Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating

The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.

Study Overview

• Status: Completed
• Conditions: Bloating
• Intervention / Treatment: Behavioral: Hypnotherapy

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotherapy for bloating symptoms; Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically	Behavioral: Hypnotherapy; Seven pre-recorded hypnotherapy sessions delivered over the course of twelve weeks via the patient's own electronic device such as a smartphone, tablet, or laptop. The length of the audio-recorded treatment sessions is expected to be approximately 40 minutes on average.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in abdominal bloating severity	Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)	Baseline, 6 weeks, 12 weeks, and 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Xiao Jing (Iris) Wang, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Hypnotherapy
• Additional Relevant MeSH Terms: Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis
• Other Study ID Numbers: 22-005844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No