Virtual Reality-Assisted Cast Application in Children With Forearm Fractures

NCT07683715 | Recruiting

• 1 other identifier: 2024KAEK11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Forearm Fractures; Procedural Anxiety; Doctor-Related Fear

Keywords

Virtual Reality; Pediatric Forearm Fracture; Cast Application; Procedural Distress; Educational Animation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Procedural Anxiety Score During Cast Application

  During cast application

• Procedural Pain Score During Cast Application

  During cast application

• Change in Heart Rate During Cast Application

  Before, during, and 2 minutes after cast application

• Procedure Duration

  During cast application

• Physician-Rated Procedural Difficulty Score

  During cast application

Study Arms (2)

Virtual Reality-Assisted Cast Application

EXPERIMENTAL

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

Standard Cast Application

ACTIVE COMPARATOR

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

Interventions

Virtual Reality-Based Educational Animation BEHAVIORAL

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.

Virtual Reality-Assisted Cast Application

Standard Care OTHER

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.

Standard Cast Application

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 40255492 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Lezgin Mert, MD

CONTACT

+905056003904; lezginmert@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Children, caregivers, and the orthopedic casting team cannot be blinded because the VR headset is visible during cast application. However, the child psychiatry clinician who performs the approximately 30-minute follow-up assessment 1 day after cast application will be blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used during the procedure.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into two parallel groups: a virtual reality-assisted cast application group and a standard cast application group. Children in the virtual reality group will watch a 3-minute educational animated video using a VR headset during cast application, while children in the control group will receive standard cast application without virtual reality. Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available beginning 6 months after publication of the main study results and will be available for 5 years.
• 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.

Locations

TU (1)