Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT03435367
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2018-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department: A Feasibility Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department. Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting. In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion. The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction. If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.
Detailed Description:
This study is a pilot randomized control trial that aims to (a) to determine the differences in self-reported and proxy-reported pain and fear during IV insertion between the interactive VR intervention and control group, and (b) to assess the feasibility (safety, acceptability) of the VR intervention to children/families and the healthcare team in the pediatric emergency department. The study will consist of two study arms, where both study arms will be screened and recruited using the same procedure. Participants will be randomized into either (1) Control group: child life specialist plays an age-appropriate video on a tablet device, or (2) Intervention (VR Distraction): child life specialist facilitates immersive VR experience. Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics). A convenience sample of 80 children and adolescents with cancer (40 participants per treatment arm; 20 boys and 20 girls per treatment arm) will be recruited. In addition to usual care, children in the experimental condition will wear the VR headset plus headphones. In the control condition, children will watch a video (i.e., an age-appropriate video selected by an emergency department affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition. Implementation outcomes include accrual and retention rates, acceptability and technical difficulties. Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: