NCT06504602

Pain Elimination and Anxiety Control Through Experiential Virtual Reality

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\[s\] it aims to answer \[is/are\]: * Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care? * Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care? If there is a comparison group: Researchers will compare active group to passive group and standard of care. Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.

Conditions

• Procedural Pain
• Procedural Anxiety

Interventions

Type	Name	Description
DEVICE	Active Virtual Reality	Active virtual reality group will play a game through a virtual environment.
DEVICE	Passive Virtual Reality	Passive virtual reality group will watch a movie through a virtual environment.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-03-15
• Completion: 2025-03-15
• First posted: 2024-07-17
• Last updated: 2024-07-18

Regulatory

• FDA-regulated device study