Pain Elimination and Anxiety Control Through Experiential Virtual Reality

Children's Hospital Los Angeles

Status: Not yet enrolling

Conditions: Procedural Anxiety; Procedural Pain

Treatments: Device: Passive Virtual Reality; Device: Active Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06504602

CHLA-24-00171

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 8 to 21 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups

Active Virtual Reality

Experimental group

Description:

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.

Treatment:

Device: Active Virtual Reality

Passive Virtual Reality

Experimental group

Description:

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

Treatment:

Device: Passive Virtual Reality

Standard of Care

No Intervention group

Description:

Participants will receive standard of care distraction methods.