Virtual Reality-Assisted Cast Application in Children With Forearm Fractures (VR-CAST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Procedural Anxiety; Forearm Fractures; Doctor-Related Fear
• Intervention / Treatment: Behavioral: Virtual Reality-Based Educational Animation; Other: Standard Care

Detailed Description

Forearm fractures are common injuries in children and frequently require cast immobilization. Although cast application is a routine orthopedic procedure, children may experience pain, anxiety, fear, and physiologic stress during the procedure. In some children, this experience may also lead to fear of returning to the hospital or doctor, sometimes referred to as doctor-related or white coat-related fear.

Virtual reality may help children during medical procedures by providing immersive visual and auditory distraction. In addition, an age-appropriate educational video may reduce uncertainty by explaining what will happen during the procedure and how the child should care for the cast afterward.

This study is designed as a prospective, randomized, parallel-group clinical trial. Children with forearm fractures requiring cast application will be randomized into two groups: a virtual reality group and a standard care group. Children in the virtual reality group will wear a Meta Quest 3 headset during cast application and watch a 3-minute child-friendly animated educational video generated using Google Flow. The video explains the cast application process, cast protection, and post-cast care instructions. Children in the standard care group will undergo routine cast application without virtual reality. Apart from the virtual reality intervention, all clinical care will be the same between the two groups.

During cast application, the orthopedic casting team will record procedural pain, procedural anxiety, heart rate before the procedure, mean heart rate during the procedure, heart rate after a 2-minute recovery period, procedure duration, whether the virtual reality headset was removed, and whether nausea, dizziness, or discomfort occurred. Caregivers will also rate the child's anxiety, their own anxiety, and the child's pain before and after the procedure.

One day after cast application, each child will undergo an approximately 30-minute follow-up assessment by a child psychiatry clinician who is blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used. This blinded assessment will evaluate the child's current anxiety, anxiety related to the cast experience, anxiety while returning to the hospital or doctor, reluctance to return to the doctor, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.

The primary objective of the study is to determine whether virtual reality reduces cast-related anxiety and subsequent doctor-related fear after cast application. Secondary objectives include evaluating the effect of virtual reality on procedural pain, procedural anxiety, heart rate response, caregiver anxiety, procedure duration, virtual reality tolerability, and caregiver preference for future use of virtual reality during similar procedures.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lezgin Mert, MD; Phone Number: +905056003904; Email: lezginmert@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34010
      • Recruiting
      • Basaksehir Cam ve Sakura City Hospital
      • Contact: Lezgin Mert; Phone Number: 05346009380; Email: lezginmert@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality-Assisted Cast Application; Children in this group will undergo cast application while watching a 3-minute child-friendly educational animated video through a VR headset. The video explains the cast application procedure, cast protection, and post-cast care instructions. Apart from the VR intervention, routine orthopedic care will be provided.	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.
Active Comparator: Standard Cast Application; Children in this group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day	Cast-related fear and anxiety will be assessed 1 day after cast application by a child psychiatry clinician blinded to group allocation using a structured questionnaire. The assessment will evaluate the child's fear or anxiety related to the cast experience, reluctance to return to the doctor or hospital, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.	1 day after cast application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Anxiety Score During Cast Application	The orthopedic casting team will assess the child's anxiety during cast application using a 0-100 score, where higher scores indicate greater procedural anxiety.	During cast application
Procedural Pain Score During Cast Application	The orthopedic casting team will assess the child's pain during cast application using a 0-10 score, where higher scores indicate greater procedural pain.	During cast application
Change in Heart Rate During Cast Application	Heart rate will be recorded before cast application, during the procedure, and after a 2-minute recovery period. Changes in heart rate from baseline to the procedural and recovery periods will be compared between groups.	Before, during, and 2 minutes after cast application
Procedure Duration	The duration of cast application will be recorded in minutes from the start of the cast application procedure to completion of the procedure. Procedure duration will be compared between the virtual reality group and the standard care group.	During cast application
Physician-Rated Procedural Difficulty Score	The physician performing the cast application will rate the procedural difficulty using a 0-10 score according to the child's cooperation, movement, crying, fear response, and overall behavioral reaction during cast application. Higher scores indicate greater procedural difficulty.	During cast application
Child Behavioral Response During Cast Application	The child's behavioral response during cast application will be assessed by the casting physician. The assessment will include cooperation, crying, avoidance behavior, agitation, movement during the procedure, and overall tolerance of the cast application.	During cast application
Caregiver-Rated Child Anxiety	Caregivers will rate how anxious they think their child is using a 0-100 score, where higher scores indicate greater child anxiety.	Immediately after cast application
Caregiver Anxiety Score	Caregivers will rate their own anxiety using a 0-100 score, where higher scores indicate greater caregiver anxiety.	Immediately after cast application
Caregiver-Rated Child Pain Before and After Cast Application	Caregivers will rate the child's pain before and after cast application using a 0-10 score, where higher scores indicate greater pain.	Before and immediately after cast application
Doctor-Related Fear at Follow-up	Doctor-related fear after the cast experience will be assessed by a blinded child psychiatry clinician using a structured questionnaire. The assessment will include anxiety while returning to the hospital or doctor and reluctance to return to the doctor after the cast experience.	1 day after cast application
Post-Procedural Fear-Related Behaviors at Home	Fear-related behaviors at home after cast application will be assessed by the blinded child psychiatry clinician using caregiver and child responses. These behaviors may include fear, crying, sleep disturbance, reluctance to visit the doctor, or other procedure-related distress.	From cast application to 1-day follow-up
Distress When Remembering the Cast Procedure	The child's distress when remembering the cast application procedure will be assessed by the blinded child psychiatry clinician using a structured questionnaire item. Higher scores or more severe responses indicate greater procedure-related distress.	1 day after cast application
Caregiver Preference for Future Virtual Reality Use	Caregivers will be asked whether they would want virtual reality to be used again if a similar procedure is required. Responses will be recorded as yes, no, or undecided.	Immediately after cast application

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital

Publications and helpful links

General Publications

• Georgiadis AG, Schavee PE, Koester TM, DeBruin WT, Burkitt CC, Truong WH, Laine JC. Virtual Reality as an Adjunct to Pediatric Cast Removal: A Randomized Controlled Trial. JB JS Open Access. 2025 Apr 18;10(2):e24.00244. doi: 10.2106/JBJS.OA.24.00244. eCollection 2025 Apr-Jun.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Pediatric Forearm Fracture; Cast Application; Procedural Distress; Educational Animation
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2024KAEK11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request. Shared data will not include names, national identification numbers, contact information, or any directly identifiable personal information. Because the study includes children and child psychiatry assessments, data sharing will be limited to anonymized research data and will require approval by the principal investigator and compliance with applicable ethics committee and institutional regulations.
• IPD Sharing Time Frame: Data will become available beginning 6 months after publication of the main study results and will be available for 5 years.
• IPD Sharing Access Criteria: Data may be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator. Data will be shared only for approved research purposes and after completion of any required data use agreement and ethics or institutional approvals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No