Pain Elimination and Anxiety Control Through Experiential Virtual Reality

Not Applicable

Not yet recruiting

• Conditions: Procedural Pain; Procedural Anxiety
• Interventions: Device: Passive Virtual Reality; Device: Active Virtual Reality

• Registration Number: NCT06504602
• Lead Sponsor: Children's Hospital Los Angeles

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-18
• Study Start: 2024-09-01
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Children and adolescents 8-21 years old undergoing IV placement .

  • Ability to understand study procedures and to comply with them for the entire length of the study.
  • Participants and caregiver speaking English or Spanish.

Exclusion Criteria

• Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).

  • Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).
  • Participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation).
  • Critically ill Participants (ESI 1).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive Virtual Reality	Passive Virtual Reality	Within the passive virtual reality group virtual environment and age appropriate movie.
Active Virtual Reality	Active Virtual Reality	Within the active virtual reality group virtual environment, participants will play the game Bearblast using Oculus Go Headset for patients 8-21 years old. In BearBlast, participants travel on a pre-set path through an interactive environment.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement	5 minutes before, immediately after procedure	Pain score on Faces Pain Scale - Revised will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 10. Higher scores correlate to a worse outcome (more pain).

Secondary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement	5 minutes before, immediately after procedure	Anxiety score on Visual Analog Scale will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 100. Higher scores correlate to a worse outcome (more anxiety).
Mean Change from Baseline in Heart Rate after IV Placement	5 minutes before, during, and immediately after procedure	Heart Rate will be measured 5 minutes before, during, and immediately after procedure