Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

NCT05572606 | Completed

• 1 other identifier: 22-005844
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bloating

Keywords

Hypnotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bloating symptoms

  Baseline, 6 weeks, 12 weeks, and 3 months

• Change in perception of GI symptoms

  Baseline, 6 weeks, 12 weeks, and 3 months

• Change in quality of life

  Baseline, 6 weeks, 12 weeks, and 3 months

• Health care utilization

  Baseline, 12 weeks, and 3 months

Study Arms (1)

Hypnotherapy for bloating symptoms

EXPERIMENTAL

Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically

Behavioral: Hypnotherapy

Interventions

Hypnotherapy BEHAVIORAL

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.

Hypnotherapy for bloating symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Xiao Jing (Iris) Wang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: January 26, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)