Clinical trial NCT06718556: Virtual Reality for Visual Perception on Schizophrenia
Official title: Virtual Reality Intervention for Visual Perception in Schizophrenia-A Single Blind Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophenia Disorder
Virtual Reality
Visual Perception
Keywords: schizophrenia
virtual reality
visual perception
client centered
intervention
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers have stated in the literature that visual perception is negatively affected in schizophrenia. In recent years, virtual reality interventions have become popular in the treatment of schizophrenia. However, there are no virtual reality studies that directly focus on visual perception. This study was planned to examine the effect of virtual reality intervention on visual perception in individuals with schizophrenia.

Detailed description: The current study was planned as a pilot randomized controlled study and the study was conducted using the CONSORT checklist. Participants who met the inclusion and exclusion criteria and signed the written consent form were divided into 2 groups by simple random method. VR and client-centered intervention procedure was applied to the intervention group, and client-centered intervention procedure was applied to the control group. The intervention procedure was planned to consist of 8 weeks, 3 days a week and 45-minute sessions in total.

The study evaluated 64 individuals diagnosed with schizophrenia. 57 individuals with schizophrenia who completed the assessment and met the inclusion/exclusion criteria were included. These 57 individuals were given a number on the computer and then randomization was performed on the computer, and 29 participants were included in the VR group and 28 in the control group. During the intervention process, two individuals in each group who could not participate regularly were excluded from the study and the study was completed with 53 participants. The randomization process was carried out by a researcher who was independent of the study and did not know the assessment and intervention process.

Measurement Sociodemographic information of the participants, such as age, gender, marital status, education and employment status, was collected. After the sociodemographic data were collected, the Motor-Free Visual Perception Test-3rd Edition (MVPT-3) was used to evaluate the visual perceptions of the participants before and after the interventions.

Interventions Virtual reality intervention procedure The VR intervention program was carried out in a 30-meter2 area covered with soft ground to prevent injuries. "The Microsoft Kinect for Xbox 360" was used for the VR intervention. For the current study, a team of experts was formed to select the games to be used within the VR intervention program. This team determined which skills were required for the games to be run successfully, which skills could be developed, which games were purposeful, and independently observed each game. As a result, 9 different games were chosen. The VR intervention procedure was created by utilizing the literature.

Client-centered intervention procedure

The client-centered (CC) intervention procedure for individuals with schizophrenia was created using literature. This intervention procedure consists of 6 steps. These steps are:

1. Active Communication and Evaluation
2. Daily Routine, Roles, and Occupational Performance
3. Strengths and Barriers
4. Intervention Program Development
5. Implementation of the intervention program
6. Feedback and Revision In addition, studies have been conducted on both visual perception and social skills with personalized targeted tasks. In order to develop visual perception, interventions were made to the participants to develop the parameters of visual perception skills such as visual memory, visual closure, shape-ground perception, visual discrimination, visual completion, spatial orientation, etc., which are sub-parameters of visual perception skills. In addition, studies have been conducted to develop social skills, especially basic social skills such as "listening to others, making requests, expressing positive emotions and expressing unpleasant emotions".

Statistically analysis Data were analyzed with SPSS version 29.0 statistical software package program. The normality of the data was analyzed by using Kolmogorov-Smirnov test. Nonparametric tests were used because the data did not show a normal distribution. Differences between groups were analyzed with chi-square test for nominal data. Comparisons between the groups were conducted by using the Mann-Whitney U test. Pre- to post-intervention changes within the groups were analyzed with the Wilcoxon signed-rank test. Significance was evaluated at levels of 0.05. Effect size was calculated by using the means and standard deviations of the groups. Effect size benchmarks were determined as \<0.30, 0.30-0.80, and \>0.80 and considered small, moderate, and strong, respectively.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with schizophrenia by a psychiatrist according to DSM-5 criteria.
* Age between t 18 and 65.
* Ability to understand and follow verbal instructions.
* Active and voluntary participation in the study.
* Being stated to be in clinical remission by a psychiatrist.

Exclusion Criteria:

* Having any chronic disease (neurological, orthopedic, psychiatric, cancer, epilepsy etc.) in addition to schizophrenia that may affect the study.
* Presence of mental retardation.
* Inability to complete the intervention procedure.

Primary outcomes:
measure: Motor-Free Visual Perception Test-3rd Edition-MVPT 3
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
References: