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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Virtual Reality | Experimental | 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. |
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| Passive Virtual Reality | Experimental | Within the passive virtual reality group virtual environment and age appropriate movie. |
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| Standard of Care | No Intervention | Participants will receive standard of care distraction methods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Virtual Reality | Device | Active virtual reality group will play a game through a virtual environment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 minutes before, immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 minutes before, immediately after procedure |
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Inclusion Criteria:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matan Paret, MD | Contact | 3233764793 | mparet@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matan Paret, MD | Children's Hospital Los Angeles | Principal Investigator |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Passive Virtual Reality | Device | Passive virtual reality group will watch a movie through a virtual environment. |
|
| Mean Change from Baseline in Heart Rate after IV Placement | Heart Rate will be measured 5 minutes before, during, and immediately after procedure | 5 minutes before, during, and immediately after procedure |