HypnosisNCT03568227
Hemodynamic Correlates of Distinct Hypnotic States
A study testing Hypnosis in people with Hypnosis, run by Mike Bruegger at 1 site in Switzerland.
Trial summary
The investigation will assess the brain activation connectivity patterns associated with hypnosis and possible hypnotic sub-states by means of functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypnosis
- What is being tested?
- Hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jul 2018to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65
- Proficient in German language
- Written informed consent after being informed
- Familiar with hypnotic states of OMNI-Hypnosis
Who cannot join
- Pre-existing neurological and/or psychiatric conditions
- History of brain injuries
- Alcohol and/or drug abuse
- Chronic diseases that require a permanent intake of drugs
- Additional exclusion criteria for the MRI- and 1H-MRS-experiment:
- General contraindications for a participation on a MRI-Experiment (e.g. claustrophobia, pace maker, cochlea implants, insulin pumps)
Show all 10Show fewer
- Hypersensitivity to loud noise
- Not being able to lie still during a longer period of time
- Foreign metallic objects in the body (e.g. gunshot wounds, metallic particles, metal implants, irremovable piercings)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Investigation of Distinct Hypnotic States - A Resting-State fMRI Study
The investigation will assess the brain activation connectivity patterns associated with hypnosis and possible hypnotic sub-states by means of functional magnetic resonance imaging (fMRI). For that purpose, 50 healthy participants highly familiar with hypnosis (according to the OMNI-method) will be recruited and tested.
Read the detailed description
Despite the growing number of studies investigating of the physiological underpinnings of hypnosis by means of neuroimaging methods such as electroencephalography (EEG) positron emission tomography (PET) and functional magnetic resonance imaging (fMRI), still no consensus exists regarding the underlying neurophysiological working mechanisms due to high levels of variability in the data.
Generally, the variability observed in research examining the neurobiological fundamentals of hypnosis could be attributed to the following characteristics:
- Heterogeneity regarding hypnotic induction procedures.
- Insufficient statistical power.
- Mono-Modality: Studies investigating the neurophysiologic mechanisms of hypnosis typically apply only one method for the investigation of their research questions. However, different techniques complement each other, hence, resulting in a more thorough understanding of the mechanisms of action.
In this project, the investigators present a multimodal approach, in which these three points are considered in order to provide a comprehensive picture with respect to psycho- and neurophysiologic fundamentals of hypnosis and proposed distinct hypnotic states.
Point 1) will be approached by applying a highly reproducible method for the hypnotic induction (OMNI-hypnosis). This hypnosis method is fast, direct and all OMNI educated hypnotherapists follow exactly the same induction procedure. This implies a high level of standardization and operationalization, crucial prerequisites to investigate the phenomenon based on scientific guidelines.
Point 2) will be addressed by including a homogeneous study sample of 50 highly suggestible participants. Furthermore, the comparably high number of 50 participants should ensure sufficient statistical power particularly in consideration of the homogeneity of the study sample.
Point 3) is addressed by following a multimodal approach combining a vast array of psychophysiological measures with multimodal neuroimaging. For that purpose, the project will be divided into three studies: A EEG- and psychophysiological study, a fMRI-study and a magnetic resonance spectroscopy (1H-MRS) study.
In the present study, fMRI is applied for the investigation of network dynamics associated with hypnotic states. Hypnotic states will be compared to control states which follow mock instructions matched to the hypnosis instructions.
- Conditions
- Hypnosis
- Being tested
- Hypnosis, Control
- Keywords
- Hypnosis, Neurophysiology, fMRI, Resting-State, Hypnotic Sub-States
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisProcedure or surgery
The hypnosis intervention consists of two elements: A hypnotic induction and a hypnotic deepening. The induction aims at guiding the participant into the first hypnotic state (state 1). The participants will remain in this state for 10 minutes, the duration of the fMRI-scan. The hypnotic deepening guides the participants into a very deep hypnotic state (state 2). Participants also remain in this state for 10 minutes, during which their brain activity is measured using fMRI
ControlProcedure or surgery
The control intervention consists of texts corresponding to the induction and deepening of the hypnosis intervention. They are matched in duration and consist of textually matched excerpts from www.wikipedia.org. Control induction will be presented, resulting in the control state 1 (10 min). Then the control deepening will be performed, leading to the control state 2 (10 minutes). During both control states the brain activity will be recorded using fMRI.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | The study has a 2 (Intervention: Hypnosis, Control) x 2 (State: 1 \& 2) factorial within-subjects design, resulting in a total of 4 conditions. All volunteers participate at the 4 conditions in the same session.The order of the interventions is counterbalanced resulting in two possible sequences:
Sequence 1: Hypnosis State 1, Hypnosis State 2, Control State 1, Control State 2
Sequence 2: Control State 1, Control State2, Hypnosis State 1, Hypnosis State 2
Volunteers will be randomly allocated to the two sequence types. Receives: Procedure: Hypnosis; Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Measured: 90 minutes
Secondary outcomes (2)
Differences in heart rate variability (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Measured: 90 minutes
Differences respiratory frequency (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start13 Jul 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypnosisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike Bruegger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mike Bruegger, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568227
- Sponsor's protocol ID
- HypnoScienceMRI
- Status last verified
- Nov 2018
- First submitted
- 7 Jun 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing research and practice: the revised APA Division 30 definition of hypnosis. Int J Clin Exp Hypn. 2015;63(1):1-9. doi: 10.1080/00207144.2014.961870.
