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
- 1
- 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
- •Patients who meet Rome IV criteria for functional abdominal bloating/distension.
- •Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.
- •Patients will be proficient in English language for comprehension of content.
- •Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.
排除标准
- •Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g., scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
- •Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
- •Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded.
- •Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded.
- •Patients with substance abuse disorders and drug addiction will be excluded.
- •Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator.
研究组 & 干预措施
Hypnotherapy for bloating symptoms
Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically
干预措施: Hypnotherapy (Behavioral)
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
- Health care utilization(Baseline, 12 weeks, and 3 months)
- 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)
研究者
Xiao Jing (Iris) Wang
Principal Investigator
Mayo Clinic