NCT07676136

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Jul 2028

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

hypnosis

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Recruitment rate is the proportion enrolled among eligible patients approached.

    Up to 1 year.

  • Number of participants who adhered to intervention

    Proportion of participants completing ≥1 hypnosis session during hospitalization and total number of listens

    3 months.

  • Retention rate

    Retention rate is defined as survey completion at baseline, 1 week, 1 month, and 3 months.

    3 months.

Study Arms (2)

Hypnosis

EXPERIMENTAL

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.

Behavioral: Gut directed hypnotherapy via telephone intervention

Education

SHAM COMPARATOR

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.

Behavioral: Educational recording

Interventions

Participants will undergo a self-directed gut-directed hypnosis intervention over the telephone.

Hypnosis

Participants will listen to educational material over the telephone about their gastrointestinal symptoms.

Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeAbdominal PainEsophageal Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Irene Sonu, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor in Medicine

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations