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

NCT07119736 | Completed DMC

• 1 other identifier: ONZ-2023-0315
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Relaxation

Keywords

stress; relaxation; virtual reality

Outcome Measures

Primary Outcomes (1)

• Difference in VAS Score for relaxation

  on a scale of 1-10 How relaxed are you feeling at this moment?

  20 minutes

Secondary Outcomes (1)

• Difference in VAS Score for cheerfullness

  20minutes

Study Arms (2)

Relaxation sessions groep 1

EXPERIMENTAL

there will be 10 sessions of VR and 10 sessions of standard relaxation

Device: VR relaxation; Other: Standard relaxation

Relaxation sessions groep 2

EXPERIMENTAL

there will be 10 sessions of standard relaxation and 10 sessions of VR

Device: VR relaxation; Other: Standard relaxation

Interventions

VR relaxation DEVICE

Relaxation with a VR glass and 360° video's of nature

Relaxation sessions groep 1; Relaxation sessions groep 2

Standard relaxation OTHER

Relaxation with music, reading a book, playing computer game

Relaxation sessions groep 1; Relaxation sessions groep 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

PC Sint-Jan Baptist

Zelzate, 9060, Belgium

Location

Study Officials

• Kurt Audenaert, Prof

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: participant data will be pseudonymized
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups, 2 periods, 2 relaxation types, forensic psychiatric patients

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 13, 2025
• Study Start: January 1, 2024
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)