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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Irritable Bowel Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 10 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.
Heart Rate Variability
Standard Deviation of the NN-Interval (SDNN)
Measured: 24 hours
Secondary outcomes (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.
- First posted17 Mar 2022
- Study start7 Dec 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Moser, Medical University of Vienna
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy
- ClinicalTrials.gov ID
- NCT05283655
- Acronym / sponsor ID
- 179079
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Gut-directed hypnotherapy10 weekly sessions of gut-directed hypnotherapy (behavioral intervention). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of IBS classified by Rome-IV-criteria
- refractory to diet interventions and symptomatic IBS-medications
- age between 18 and 70 years
Key exclusion criteria (10 listed)
- pregnancy
- diabetes mellitus
- untreated thyroid disease
- cardiovascular disorders or arrhythmias
- medications possibly interfering with heart rate variability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut-directed hypnotherapyhypnotherapy | Behavioural | Intervention group |
Primary outcome
Heart Rate Variability
Time frame: 24 hours
Standard Deviation of the NN-Interval (SDNN)
1 secondary outcome
Irritable bowel syndrome symptom severity
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.