N/A
N=226
Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
Fractures, Bone · Deformity; Bone
Bottom Line
View on ClinicalTrials.gov: NCT05510232 ↗Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure. — 20; 20; 21 beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A treatment group that will watch a non-VR video via an iPad (Device); A treatment group that will have headset on and will watch a non-VR video (Device); A treatment group that will be immersed in the VR game (Bear Blast) via the headset. (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure. |
20; 20; 21 | — |
| SECONDARY Difference in Visual Analogue Scale (VAS) Pain Score as Measured 3 Minutes Before and Immediately After Intervention |
— | — |
| SECONDARY Difference in Visual Analogue Scale (VAS) Anxiety Score as Measured 3 Minutes Before and Immediately After Intervention |
— | — |
| SECONDARY Parent/Guardian Post-procedure Satisfaction Questionnaire Response |
— | — |
Summary
Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety.
The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.
Eligibility Criteria
Inclusion Criteria
-All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years
Exclusion Criteria
- History of epilepsy and seizures
- Anxiety disorders documented
- Unable to understand/follow VR directions
- History of vertigo and/or dizziness
- History of chronic pain
- Non-English speakers
Data sourced from ClinicalTrials.gov (NCT05510232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.