Pain Elimination and Anxiety Control Through Experiential Virtual Reality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-21
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Active Virtual Reality
DeviceActive virtual reality group will play a game through a virtual environment.
Passive Virtual Reality
DevicePassive virtual reality group will watch a movie through a virtual environment.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Active Virtual RealityExperimental treatment 1 intervention
Group B: Passive Virtual RealityExperimental treatment 1 intervention
Group C: Standard of CareNo intervention 0 interventions
Trial outcomes
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).
Time frame
5 minutes before, immediately after procedureSecondary outcomes
1
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).
Time frame
5 minutes before, immediately after procedure2
Mean Change from Baseline in Heart Rate after IV Placement
Heart Rate will be measured 5 minutes before, during, and immediately after procedure
Time frame
5 minutes before, during, and immediately after procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: