Accident at HomeNCT06839196
Home Accidents Training For Parents of CWSN
A study testing VR and first aid training in people with Accident at Home and Virtual Reality, run by Medipol University.
Trial summary
The main objective of this project is to raise awareness and equip parents of children with special needs with the knowledge and skills necessary to prevent home accidents through virtual reality applications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accident at Home, Virtual Reality
- What is being tested?
- VR and first aid training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being able to understand and speak Turkish
- Being a parent of a child with special needs
- Having a child registered at a Barrier-Free Life Application and Research Center
- Scoring in the A+ category on the System Usability Scale, with a percentile rank between 96 and 100
- Volunteering to participate in the study
Who cannot join
- Failure to meet one or more of the inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ebru Sever contact
About this study
Official title: Virtual Reality Simulation and First Aid Training for Parents of Children With Special Needs on Home Accidents
The main objective of this project is to raise awareness and equip parents of children with special needs with the knowledge and skills necessary to prevent home accidents through virtual reality applications. Additionally, the project aims to provide parents with basic first aid training and transfer training to ensure appropriate responses in the event of an accident. It also seeks to assess the balance status of children with special needs and to identify potential fall-related risks that may lead to home accidents.
The primary research questions this project aims to address are as follows:
- What is the level of awareness among parents of children with special needs regarding home accidents?
- What is the effect of virtual reality simulation on parental awareness of home accident risks?
- How does first aid training influence parents' ability to respond to home accidents?
- What is the impact of transfer training on parents' preparedness for home accident scenarios?
- What are the balance and gait levels of children with special needs, and how might these relate to fall risk at home?
Read the detailed description
As part of the eligibility process, participants will complete the System Usability Scale, a Likert-type questionnaire, once at the beginning of the study. Only individuals scoring in the A+ category (96th-100th percentile) will be included in the intervention phase.
- Conditions
- Accident at Home, Virtual Reality
- Being tested
- VR and first aid training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR and first aid trainingOther
Intervention Stages:
Stage 1: Descriptive Information Form and the Home Accident Awareness Questionnaire for Parents of Children with Special Needs will be administered to the parents as pre-tests.
Stage 2: A total of 100 parents will participate in the virtual reality simulation scenarios, organized into four separate groups of 25 for implementation.
Stage 3: Balance assessments for children will be conducted using the Children's Balance Assessment Form, the Tinetti Balance and Gait Assessment, and the Nintendo Wii Fit Balance Board.
Stage 4: Each group of 25 participants will receive hands-on training at three different stations focusing on basic first aid and home accidents, delivered by nurses, and transfer training provided by physiotherapists.
Stage 5: Post-tests will be administered to the parents using the Home Accident Awareness Questionnaire for Parents of Children with Special Needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | As part of the eligibility process, participants will complete the System Usability Scale, a Likert-type questionnaire, once at the beginning of the study. Only individuals scoring in the A+ category (96th-100th percentile) will be included in the intervention phase. Receives: Other: VR and first aid training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of home accidents
The Home Accident Awareness Questionnaire for Parents of Children with Special Needs, a 28-item form developed by the researchers, will be administered twice: once before and once after the VR training program.
Measured: 2 days
Secondary outcomes (4)
Balance
The Children's Balance Assessment Form is a yes/no assessment tool developed by the researchers to evaluate the balance status of children with special needs. It will be administered once during Stage 3 of the study.
Measured: 1 day
Balance
The Tinetti Balance and Gait Assessment will be used to evaluate balance abilities. This tool assigns scores to specific tasks, with a maximum of 16 points for the balance subscale. A higher score indicates better balance and lower risk of falling. It will be administered once during Stage 3 of the study.
Measured: 1 day
Balance
The Nintendo Wii Fit Balance Board will be used to evaluate balance abilities through interactive tasks. It will be administered once during Stage 3 of the study.
Measured: 1 day
Gait
The Tinetti Balance and Gait Assessment will also be used to assess gait abilities. The gait subscale has a maximum score of 28. A higher score reflects better gait performance and mobility. This assessment will be performed once during Stage 3 of the study.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start20 Jun 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
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 Accident at HomeStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- İstanbul Topkapı University, Kocaeli University
- Responsible party
- Principal investigator, Sıla YILMAZ, Medipol University
- Investigators
- Tülay Ortabağ, Prof., Study chair, İstanbul Topkapı UniversityGönül Ertunç Gülçelik, Asst. Prof., Study director, Kocaeli UniversityEbru Sever, M.Sc., Principal investigator, Kocaeli UniversityTuba Eryiğit, M.Sc., Principal investigator, İstanbul Topkapı UniversitySıla Yılmaz, M.Sc., Principal investigator, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839196
- Sponsor's protocol ID
- GAP-2024-001
- Status last verified
- Apr 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ertunc Gulcelik G, Ortabag T, Yilmaz S, Sever E, Eryigit T. Virtual reality-based home accident control simulation combined with first aid training to enhance awareness in parents of children with special needs: protocol for a single-group pre-post quasi-experimental study. BMJ Open. 2025 Oct 20;15(10):e105338. doi: 10.1136/bmjopen-2025-105338.
