Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gut-directed hypnotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- diagnosis of IBS classified by Rome-IV-criteria
- refractory to diet interventions and symptomatic IBS-medications
- age between 18 and 70 years
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
10 weekly sessions of gut-directed hypnotherapy (behavioral intervention).
Outcomes
Primary Outcome Measures
Heart Rate Variability
Standard Deviation of the NN-Interval (SDNN)
Secondary Outcome Measures
Irritable bowel syndrome symptom severity
Irritable bowel syndrome - severity scoring system (IBS-SSS), a questionnaire for clinical assessment of IBS symptom burden and severity. Values range between 0 and 500, with higher values representing higher symptom burden. Values can be classified as mild (values ranging between 75-175), moderate (175-300), and severe (300-500).
Full Information
NCT ID
NCT05283655
First Posted
August 10, 2021
Last Updated
March 16, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05283655
Brief Title
Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy
Official Title
Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Background. The autonomous nervous system (ANS) is a key substrate for the regulation of gastrointestinal homeostasis and plays a substantial role in the pathophysiology of IBS. A convincing amount of evidence indicates a relationship between specific patterns of disturbed sympathovagal balance, symptom severity, and IBS subtypes. According to the literature, hypnosis affects sympathovagal balance by inducing elevated parasympathetic nervous system activity and reduced sympathetic tone. Previous studies reported clinical improvements of IBS-symptoms after successful Gut-directed group Hypnotherapy (GHT) over long-term periods but rarely depicted the underlying alterations in ANS regulation.
Aims of the study. The aim of this study is to investigate short- and long-term effects of Gut- directed group Hypnotherapy (GHT) on ANS regulation in refractory IBS-subjects, measured by heart rate variability. We further attempt to reveal differences in effects of GHT treatment on ANS regulation between IBS-subtypes (constipation-predominant vs. diarrheapredominant) and examine the relationship between self-rated hypnotic depth and parasympathetic activity. Methods. Within a period of 29 months, a sample of N=50 consecutive IBS-patients receive GHT treatment (7-10 weekly sessions) at the Psychosomatic Out-patient Clinic, Division of Gastroenterology and Hepatology, University Hospital of Vienna. Alterations in heart rate variability (HRV) are extracted by Electrocardiogram (ECG) recording in supine (30 min), sitting (10 min) and standing (10 min) position. HRV indices of sympathetic and parasympathetic control are quantified by using measures from time and frequency domains. Assessment of psychological variables is carried out by standardized questionnaires: anxiety, depression, stress, resilience, quality of life and IBS symptom burden.
Methods. Recordings of heart rate and R-R intervals will be conducted continuously for 24 hours. Electrocardiogram (ECG) recordings will be performed within one week before the first and after the last session of hypnosis. Patients will previously informed about the practical requirements for the recordings as well as the role of heart rate variability for health and the presumed associations between Autonomous Nervous System function, psychological stress reactivity patterns and digestive function. Recording devices will be mounted and activated at the hospital. Patients will return to their home or work environment and will be instructed not to ingest stimulating drinks (such as coffee, energy drinks), alcohol and not to engage in physical exercises during the whole recording time. Patients will return to the hospital >24h later for removal and readout of the recording devices. Recorded data will be transferred to Kubios HRV® analysis software (version 2.2, Kuopio, Finland) for subsequent analysis. Calculated parameters comprise mean heart rate, square root of the mean squared differences of successive RR intervals (RMSSD), standard deviation of the normal-to-normal interval (SDNN) in the time domain, and and the number of pairs of succession normal-to-normal intervals that differ by more than 50ms divided by the total number of normal-to-normal intervals (pNN50); in the frequency domain low frequency (0.04-0.15 Hz, LF) and high frequency (0.16-0.40 Hz, HF) will be considered as proposed by international guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pre-post intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
10 weekly sessions of gut-directed hypnotherapy (behavioral intervention).
Intervention Type
Behavioral
Intervention Name(s)
Gut-directed hypnotherapy
Intervention Description
hypnotherapy
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
Standard Deviation of the NN-Interval (SDNN)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Irritable bowel syndrome symptom severity
Description
Irritable bowel syndrome - severity scoring system (IBS-SSS), a questionnaire for clinical assessment of IBS symptom burden and severity. Values range between 0 and 500, with higher values representing higher symptom burden. Values can be classified as mild (values ranging between 75-175), moderate (175-300), and severe (300-500).
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of IBS classified by Rome-IV-criteria
refractory to diet interventions and symptomatic IBS-medications
age between 18 and 70 years
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy
We'll reach out to this number within 24 hrs