Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-26

Study Completion Date

2025-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bloating

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypnotherapy for bloating symptoms

Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically

Group Type EXPERIMENTAL

Hypnotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No