- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06839196
Home Accidents Training For Parents of CWSN
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sıla Yılmaz
- Phone Number: +90 444 85 44
- Email: yilmazsila18@gmail.com
Study Contact Backup
- Name: Ebru Sever
- Email: fztebrusever@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Failure to meet one or more of the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 1 day
|
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.
|
1 day
|
|
Balance
Time Frame: 1 day
|
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.
|
1 day
|
|
Balance
Time Frame: 1 day
|
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.
|
1 day
|
|
Gait
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tülay Ortabağ, Prof., İstanbul Topkapı University
- Study Director: Gönül Ertunç Gülçelik, Asst. Prof., Kocaeli University
- Principal Investigator: Ebru Sever, M.Sc., Kocaeli University
- Principal Investigator: Tuba Eryiğit, M.Sc., İstanbul Topkapı University
- Principal Investigator: Sıla Yılmaz, M.Sc., İstanbul Medipol University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GAP-2024-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Virtual Reality
-
The Cleveland ClinicRecruitingEndoscopy | Virtual Reality | Ergonomics | Virtual Reality HeadsetUnited States
-
Royal National Orthopaedic Hospital NHS TrustNot yet recruitingVirtual Reality | Education, Medical | Virtual Reality Simulation
-
Cairo UniversityCompletedVirtual Reality | Pediatric Burn | Immersive Virtual Reality | Passive Virtual RealityEgypt
-
Stanford UniversityRecruitingVirtual Reality | Augmented RealityUnited States
-
National Taiwan University HospitalRecruiting
-
National Taiwan University HospitalNot yet recruiting
-
Charles River AnalyticsNational Institute of Environmental Health Sciences (NIEHS); The New England...Completed
-
Ardahan UniversityCompleted
-
The Methodist Hospital Research InstituteNational Institute on Aging (NIA)CompletedVirtual RealityUnited States
Clinical Trials on VR and first aid training
-
Centre for Evidence-Based Practice, BelgiumBelgian Red Cross; Rwanda Red CrossCompletedEmergencies | Injuries | Illness PhysicalRwanda
-
Halic UniversityActive, not recruitingFirst Aid | Agricultural Workers' HealthTurkey
-
Nurhayat Kiliç BayageldiCompletedSelf-Efficacy | Nursing Students | Crisis Intervention | Emergency PreparednessTurkey
-
Burdur Mehmet Akif Ersoy UniversityCompletedIntellectual Disability, Mild | First Aid TrainingTurkey
-
Sydney Children's Hospitals NetworkCompleted
-
Selcuk UniversityEnrolling by invitationFirst Aid TrainingTurkey (Türkiye)
-
Institut et Haute Ecole de la Santé la SourceHEIG-VD- Haute Ecole d'Ingénierie et de Gestion du Canton de VaudCompletedPreventative MedicineSwitzerland
-
Harran UniversityNot yet recruitingWorker Disease, AgriculturalTurkey
-
Leanne SaxonInstitute of Public Accountants; Beyond Blue; WorkSafe Victoria; Mental Health...Completed
-
Abant Izzet Baysal UniversityActive, not recruitingTrauma | Psychological Trauma | Disaster; PersonalityTurkey (Türkiye)