Pain Elimination and Anxiety Control Through Experiential Virtual Reality

NCT06504602 | Not Yet Recruiting FDA Device

• 1 other identifier: CHLA-24-00171
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Procedural Pain; Procedural Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement

  5 minutes before, immediately after procedure

• Mean Change from Baseline in Heart Rate after IV Placement

  5 minutes before, during, and immediately after procedure

Study Arms (3)

Active Virtual Reality

EXPERIMENTAL

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

Passive Virtual Reality

EXPERIMENTAL

Within the passive virtual reality group virtual environment and age appropriate movie.

Device: Passive Virtual Reality

Standard of Care

NO INTERVENTION

Participants will receive standard of care distraction methods.

Interventions

Active Virtual Reality DEVICE

Active virtual reality group will play a game through a virtual environment.

Active Virtual Reality

Passive Virtual Reality DEVICE

Passive virtual reality group will watch a movie through a virtual environment.

Passive Virtual Reality

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matan Paret, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matan Paret, MD

CONTACT

3233764793; mparet@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: September 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share