Pain Elimination and Anxiety Control Through Experiential Virtual Reality
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Procedural Pain
- Sponsor
- Children's Hospital Los Angeles
- Enrollment
- 96
- Primary Endpoint
- Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Matan Paret
Principal Investigator
Children's Hospital Los Angeles
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).
Outcomes
Primary Outcomes
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
Time Frame: 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 Outcomes
- 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)