Schizophenia DisorderNCT06718556
Virtual Reality for Visual Perception on Schizophrenia
A study testing Virtual reality and Client-centered in people with Schizophenia Disorder and Virtual Reality, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophenia Disorder, Virtual Reality, Visual Perception
- What is being tested?
- Virtual reality and Client-centered
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Intervention for Visual Perception in Schizophrenia-A Single Blind Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Schizophenia Disorder, Virtual Reality, Visual Perception
- Being tested
- Virtual reality, Client-centered
- Keywords
- schizophrenia, virtual reality, visual perception, client centered, intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
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
Client-centeredBehavioural
The client-centered (CC) intervention procedure for individuals with schizophrenia was created using literature and the intervention procedure is presented below:
- Active Communication and Evaluation
- Daily Routine, Roles, and Occupational Performance
- Strengths and Barriers
- Intervention Program Development
- Implementation of the intervention program
- Feedback and Revision:
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | 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. Receives: Behavioral: Virtual reality; Behavioral: Client-centered |
| Control group | Experimental | 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. Receives: Behavioral: Client-centered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor-Free Visual Perception Test-3rd Edition-MVPT 3
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkan Torpil, PhD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718556
- Sponsor's protocol ID
- 2022/08-07
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torpil B, Cetinkaya M. Virtual reality intervention for visual perception in schizophrenia-a single blind pilot randomized controlled trial. BMC Psychiatry. 2025 Nov 28;25(1):1204. doi: 10.1186/s12888-025-07664-9.
PubMed 41316190
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Intervention for Visual Perception in Schizophrenia-A Single Blind Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06718556
- Acronym / sponsor ID
- 2022/08-07
- Conditions
- Schizophenia Disorder, Virtual Reality, Visual Perception
- Keywords
- schizophrenia, virtual reality, visual perception, client centered, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Behavioral: Virtual reality, Behavioral: Client-centeredThe 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. |
| Control group | Experimental | Behavioral: Client-centeredClient-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThe 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 | Behavioural | Virtual reality group |
| Client-centeredThe client-centered (CC) intervention procedure for individuals with schizophrenia was created using literature and the intervention procedure is presented below: 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: | Behavioural | Control group, Virtual reality group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 41316190Torpil B, Cetinkaya M. Virtual reality intervention for visual perception in schizophrenia-a single blind pilot randomized controlled trial. BMC Psychiatry. 2025 Nov 28;25(1):1204. doi: 10.1186/s12888-025-07664-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Client-centered in people with Schizophenia Disorder and Virtual Reality, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor-Free Visual Perception Test-3rd Edition-MVPT 3 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.