Procedural Pain, Procedural Anxiety
Conditions
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.
Interventions
DEVICEActive Virtual Reality
Active virtual reality group will play a game through a virtual environment.
DEVICEPassive Virtual Reality
Passive virtual reality group will watch a movie through a virtual environment.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement | 5 minutes before, immediately after procedure | 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). |
| Mean Change from Baseline in Heart Rate after IV Placement | 5 minutes before, during, and immediately after procedure | Heart Rate will be measured 5 minutes before, during, and immediately after procedure |
Contacts
Primary ContactMatan Paret, MD
Outcome results
None listed