- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06618456
Hypnosis Induction and Height Experience in VR - Control Group Comparison and Three Sessions
Hypnosis Induction and Height Experience in Virtual Reality - Comparison With Control Group and Investigation of the Effect of Three Sessions
This study attempts to test wether a VR-supported trance induction and a subsequent exposure to altitude in VR with hypnotic suggestions via Audio reduces acrophobia more than a control-group intervention without trance induction. Furthermore the study attempts to test if three sessions of the interventions within three weeks can lead to a stronger reduction of acrophobia than only one session.
Participants will be selected via an online survey according to their score on the Height Interpersonal Questionnaire (HIQ). At the start of the study, participants will be screened by professional clinicians for any mental disorders. In the laboratory they will undergo one of the two interventions in VR (experimental group / control group) and complete questionnaires for three times within three weeks. On a separate day within these three weeks they will be placed in a 30-minute trance to test their suggestibility.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prior to the measurement, those interested in the study will complete a screening questionnaire on acrophobia (HIQ) online. Besides they will be asked if they ever had negative experiences with VR or hypnosis. Only persons who do not report negative experiences with VR or hypnosis and who attain a HIQ score bigger than 29 will be invited to take part in the study. At the first appointment in the laboratory a screening with SCID questions about disorders that would lead to exclusion is conducted. On the basis of this second screening participants will be admitted to the study. Failure to meet the criteria (see eligibility section) will exclude participants from the study. At the start of the assessment session, participants will complete a sociodemographic questionnaire and again the HIQ.
Participants are randomly assigned to one of the two groups. Based on group affiliation they either undergo a VR-supported trance induction or the same VR-program without the trance induction. Then there is an automatic transition to the altitude confrontation. Both groups receive the same VR altitude confrontation, the only difference is that in the experimental group a tree is presented near the participant whereas in the control group a parasol is presented at the same position. Thus the sentences that refer to the tree are changed in the audio of the control group. The height is increased to a maximum of 60 metres. Participants can stop the experiment at any time by pressing a button on a handheld joystick. During the confrontation, various events (e.g. rising balloons) generate additional altitude cues. The duration of the confrontation is approximately 15 minutes. Subsequently participants complete questionnaires about their fear of heights (HIQ) for a post-measurement of altitude anxiety and about their experience of presence (IPQ) and their experience of hypnotic depth (SSTT). Participants will undergo these questionnaires and the intervention three times within three weeks. On a separate day within these three weeks they will be placed in a 30-minute trance and given the Harvard Group Scale of Hypnotic Susceptibility (HGSHS) to test their suggestibility.
The total time required for the participants ist therefore approximately three hours and 15 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Baden-Württemberg
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Tuebingen, Baden-Württemberg, Germany, 72076
- Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- HIQ-Score > 29
- informed consent
Exclusion Criteria:
- Negative previous experience with hypnosis
- Negative previous experience with virtual reality
- Mental illness (psychosis, post-traumatic stress disorder and/or personality disorder)
- neurological disease
- Acute or chronic disease (also anamnestic) that may affect brain metabolism:
- pre-existing diabetes mellitus (E10-E14 according to ICD-10)
- Renal insufficiency from stage 3 of the Kidney Disease Outcomes Quality Initiative
- Uncontrolled hypertension (I10.x according to ICD-10)
- Moderate or severe traumatic brain injury (GCS 3-12), or traumatic brain injury 2nd or 3rd degree with loss of consciousness of > 30 minutes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Participants undergo an VR-supported trance induction.
Participants will see an underwater world adapted to the sound (i.e.
text) of the trance.
The following exposure will be nearly the same for both groups (see differences in study design).
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Participants experience a VR dive through a friendly underwater world.
They get a trance induction via audio.
The participants go through a height exposure.
They start at the ground level of a virtual city and move upwards in 3 meter steps until they reach a height of 60 meters.
Participants focus on a yellow spot on a balcony in front of them, so that they can recognise the depth perimeter.
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Active Comparator: Control group
Participants see the same underwater world in VR but receive no trance induction.
The following exposure will be nearly the same for both groups (see differences in study design).
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The participants go through a height exposure.
They start at the ground level of a virtual city and move upwards in 3 meter steps until they reach a height of 60 meters.
Participants focus on a yellow spot on a balcony in front of them, so that they can recognise the depth perimeter.
Participants experience a VR dive through a friendly underwater world.
They are informed that this part of the VR is a familiarization phase to the VR and they do not get a trance induction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Height intervention questionnaire (immediately before the intervention)
Time Frame: Immediately (circa 1 minute) before the height exposure in all three sessions
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Measurement of acrophobia
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Immediately (circa 1 minute) before the height exposure in all three sessions
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Height intervention questionnaire (immediately after the intervention)
Time Frame: Immediately (circa 1 minute) after the height exposure in all three sessions
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Measurement of acrophobia
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Immediately (circa 1 minute) after the height exposure in all three sessions
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Height intervention questionnaire (one-week-follow-up)
Time Frame: One week after the third height exposure
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Measurement of acrophobia
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One week after the third height exposure
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Height intervention questionnaire (three-months-follow-up)
Time Frame: Three months after the third height exposure
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Measurement of acrophobia
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Three months after the third height exposure
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Subjective fear rating during height exposure
Time Frame: always 5 seconds after each rise in the height exposure in all three sessions
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Measurement of Fear on Likert scale (0 to 9)
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always 5 seconds after each rise in the height exposure in all three sessions
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Harvard Group Scale of Hypnotic Susceptibility (german brief form HGHSH-5)
Time Frame: at a separate day within the three weeks, where the interventions take place
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Measurement of Suggestibility (minimum value = 0, maximum value = 5, higher scores imply higher suggestibility)
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at a separate day within the three weeks, where the interventions take place
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective Scale for Trance Depth
Time Frame: (circa 5 minutes) after the height exposure in all three sessions
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Measurement of Trance Depth (minimum value = 38, maximum value = 152, higher scores imply higher subjective trance depth)
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(circa 5 minutes) after the height exposure in all three sessions
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Igroup Presence Questionaire
Time Frame: (circa 3 minutes) after the height exposure in all three sessions
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Subjective Presence in the VR-experience (minimum value = -42, maximum value = +42, higher scores imply higher subjective presence)
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(circa 3 minutes) after the height exposure in all three sessions
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dirk Revenstorf, Prof., University Hospital Tuebingen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 521/2019BO2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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