- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718556
Virtual Reality for Visual Perception on Schizophrenia
Virtual Reality Intervention for Visual Perception in Schizophrenia-A Single Blind Pilot Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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:
- Active Communication and Evaluation
- Daily Routine, Roles, and Occupational Performance
- Strengths and Barriers
- Intervention Program Development
- Implementation of the intervention program
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- University of Health Sciences Turkey
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality group
The intervention procedure was planned to consist of 8 weeks, 3 days a week and 45-minute sessions in total. In this intervention group, a virtual reality intervention was applied in addition to the client-centered intervention applied to both groups. |
The virtual reality 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 virtual reality intervention.
For the current study, a team of experts was formed to select the games to be used within the virtual reality 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.
Since all games involve similarly intense visual, cognitive and motor skill requirements, game selection was left to the participants' preference during the intervention process to encourage motivation and participation.
The virtual reality intervention procedure was created by utilizing the literature
The client-centered (CC) intervention procedure for individuals with schizophrenia was created using literature and the intervention procedure is presented below:
|
|
Experimental: Control group
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 client-centered (CC) intervention procedure for individuals with schizophrenia was created using literature and the intervention procedure is presented below:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor-Free Visual Perception Test-3rd Edition-MVPT 3
Time Frame: 30 minutes
|
MVPT-3 is a widely used scale for the assessment of visual perception.
The test consists of nine main subheadings, namely visual discrimination (1-8), shape formation (9-13), visual memory-I (14-21), visual closure-I (22-34), visual discrimination (35-45), spatial orientation (46-50), figure-ground (51-55), visual closure-II (56-60) and visual memory-II (61-65), and consists of 65 items.
This test is administered individually to participants between the ages of four and ninety-five.
The first 40 items are administered to children between the ages of four and ten, and the remaining 51 items from item 14 to item 65 are for individuals aged ten and over.
In the study conducted by Metin and Aral for Turkish validity, the Cronbach's alpha coefficient of the test was determined as 0.85.
|
30 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/08-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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