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Virtual Reality-Assisted Cast Application in Children With Forearm Fractures

Study acronym: VR-CAST
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Başakşehir Çam & Sakura City Hospital to Başakşehir Çam & Sakura City Hospital Show 8 more changesShow less
    • Start date: Dec 5, 2025 to Jul 1, 2026
    • Trial completed
    • Final enrollment: 158 participants (planned 120)
    • Primary completion date changed from estimate of Aug 30, 2026 to Oct 3, 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 11 of 13 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. In the virtual reality group, children will watch a 3-minute child-friendly animated educational video using a VR headset during cast application. The video explains the casting procedure, how to protect the cast, and what the child should do after the cast is applied. The study will compare pain, anxiety, heart rate response, caregiver anxiety, and procedure-related fear between the two groups. The casting team will assess the child during the procedure. One day after cast application, each child will undergo an approximately 30-minute evaluation by a child psychiatry clinician who is blinded to group allocation. This follow-up assessment will evaluate the child's current anxiety, anxiety related to the cast experience, fear of returning to the hospital or doctor, and fear-related behaviors after the procedure.
Trial Details
NCT Number NCT07683715
Lead Sponsor Başakşehir Çam & Sakura City Hospital
Conditions
(from sponsor)		 Forearm Fractures, Procedural Anxiety, Doctor-Related Fear
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov