Virtual Reality-Assisted Cast Application in Children With Forearm Fractures
Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorBaşakşehir Çam & Sakura City Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality-Based Educational Animation
BehavioralChildren 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.
Standard Care
Other interventionChildren 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.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality-Assisted Cast ApplicationExperimental treatment 1 intervention
Group B: Standard Cast ApplicationActive comparator 1 intervention
Trial outcomes
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.
Time frame
1 day after cast applicationSecondary outcomes
1
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.
Time frame
During cast application2
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.
Time frame
During cast application3
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.
Time frame
Before, during, and 2 minutes after cast application4
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.
Time frame
During cast applicationSponsors and contacts
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Source ClinicalTrials.gov
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