Hypnosis Induction and Height Experience in VR - Control Group Comparison and Three Sessions

September 25, 2024 updated by: University Hospital Tuebingen

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

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

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Tuebingen, Baden-Württemberg, Germany, 72076
        • Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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).
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height intervention questionnaire (immediately before the intervention)
Time Frame: Immediately (circa 1 minute) before the height exposure in all three sessions
Measurement of acrophobia
Immediately (circa 1 minute) before the height exposure in all three sessions
Height intervention questionnaire (immediately after the intervention)
Time Frame: Immediately (circa 1 minute) after the height exposure in all three sessions
Measurement of acrophobia
Immediately (circa 1 minute) after the height exposure in all three sessions
Height intervention questionnaire (one-week-follow-up)
Time Frame: One week after the third height exposure
Measurement of acrophobia
One week after the third height exposure
Height intervention questionnaire (three-months-follow-up)
Time Frame: Three months after the third height exposure
Measurement of acrophobia
Three months after the third height exposure
Subjective fear rating during height exposure
Time Frame: always 5 seconds after each rise in the height exposure in all three sessions
Measurement of Fear on Likert scale (0 to 9)
always 5 seconds after each rise in the height exposure in all three sessions
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
Measurement of Suggestibility (minimum value = 0, maximum value = 5, higher scores imply higher suggestibility)
at a separate day within the three weeks, where the interventions take place

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Scale for Trance Depth
Time Frame: (circa 5 minutes) after the height exposure in all three sessions
Measurement of Trance Depth (minimum value = 38, maximum value = 152, higher scores imply higher subjective trance depth)
(circa 5 minutes) after the height exposure in all three sessions
Igroup Presence Questionaire
Time Frame: (circa 3 minutes) after the height exposure in all three sessions
Subjective Presence in the VR-experience (minimum value = -42, maximum value = +42, higher scores imply higher subjective presence)
(circa 3 minutes) after the height exposure in all three sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dirk Revenstorf, Prof., University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Actual)

July 22, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 521/2019BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In the case of a publication of the results we will share deidentified individual participant data.

IPD Sharing Time Frame

The data will become available when the results are published.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe