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OpenTrials
Completed

NCT Number: NCT05572606

Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Bloating symptoms

    Time frame: Baseline, 6 weeks, 12 weeks, and 3 months

    Assessed using the well validated upper GI symptom Severity Index (PAGI-SYM)

  2. Change in perception of GI symptoms

    Time frame: Baseline, 6 weeks, 12 weeks, and 3 months

    Measured using the self-reported Visceral Sensitivity Index (VSI)

  3. Change in quality of life

    Time frame: 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

  4. Health care utilization

    Time frame: Baseline, 12 weeks, and 3 months

    Assessing the number of outpatient visits, portal messages, and procedures generated in three months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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