The Effects of Relaxation Using Virtual Reality in Forensic Psychiatric Patients. A Randomized Cross-over Clinical Trial (VRelax-TAU)

August 5, 2025 updated by: University Hospital, Ghent

During this clinical Cross-over study, the investigators want to investigate whether the use of Virtual Reality (VR) is a valuable application to achieve relaxation in forensic psychiatric patients.

This study investigates the short- and medium-term effect of VRelax on both acute and chronic stress and compares it with a standard relaxation exercise of choice (TAU).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During this clinical Cross-over study, it will be investigated whether the use of Virtual Reality (VR) is a valuable application to achieve relaxation in forensic psychiatric patients within the PC Sint-Jan Baptist, Zelzate, Belgium. Due to the fact that very realistic situations can be created in VR environments that forensic psychiatric patients normally cannot experience due to their limited freedom, it seems to be an extra important asset for them that meets the limitations of confinement and freedom-restricting measures. In addition, the highly immersive character of the application supports patients who are unable to perform a standard relaxation exercise through their own imagination or empathy.

This study investigates the short- and medium-term effect of VRelax on both acute and chronic stress and compares it with a standard relaxation exercise of choice (TAU).

The relaxation software that that will be used in the study is VRelax (www.vrelax.com), which is available in Dutch (and English) for which the results of a first crossover randomized controlled trial was recently published.

The research design is a crossover randomized controlled trial with two parts: a standard relaxation of choice and a VR relaxation using the VRelax software. The VRelax app contains 360˚ VR videos of relaxing natural environments. The variety of landscapes includes beaches, mountains, proximity to animals, etc. Interactive elements are embedded in the videos, for example a game of popping air bubbles underwater, shooting stars in a night sky and audio tracks of relaxation exercises.

The study population consists of forensic psychiatric patients (depressive disorder, bipolar disorder, anxiety disorder or psychotic disorder, borderline, antisocial disorder,… (DSM-5 diagnosis)) who reside in the Sint-Jan Baptist psychiatric hospital in Zelzate, Belgium.

Before the start of the study, each candidate will be invited to an introductory session with VR to see if the person is not participating in VR disease and to make sure that the patient is still willing to participate. After consent, a baseline measurement is performed by the patient during 20 minutes, for the physical parameters using the Embrace plus device (see below).

The study will consist of 2 blocks of 10 sessions: 1 block with and 1 block without VR. Each individual is his own control in this way. Both the control measurement as the VR measurements are done in the VR room, sitting, during 20 min. The control measurement is a relaxation of choice eg. reading a book, listening to music, watching a movie, body scan, play a computer game ... The choice of relaxation form wille be registrated each session. Each block of 10 sessions must be completed within 3 the investigatorseks per patient, follothe investigatorsd by a month of rest and then the 2nd block of relaxation sessions must also be completed within 3 the investigatorseks. Each patient will therefore have 3 to 5 relaxation sessions per the investigatorsek during the study.

The VR measurement will be conducted using VRelax, which has one or more 360° videos of your choice. Only the guided meditation sessions are not used as the eyes have to be closed for that. The choice of videos per session is recorded.

Before and after each session, stress is measured via VAS scores for stress/tension and happiness on paper. At the beginning and end of each block of 10 sessions, the general stress state is measured via the "perceived stress scale" questionnaire on paper and will take 5 minutes to fill in. After the last session of each block, there is also a structured qualitative interview about the user experiences which will take 15 minutes of time.

Some physical parameters are also measured during each relaxation session via an Embrace Plus device (www.Empatica.com). These are heart rate, heart rate variability (HRV), respiratory rate, skin conductance and skin temperature.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Zelzate, Belgium, 9060
        • PC Sint-Jan Baptist

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be admitted for at least 4 months as a forensic psychiatric patient within medium or high security, at Sint-Jan Baptist in Zelzate.

Exclusion Criteria:

  • Acute psychosis, acute mania, epilepsy, pacemaker, balance disorders, individuals in the acute withdrawal phase of substance or alcohol abuse, severe cardiac abnormalities, serious eye disorders, pregnancy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Relaxation sessions groep 1
there will be 10 sessions of VR and 10 sessions of standard relaxation
Device: VR relaxation
Relaxation with a VR glass and 360° video's of nature
Other: Standard relaxation
Relaxation with music, reading a book, playing computer game
Experimental: Relaxation sessions groep 2
there will be 10 sessions of standard relaxation and 10 sessions of VR
Device: VR relaxation
Relaxation with a VR glass and 360° video's of nature
Other: Standard relaxation
Relaxation with music, reading a book, playing computer game

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in VAS Score for relaxation
Time Frame: 20 minutes
on a scale of 1-10 How relaxed are you feeling at this moment?
20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in VAS Score for cheerfullness
Time Frame: 20minutes
on a scale from 1-10 how cheerfull do you feel at this moment?
20minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kurt Audenaert, Prof, University Hospital, Ghent

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONZ-2023-0315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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