Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Not Applicable

Active, not recruiting

• Conditions: Bloating
• Interventions: Behavioral: Hypnotherapy

• Registration Number: NCT05572606
• Lead Sponsor: Mayo Clinic

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Study Start: 2022-11-30
• Primary Completion: 2023-12-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypnotherapy for bloating symptoms	Hypnotherapy	Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically

Primary Outcome Measures

Name	Time	Method
Change in abdominal bloating severity	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 Outcome Measures

Name	Time	Method
Change in quality of life	Baseline, 6 weeks, 12 weeks, and 3 months	Assessed via the self-reported EuroQol-5D-5L (EQ-5D-5L) to evaluate mobility, self-care, usual activity, pain/discomfort, and anxiety/depression
Bloating symptoms	Baseline, 6 weeks, 12 weeks, and 3 months	Assessed using the well validated upper GI symptom Severity Index (PAGI-SYM)
Change in perception of GI symptoms	Baseline, 6 weeks, 12 weeks, and 3 months	Measured using the self-reported Visceral Sensitivity Index (VSI)
Health care utilization	Baseline, 12 weeks, and 3 months	Assessing the number of outpatient visits, portal messages, and procedures generated in three months

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States