Virtual RealityNCT06996678
Effect of Virtual Reality on Cognitive Skills
A study testing virtual Reality and occupational therapy in people with Virtual Reality, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of virtual reality (VR) intervention on cognitive skills in children with attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Virtual Reality
- What is being tested?
- virtual Reality and occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Sep 2025
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between the ages of 7-12, having diagnosed with ADHD by a child psychiatrist in accordance with the DSM-5 diagnostic criteria, having stabilized medications used for ADHD, being open to communication, and being able to understand and follow instructions at a basic level
Who cannot join
- having any neurological, orthopedic or psychiatric diagnosis in addition to ADHD diagnosis, having undergone any surgical intervention in the last 3 months, being inadequate in understanding visual and auditory commands, and having a visual or hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Virtual Reality on Cognitive Skills in Children With Attention Deficit Hyperactivity Disorders
The aim of this study is to investigate the effects of virtual reality (VR) intervention on cognitive skills in children with attention deficit hyperactivity disorder (ADHD).
Read the detailed description
The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The intervention group will receive occupational therapy (OT) for 30 minutes once a week for 8 weeks and will play a virtual reality (VR) game with the Sony PlayStation 2 Eye Toy system for 20 minutes. Both the intervention and control groups will receive occupational therapy for only 30 minutes once a week for 8 weeks. The Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) will be administered before and after the intervention to assess children's cognitive functions.
- Conditions
- Virtual Reality
- Being tested
- virtual Reality, occupational therapy
- Keywords
- Attention deficit and hyperactivity disorder, cognitive functions, motor skills, Virtual Reality
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual RealityBehavioural
Virtual Reality: The virtual reality system consists of a camera, television, Eye Toy Play CD and Play Station 2. It is based on the principle of capturing movements represented in a virtual environment (Gatica and Méndez, 2014). In the Eye Toy system, individuals can see themselves on the screen through the camera. In this way, the person constantly interacts with the movements and challenges brought by video games. We can simply call the Eye Toy system a webcam with a motion sensor and microphone. The individual's position in the game is determined on the screen and can perceive the person according to the movements he/she exhibits. The main skills required by the games are; target-based movement, visuomotor skills, praxis and thinking process skills.
occupational therapyBehavioural
Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills
| Study group | Role | What they receive |
|---|---|---|
| Aspirin (intervention group) | Active comparator | The intervention group will receive both occupational therapy and virtual reality.a) Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills.
Virtual Reality: The virtual reality system consists of a camera, television, Eye Toy Play CD and Play Station 2. It is based on the principle of capturing movements represented in a virtual environment (Gatica and Méndez, 2014). In the Eye Toy system, individuals can see themselves on the screen through the camera. In this way, the person constantly interacts with the movements and challenges brought by video games. We can simply call the Eye Toy system a webcam with a motion sensor and microphone. The individual's position in the game is determined on the screen and can perceive the person according to the movements he/she exhibits. Receives: Behavioral: virtual Reality; Behavioral: occupational therapy |
| Plasebo (control group) | Active comparator | The control group will receive occupational therapy. Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills. Receives: Behavioral: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch)
The Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch): It was developed to evaluate the cognitive functions of children between the ages of 6 and 12. It includes 22 subtests in 5 cognitive areas; orientation, spatial perception, praxis, visuomotor construction and thinking operations. There is a structured 5-stage scoring system for each subtest. The purpose of the assessment is to identify the child's strengths and deficiencies in different cognitive areas, to measure learning potential and to identify the child's thinking strategies using dynamic procedures. The practice time is approximately 1½ hours
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jul 2025
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with an intervention group and a control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya Ozturk, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996678
- Sponsor's protocol ID
- HÜ-OT-LKO-04
- Status last verified
- Sep 2025
- First submitted
- 21 May 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Virtual Reality on Cognitive Skills in Children With Attention Deficit Hyperactivity Disorders
- ClinicalTrials.gov ID
- NCT06996678
- Acronym / sponsor ID
- HÜ-OT-LKO-04
- Conditions
- Virtual Reality
- Keywords
- Attention deficit and hyperactivity disorder, cognitive functions, motor skills, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 30 May 2025 (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.
The aim of this study is to investigate the effects of virtual reality (VR) intervention on cognitive skills in children with attention deficit hyperactivity disorder (ADHD).
Detailed description
The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The intervention group will receive occupational therapy (OT) for 30 minutes once a week for 8 weeks and will play a virtual reality (VR) game with the Sony PlayStation 2 Eye Toy system for 20 minutes. Both the intervention and control groups will receive occupational therapy for only 30 minutes once a week for 8 weeks. The Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) will be administered before and after the intervention to assess children's cognitive functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with an intervention group and a control group
| Arm | Type | Receives |
|---|---|---|
| Aspirin (intervention group) | Active comparator | Behavioral: virtual Reality, Behavioral: occupational therapyThe intervention group will receive both occupational therapy and virtual reality.a) Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills. Virtual Reality: The virtual reality system consists of a camera, television, Eye Toy Play CD and Play Station 2. It is based on the principle of capturing movements represented in a virtual environment (Gatica and Méndez, 2014). In the Eye Toy system, individuals can see themselves on the screen through the camera. In this way, the person constantly interacts with the movements and challenges brought by video games. We can simply call the Eye Toy system a webcam with a motion sensor and microphone. The individual's position in the game is determined on the screen and can perceive the person according to the movements he/she exhibits. |
| Plasebo (control group) | Active comparator | Behavioral: occupational therapyThe control group will receive occupational therapy. Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- being between the ages of 7-12, having diagnosed with ADHD by a child psychiatrist in accordance with the DSM-5 diagnostic criteria, having stabilized medications used for ADHD, being open to communication, and being able to understand and follow instructions at a basic level
Key exclusion criteria (1 listed)
- having any neurological, orthopedic or psychiatric diagnosis in addition to ADHD diagnosis, having undergone any surgical intervention in the last 3 months, being inadequate in understanding visual and auditory commands, and having a visual or hearing impairment.
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 RealityVirtual Reality: The virtual reality system consists of a camera, television, Eye Toy Play CD and Play Station 2. It is based on the principle of capturing movements represented in a virtual environment (Gatica and Méndez, 2014). In the Eye Toy system, individuals can see themselves on the screen through the camera. In this way, the person constantly interacts with the movements and challenges brought by video games. We can simply call the Eye Toy system a webcam with a motion sensor and microphone. The individual's position in the game is determined on the screen and can perceive the person according to the movements he/she exhibits. The main skills required by the games are; target-based movement, visuomotor skills, praxis and thinking process skills. | Behavioural | Aspirin (intervention group) |
| occupational therapyOccupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills | Behavioural | Aspirin (intervention group), Plasebo (control group) |
Primary outcome
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch)
Time frame: 1 month
The Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch): It was developed to evaluate the cognitive functions of children between the ages of 6 and 12. It includes 22 subtests in 5 cognitive areas; orientation, spatial perception, praxis, visuomotor construction and thinking operations. There is a structured 5-stage scoring system for each subtest. The purpose of the assessment is to identify the child's strengths and deficiencies in different cognitive areas, to measure learning potential and to identify the child's thinking strategies using dynamic procedures. The practice time is approximately 1½ hours
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 29 Sep 2025.
- 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 occupational therapy in people with Virtual Reality, run by Hacettepe University 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 1 inclusion and 1 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 29 Sep 2025. 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?
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.