PubMed 41120168
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Simulation and First Aid Training for Parents of Children With Special Needs on Home Accidents
- ClinicalTrials.gov ID
- NCT06839196
- Acronym / sponsor ID
- GAP-2024-001
- Conditions
- Accident at Home, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- İstanbul Topkapı University, Kocaeli University
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 21 Feb 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 main objective of this project is to raise awareness and equip parents of children with special needs with the knowledge and skills necessary to prevent home accidents through virtual reality applications. Additionally, the project aims to provide parents with basic first aid training and transfer training to ensure appropriate responses in the event of an accident. It also seeks to assess the balance status of children with special needs and to identify potential fall-related risks that may lead to home accidents.
The primary research questions this project aims to address are as follows:
- What is the level of awareness among parents of children with special needs regarding home accidents?
- What is the effect of virtual reality simulation on parental awareness of home accident risks?
- How does first aid training influence parents' ability to respond to home accidents?
- What is the impact of transfer training on parents' preparedness for home accident scenarios?
- What are the balance and gait levels of children with special needs, and how might these relate to fall risk at home?
Detailed description
As part of the eligibility process, participants will complete the System Usability Scale, a Likert-type questionnaire, once at the beginning of the study. Only individuals scoring in the A+ category (96th-100th percentile) will be included in the intervention phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VR and first aid trainingAs part of the eligibility process, participants will complete the System Usability Scale, a Likert-type questionnaire, once at the beginning of the study. Only individuals scoring in the A+ category (96th-100th percentile) will be included in the intervention phase. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being able to understand and speak Turkish
- Being a parent of a child with special needs
- Having a child registered at a Barrier-Free Life Application and Research Center
- Scoring in the A+ category on the System Usability Scale, with a percentile rank between 96 and 100
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- Failure to meet one or more of the inclusion criteria
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 |
|---|---|---|
| VR and first aid trainingIntervention Stages: Stage 1: Descriptive Information Form and the Home Accident Awareness Questionnaire for Parents of Children with Special Needs will be administered to the parents as pre-tests. Stage 2: A total of 100 parents will participate in the virtual reality simulation scenarios, organized into four separate groups of 25 for implementation. Stage 3: Balance assessments for children will be conducted using the Children's Balance Assessment Form, the Tinetti Balance and Gait Assessment, and the Nintendo Wii Fit Balance Board. Stage 4: Each group of 25 participants will receive hands-on training at three different stations focusing on basic first aid and home accidents, delivered by nurses, and transfer training provided by physiotherapists. Stage 5: Post-tests will be administered to the parents using the Home Accident Awareness Questionnaire for Parents of Children with Special Needs. | Other | Intervention |
Primary outcome
Awareness of home accidents
Time frame: 2 days
The Home Accident Awareness Questionnaire for Parents of Children with Special Needs, a 28-item form developed by the researchers, will be administered twice: once before and once after the VR training program.
4 secondary outcomes
Balance
Time frame: 1 day
Balance
Time frame: 1 day
Balance
Time frame: 1 day
Gait
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41120168Ertunc Gulcelik G, Ortabag T, Yilmaz S, Sever E, Eryigit T. Virtual reality-based home accident control simulation combined with first aid training to enhance awareness in parents of children with special needs: protocol for a single-group pre-post quasi-experimental study. BMJ Open. 2025 Oct 20;15(10):e105338. doi: 10.1136/bmjopen-2025-105338.
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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.
Ebru Sever contact
Tülay Ortabağ, Prof. study chair
İstanbul Topkapı University
Gönül Ertunç Gülçelik, Asst. Prof. study director
Kocaeli University
Ebru Sever, M.Sc. principal investigator
Kocaeli University
Questions about this trial
What is this clinical trial studying?
A study testing VR and first aid training in people with Accident at Home and Virtual Reality, run by Medipol University.
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 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sıla Yılmaz (+90 444 85 44, yilmazsila18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of home accidents (time frame: 2 days). 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 NCT06839196, 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 4 May 2025.