PubMed 25365125Jensen MP, Jamieson GA, Lutz A, Mazzoni G, McGeown WJ, Santarcangelo EL, Demertzi A, De Pascalis V, Banyai EI, Rominger C, Vuilleumier P, Faymonville ME, Terhune DB. New directions in hypnosis research: strategies for advancing the cognitive and clinical neuroscience of hypnosis. Neurosci Conscious. 2017;3(1):nix004. doi: 10.1093/nc/nix004. Epub 2017 Apr 12.
PubMed 29034102McGeown WJ, Mazzoni G, Vannucci M, Venneri A. Structural and functional correlates of hypnotic depth and suggestibility. Psychiatry Res. 2015 Feb 28;231(2):151-9. doi: 10.1016/j.pscychresns.2014.11.015. Epub 2014 Dec 6.
PubMed 25557062Terhune DB, Cleeremans A, Raz A, Lynn SJ. Hypnosis and top-down regulation of consciousness. Neurosci Biobehav Rev. 2017 Oct;81(Pt A):59-74. doi: 10.1016/j.neubiorev.2017.02.002. Epub 2017 Feb 4.
PubMed 28174078Varga K, Kekecs Z, Myhre PS, Jozsa E. A Neutral Control Condition for Hypnosis Experiments: "Wiki" Text. Int J Clin Exp Hypn. 2017 Oct-Dec;65(4):429-451. doi: 10.1080/00207144.2017.1348833.
PubMed 28836922
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Investigation of Distinct Hypnotic States - A Resting-State fMRI Study
- ClinicalTrials.gov ID
- NCT03568227
- Acronym / sponsor ID
- HypnoScienceMRI
- Conditions
- Hypnosis
- Keywords
- Hypnosis, Neurophysiology, fMRI, Resting-State, Hypnotic Sub-States
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mike BrueggerUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 26 Jun 2018 (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.
The investigation will assess the brain activation connectivity patterns associated with hypnosis and possible hypnotic sub-states by means of functional magnetic resonance imaging (fMRI). For that purpose, 50 healthy participants highly familiar with hypnosis (according to the OMNI-method) will be recruited and tested.
Detailed description
Despite the growing number of studies investigating of the physiological underpinnings of hypnosis by means of neuroimaging methods such as electroencephalography (EEG) positron emission tomography (PET) and functional magnetic resonance imaging (fMRI), still no consensus exists regarding the underlying neurophysiological working mechanisms due to high levels of variability in the data.
Generally, the variability observed in research examining the neurobiological fundamentals of hypnosis could be attributed to the following characteristics:
- Heterogeneity regarding hypnotic induction procedures.
- Insufficient statistical power.
- Mono-Modality: Studies investigating the neurophysiologic mechanisms of hypnosis typically apply only one method for the investigation of their research questions. However, different techniques complement each other, hence, resulting in a more thorough understanding of the mechanisms of action.
In this project, the investigators present a multimodal approach, in which these three points are considered in order to provide a comprehensive picture with respect to psycho- and neurophysiologic fundamentals of hypnosis and proposed distinct hypnotic states.
Point 1) will be approached by applying a highly reproducible method for the hypnotic induction (OMNI-hypnosis). This hypnosis method is fast, direct and all OMNI educated hypnotherapists follow exactly the same induction procedure. This implies a high level of standardization and operationalization, crucial prerequisites to investigate the phenomenon based on scientific guidelines.
Point 2) will be addressed by including a homogeneous study sample of 50 highly suggestible participants. Furthermore, the comparably high number of 50 participants should ensure sufficient statistical power particularly in consideration of the homogeneity of the study sample.
