8 weeks)
- Change in post-prandial fullness(Baseline, 8 weeks)
- Overall PAGI-SYM scores(Baseline, 8 weeks)
- Change in heartburn(Baseline, 8 weeks)
研究者
David J. Cangemi
Principal Investigator
Mayo Clinic
研究点 (2)
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