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Irritable Bowel SyndromeNCT05283655

Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy

A study testing Gut-directed hypnotherapy in people with Irritable Bowel Syndrome, run by Medical University of Vienna.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Gut-directed hypnotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
No sites listed yet
Study dates
7 Dec 2016to 30 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of IBS classified by Rome-IV-criteria
  • refractory to diet interventions and symptomatic IBS-medications
  • age between 18 and 70 years

Who cannot join

  • pregnancy
  • diabetes mellitus
  • untreated thyroid disease
  • cardiovascular disorders or arrhythmias
  • medications possibly interfering with heart rate variability
  • nicotine consumption
Show all 10Show fewer
  • bowel surgery
  • mental retardation
  • current history of severe psychiatric disorder
  • over one hour driving time to the hospital

About this study

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).

Read the 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.

Being tested
Gut-directed hypnotherapy
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gut-directed hypnotherapyBehavioural

    hypnotherapy

Study groups in NCT05283655
Study groupRoleWhat they receive
Intervention groupExperimental10 weekly sessions of gut-directed hypnotherapy (behavioral intervention).
Receives: Behavioral: Gut-directed hypnotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate Variability

    Standard Deviation of the NN-Interval (SDNN)

    Measured: 24 hours

Secondary outcomes (1)
  1. 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).

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start7 Dec 2016
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
pre-post intervention
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05283655
Sponsor's protocol ID
179079
Status last verified
Mar 2022
First submitted
10 Aug 2021
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gut-directed hypnotherapy in people with Irritable Bowel Syndrome, run by Medical University of Vienna.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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