N/A
Completed N=23
Functional Dyspepsia Hypnosis
Source: ClinicalTrials.gov NCT03884270 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Percent of Participants That Complete the Hypnotherapy Program — 22 Participants
Summary
The purpose of this study is to evaluate the efficacy of a hypnotherapy treatment program for functional dyspepsia that can be self-administered using on-line audio recordings. This is a non-randomized study. All patients will receive 7 sessions of hypnotherapy treatment administered over a 12-week period.
The primary objective of the study is to determine the feasibility and acceptability of the self-administered hypnotherapy program. The secondary objective is to evaluate the effect of the treatment on participant reported symptom severity, quality of life, anxiety and depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants That Complete the Hypnotherapy Program |
22 | — |
| PRIMARY Treatment Satisfaction |
1; 0; 0; 2; 12; 4 | — |
| PRIMARY Satisfaction With Web Platform |
17; 3; 1; 1; 0; 0 | — |
| SECONDARY The Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Will be Used to Assess Changes in Functional Dyspepsia Symptoms |
-0.82 | — |
| SECONDARY The Short Form Nepean Dyspepsia Index (NDI-SF) Will be Used to Assess Changes in Quality of Life Related to Functional Dyspepsia. |
-9.65 | — |
| SECONDARY The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety. |
10.39 | — |
| SECONDARY The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress. |
-9.22 | — |
| SECONDARY Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. |
2; 1; 2; 1 | — |
| SECONDARY Number of Medications Used for Functional Dyspepsia |
1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of functional dyspepsia by a gastroenterologist
- Meeting ROME IV diagnostic criteria for functional dyspepsia
- At least 18 yrs of age (no upper age limit)
- Able to give informed consent
- English speaking
- Have daily personal access to the Internet via laptop or desktop computer, tablet or a smartphone.
Exclusion Criteria
- Concomitant organic gastrointestinal disease
- Diagnosed or presenting with serious mental illness (e.g., eating disorder, schizophrenia, psychosis, obsessive-compulsive disorder, post-traumatic stress disorder, or a dissociative disorder)
- Cognitive or language barriers that make completion of questionnaires difficult or limit understanding of a verbal intervention (hypnosis)
Data sourced from ClinicalTrials.gov (NCT03884270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.