NCT03568227

Brief 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). For that purpose, 50 healthy participants highly familiar with hypnosis (according to the OMNI-method) will be recruited and tested.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

June 7, 2018

Last Update Submit

November 26, 2018

Conditions

Keywords

HypnosisNeurophysiologyfMRIResting-StateHypnotic Sub-States

Outcome Measures

Primary Outcomes (1)

  • Differences in resting state functional connectivity (assessed using fMRI) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)

    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)

    90 minutes

  • Differences respiratory frequency (assessed during fMRI measurements) between the four conditions (control state 1 & 2, hypnotic state 1 & 2)

    90 minutes

Study Arms (1)

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.

Procedure: HypnosisProcedure: Control

Interventions

HypnosisPROCEDURE

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

Healthy Subjects
ControlPROCEDURE

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.

Healthy Subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65
  • Proficient in German language
  • Written informed consent after being informed
  • Familiar with hypnotic states of OMNI-Hypnosis

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8032, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 25365125BACKGROUND
  • Jensen 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.

    PMID: 29034102BACKGROUND
  • McGeown 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.

    PMID: 25557062BACKGROUND
  • Terhune 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.

    PMID: 28174078BACKGROUND
  • Varga 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.

    PMID: 28836922BACKGROUND

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 26, 2018

Study Start

July 13, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations