Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Change in abdominal bloating severity
Study Overview
Brief Summary
The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in abdominal bloating severity
Time Frame: 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)
Secondary Outcomes
- 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)
Investigators
Xiao Jing (Iris) Wang
Principal Investigator
Mayo Clinic