Pain Elimination and Anxiety Control Through Experiential Virtual Reality

NCT ID: NCT06504602

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Virtual Reality

Intervention Type: DEVICE

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

Passive Virtual Reality

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

Group Type: EXPERIMENTAL

Passive Virtual Reality

Intervention Type: DEVICE

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

Standard of Care

Participants will receive standard of care distraction methods.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active Virtual Reality

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

Intervention Type: DEVICE

Passive Virtual Reality

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Matan Paret

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matan Paret, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Central Contacts

Matan Paret, MD

Role: CONTACT

mparet@chla.usc.edu

3233764793

Other Identifiers

CHLA-24-00171

Identifier Type: -

Identifier Source: org_study_id