Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05283655 |
| Other study ID # |
179079 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 7, 2016 |
| Est. completion date |
June 30, 2018 |
Study information
| Verified date |
March 2022 |
| Source |
Medical University of Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