Point 3) is addressed by following a multimodal approach combining a vast array of psychophysiological measures with multimodal neuroimaging. For that purpose, the project will be divided into three studies: A EEG- and psychophysiological study, a fMRI-study and a magnetic resonance spectroscopy (1H-MRS) study.
In the present study, fMRI is applied for the investigation of network dynamics associated with hypnotic states. Hypnotic states will be compared to control states which follow mock instructions matched to the hypnosis instructions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Procedure: Hypnosis, Procedure: ControlThe study has a 2 (Intervention: Hypnosis, Control) x 2 (State: 1 \& 2) factorial within-subjects design, resulting in a total of 4 conditions. All volunteers participate at the 4 conditions in the same session.The order of the interventions is counterbalanced resulting in two possible sequences: Sequence 1: Hypnosis State 1, Hypnosis State 2, Control State 1, Control State 2 Sequence 2: Control State 1, Control State2, Hypnosis State 1, Hypnosis State 2 Volunteers will be randomly allocated to the two sequence types. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65
- Proficient in German language
- Written informed consent after being informed
- Familiar with hypnotic states of OMNI-Hypnosis
Key exclusion criteria (10 listed)
- Pre-existing neurological and/or psychiatric conditions
- History of brain injuries
- Alcohol and/or drug abuse
- Chronic diseases that require a permanent intake of drugs
- General contraindications for a participation on a MRI-Experiment (e.g. claustrophobia, pace maker, cochlea implants, insulin pumps)
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 |
|---|---|---|
| HypnosisThe hypnosis intervention consists of two elements: A hypnotic induction and a hypnotic deepening. The induction aims at guiding the participant into the first hypnotic state (state 1). The participants will remain in this state for 10 minutes, the duration of the fMRI-scan. The hypnotic deepening guides the participants into a very deep hypnotic state (state 2). Participants also remain in this state for 10 minutes, during which their brain activity is measured using fMRI | Procedure or surgery | Healthy Subjects |
| ControlThe control intervention consists of texts corresponding to the induction and deepening of the hypnosis intervention. They are matched in duration and consist of textually matched excerpts from www.wikipedia.org. Control induction will be presented, resulting in the control state 1 (10 min). Then the control deepening will be performed, leading to the control state 2 (10 minutes). During both control states the brain activity will be recorded using fMRI. | Procedure or surgery | Healthy Subjects |
Primary outcome
Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Time frame: 90 minutes
2 secondary outcomes
Differences in heart rate variability (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Time frame: 90 minutes
Differences respiratory frequency (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)
Time frame: 90 minutes
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 27 Nov 2018.
- Background: PubMed 25365125Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing research and practice: the revised APA Division 30 definition of hypnosis. Int J Clin Exp Hypn. 2015;63(1):1-9. doi: 10.1080/00207144.2014.961870.
- Background: PubMed 29034102Jensen MP, Jamieson GA, Lutz A, Mazzoni G, McGeown WJ, Santarcangelo EL, Demertzi A, De Pascalis V, Banyai EI, Rominger C, Vuilleumier P, Faymonville ME, Terhune DB. New directions in hypnosis research: strategies for advancing the cognitive and clinical neuroscience of hypnosis. Neurosci Conscious. 2017;3(1):nix004. doi: 10.1093/nc/nix004. Epub 2017 Apr 12.
- Background: PubMed 25557062McGeown WJ, Mazzoni G, Vannucci M, Venneri A. Structural and functional correlates of hypnotic depth and suggestibility. Psychiatry Res. 2015 Feb 28;231(2):151-9. doi: 10.1016/j.pscychresns.2014.11.015. Epub 2014 Dec 6.
- Background: PubMed 28174078Terhune DB, Cleeremans A, Raz A, Lynn SJ. Hypnosis and top-down regulation of consciousness. Neurosci Biobehav Rev. 2017 Oct;81(Pt A):59-74. doi: 10.1016/j.neubiorev.2017.02.002. Epub 2017 Feb 4.
- Background: PubMed 28836922Varga K, Kekecs Z, Myhre PS, Jozsa E. A Neutral Control Condition for Hypnosis Experiments: "Wiki" Text. Int J Clin Exp Hypn. 2017 Oct-Dec;65(4):429-451. doi: 10.1080/00207144.2017.1348833.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Hypnosis, run by Mike Bruegger at 1 site in Switzerland.
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 4 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2) (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568227, which also lists 5 linked publications.
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 27 Nov 2018.