Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy
1 other identifier
interventional
17
0 countries
N/A
Brief Summary
Dysregulation of the brain-gut-axis is believed to underlie symptom generation in irritable bowel syndrome (IBS). The Autonomous Nervous System (ANS) is an important route of brain-gut communication and aberrant ANS functioning, reflected in abnormalities in Heart Rate Variability (HRV) have been described in IBS. Gut-directed hypnotherapy (GHT) leads to symptom reductions in IBS and is supposed to increase parasympathetic regulation. To date, however, the role of therapeutic modulation of the ANS through GHT has been rarely examined. Aim of this pilot study is therefore to assess the impact of GHT on ANS functioning as reflected in heart rate variability. 24h-electrocardiogram before and after 10 sessions of gut-directed hypnotherapy will be administered in groups. Time and Frequency measures of Heart Rate Variability (HRV) will be extracted from 24h-electrocardiogram protocols as indicators of ANS regulation. Validated questionnaires will be utilized to assess IBS symptoms (IBS-SSS) and psychological distress (HADS-D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedMarch 17, 2022
March 1, 2022
1.6 years
August 10, 2021
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Heart Rate Variability
Standard Deviation of the NN-Interval (SDNN)
24 hours
Secondary Outcomes (1)
Irritable bowel syndrome symptom severity
10 days
Study Arms (1)
Intervention group
EXPERIMENTAL10 weekly sessions of gut-directed hypnotherapy (behavioral intervention).
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of IBS classified by Rome-IV-criteria
- refractory to diet interventions and symptomatic IBS-medications
- age between 18 and 70 years
You may not qualify if:
- pregnancy
- diabetes mellitus
- untreated thyroid disease
- cardiovascular disorders or arrhythmias
- medications possibly interfering with heart rate variability
- nicotine consumption
- bowel surgery
- mental retardation
- current history of severe psychiatric disorder
- over one hour driving time to the hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of psychosomatic Gastroenterology Outpatient Clinic
Study Record Dates
First Submitted
August 10, 2021
First Posted
March 17, 2022
Study Start
December 7, 2016
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
March 17, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share