An interventional study of Active Virtual Reality and Passive Virtual Reality in Procedural Pain and Procedural Anxiety, sponsored by Children's Hospital Los Angeles. Not yet recruiting. Open to participants aged 8 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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]:
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 96 is close to the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Children and adolescents 8-21 years old undergoing IV placement .
Exclusion Criteria:
Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).
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
Within the passive virtual reality group virtual environment and age appropriate movie.
Device: Passive Virtual Reality
Participants will receive standard of care distraction methods.
Active virtual reality group will play a game through a virtual environment.
Passive virtual reality group will watch a movie through a virtual environment.
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 procedure
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 procedure
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 procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Mar 2025, 6 months later.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 6 months is below that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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