- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676136
A Pilot Study Using Gut-Directed Hypnotherapy for Hospitalized Patients
June 23, 2026 updated by: Irene Sonu, Stanford University
The purpose of the study is to compare the effectiveness of recorded gut-directed hypnosis to an educational recording in people with chronic problems in their gastrointestinal (GI) system.
Patients who are hospitalized at Stanford Hospital for worsening pain and/or nausea will be considered for enrollment.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults admitted to the GI inpatient service with expected length of stay >24 hours
- Prior diagnosis of a disorder of gut-brain interaction, esophageal disorder, or inflammatory bowel disease
- Reason for hospitalization related to symptom management for exacerbation of visceral pain and/or nausea.
Exclusion Criteria:
- Currently using hypnosis
- severe developmental delay or cognitive impairment
- serious mental illness (i.e. psychosis or dissociation)
- hearing impairment
- Non-English speaking
- enrolled in another trial for GI symptom management
- admitted for GI procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypnosis
Participants will undergo gut-directed hypnotherapy via a phone intervention (10 minute recording, at least once daily while hospitalized) and for as much as participant would like for the 3 month duration of the study.
|
Participants will undergo a self-directed gut-directed hypnosis intervention over the telephone.
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|
Sham Comparator: Education
Participants will listen to educational recording (10 minute recording, at least once daily while hospitalized) and for as much as participant would like for the 3 month duration of the study.
|
Participants will listen to educational material over the telephone about their gastrointestinal symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment rate
Time Frame: Up to 1 year.
|
Recruitment rate is the proportion enrolled among eligible patients approached.
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Up to 1 year.
|
|
Number of participants who adhered to intervention
Time Frame: 3 months.
|
Proportion of participants completing ≥1 hypnosis session during hospitalization and total number of listens
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3 months.
|
|
Retention rate
Time Frame: 3 months.
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Retention rate is defined as survey completion at baseline, 1 week, 1 month, and 3 months.
|
3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Irene Sonu, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
June 23, 2026
First Submitted That Met QC Criteria
June 23, 2026
First Posted (Actual)
June 30, 2026
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Gastroenteritis
- Colonic Diseases, Functional
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Irritable Bowel Syndrome
- Abdominal Pain
- Inflammatory Bowel Diseases
- Esophageal Diseases
Other Study ID Numbers
- 83851
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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