Pain Elimination and Anxiety Control Through Experiential Virtual Reality

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Device: Active Virtual Reality; Device: Passive Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matan Paret, MD; Phone Number: 3233764793; Email: mparet@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Active Virtual Reality; Active virtual reality group will play a game through a virtual environment.
Experimental: Passive Virtual Reality; Within the passive virtual reality group virtual environment and age appropriate movie.	Device: Passive Virtual Reality; Passive virtual reality group will watch a movie through a virtual environment.
No Intervention: Standard of Care; Participants will receive standard of care distraction methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement	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).	5 minutes before, immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Heart Rate after IV Placement	Heart Rate will be measured 5 minutes before, during, and immediately after procedure	5 minutes before, during, and immediately after procedure
Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement	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).	5 minutes before, immediately after procedure

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Matan Paret, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Pain, Procedural
• Other Study ID Numbers: CHLA-24-00171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes