Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).
1 other identifier
observational
250
1 country
1
Brief Summary
Adult IBS patients with symptoms refractory to standard medical treatment received nurse-administered, gut-directed hypnotherapy. The primary outcome measure was change in gastro-intestinal symptom severity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2005
Longer than P75 for all trials
1 active site
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 Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFirst Posted
Study publicly available on registry
December 12, 2023
CompletedDecember 12, 2023
December 1, 2023
17.8 years
December 1, 2023
December 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in gastrointestinal symptom severity
Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS). The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100. A total score of all five questions is calculated ranging from 0 to 500. The higher the score the more severe the GI symptoms.
Baseline (week 0), during treatment (week 6), at treatment completion (week 8), follow-up (6 months, 1 and 2 years after treatment initiation)
Study Arms (1)
Nurse-delivered, gut-directed hypnotherapy
Adult patients suffering from irritable bowel syndrome (IBS), with symptoms refractory to standard treatment. Patients referred to a tertiary care center were included.
Interventions
Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8-12 sessions), were given either in an individual manner or in a group setting.The hypnosis treatment is administered by two nurses specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment was based on the North Carolina protocol. Patients assessed gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.
Eligibility Criteria
Adult IBS patients with symptoms refractory to standard treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Magnus Simrén
Gothenburg, Sweden
Related Publications (1)
Lovdahl J, Blomqvist-Storm M, Palsson OS, Ringstrom G, Tornblom H, Simren M, Trindade IA. Nurse-Administered Gut-Directed Hypnotherapy for Irritable Bowel Syndrome: A Two-Year Follow-Up Study. United European Gastroenterol J. 2025 Sep;13(7):1307-1317. doi: 10.1002/ueg2.70060. Epub 2025 Jun 9.
PMID: 40491242DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Simrén, Prof
Göteborg University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffessor, MD
Study Record Dates
First Submitted
December 1, 2023
First Posted
December 12, 2023
Study Start
September 1, 2005
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share