Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in abdominal bloating severity
研究概览
简要总结
The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.
详细描述
This study consists of seven pre-recorded hypnotherapy sessions that will be digitally delivered to patients on their own electronic devices via an existing digital platform provided by metaMe Health. metaMe Health is a company specialized in the delivery of digital hypnotherapy protocols. The sessions will be delivered to patients over twelve weeks in accordance with current gut-direct hypnotherapy practice. The patients must agree to have their consent and content delivered electronically and provide periodic outcomes by completing electronic symptom questionnaires. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in abdominal bloating severity
时间窗: Baseline, 6 weeks, 12 weeks, and 3 months
Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
次要结局
- Change in quality of life(Baseline, 6 weeks, 12 weeks, and 3 months)
- Bloating symptoms(Baseline, 6 weeks, 12 weeks, and 3 months)
- Change in perception of GI symptoms(Baseline, 6 weeks, 12 weeks, and 3 months)
- Health care utilization(Baseline, 12 weeks, and 3 months)
研究者
Xiao Jing (Iris) Wang
Principal Investigator
Mayo Clinic