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

July 1, 2026 updated by: Lezgin Mert, Başakşehir Çam & Sakura City Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Basaksehir Çam Ve Sakura City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
Time Frame: 1 day after cast application
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Anxiety Score During Cast Application
Time Frame: 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
Time Frame: 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
Time Frame: Before, during, and 2 minutes after 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
Time Frame: During cast application
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
Time Frame: During cast application
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
Time Frame: 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
Time Frame: Immediately after cast application
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
Time Frame: Immediately after cast application
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
Time Frame: Before and immediately 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
Time Frame: 1 day after cast application
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
Time Frame: From cast application to 1-day follow-up
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
Time Frame: 1 day after cast application
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
Time Frame: Immediately after cast application
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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