NCT06839196

Brief 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. 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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

January 28, 2025

Last Update Submit

April 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 days

Secondary Outcomes (4)

  • Balance

    1 day

  • Balance

    1 day

  • Balance

    1 day

  • Gait

    1 day

Study Arms (1)

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.

Other: VR and first aid training

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Tülay Ortabağ, Prof.

    İstanbul Topkapı University

    STUDY CHAIR
  • Gönül Ertunç Gülçelik, Asst. Prof.

    Kocaeli University

    STUDY DIRECTOR
  • Ebru Sever, M.Sc.

    Kocaeli University

    PRINCIPAL INVESTIGATOR
  • Tuba Eryiğit, M.Sc.

    İstanbul Topkapı University

    PRINCIPAL INVESTIGATOR
  • Sıla Yılmaz, M.Sc.

    İstanbul Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 21, 2025

Study Start

June 20, 2025

Primary Completion

September 20, 2025

Study Completion

December 20, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04