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RECRUITING

NCT07683715

Virtual Reality-Assisted Cast Application in Children With Forearm Fractures

Sponsor: Başakşehir Çam & Sakura City Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Does Virtual Reality Reduce Pain, Anxiety, Physiologic Stress, and Return-Visit Fear During Pediatric Forearm Casting? A Randomized Controlled Trial

Key Details

Gender

All

Age Range

4 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-05

Completion Date

2026-09-01

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Forearm Fractures Procedural Anxiety Doctor-Related Fear

Interventions

BEHAVIORAL

Virtual Reality-Based Educational Animation

Children assigned to the virtual reality group will watch a 3-minute child-friendly educational animated video through a VR headset during cast application. The video explains the cast application procedure, cast protection, and post-cast care instructions. The intervention is intended to reduce procedural distress through immersive visual and auditory distraction and age-appropriate education.

OTHER

Standard Care

Children assigned to the control group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.

Inclusion Criteria: * Children aged 4 to 15 years. * Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees bayonet apposition ok if \<10 years and growth remains) * First cast application for the current fracture episode. * Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments. * Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance when necessary. * At least one upper extremity free of immobilization, allowing heart rate assessment during the procedure. * Parent or legal guardian able to provide written informed consent. * Child assent when appropriate according to age and local ethics committee requirements. * Ability and willingness of the child and caregiver to attend an approximately 30-minute blinded child psychiatry assessment 1 day after cast application. Exclusion Criteria: * Open forearm fracture. * Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment. * Need for emergency surgery, procedural sedation, or general anesthesia during cast application. * Previous participation in this study. * Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric disorder that may interfere with questionnaire-based evaluation. * Known epilepsy, photosensitive seizure disorder, severe motion sickness, vestibular disorder, or any condition considered unsafe for VR headset use. * Visual or hearing impairment preventing use of the VR intervention or completion of the assessments. * Head, face, or scalp injury preventing safe or comfortable use of a VR headset. * Nausea, dizziness, or severe discomfort before the procedure that would prevent VR use. * Refusal of the child or caregiver to participate. * Inability to complete the 1-day child psychiatry follow-up assessment.

Locations (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Istanbul, Turkey (Türkiye)