Study Results
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View full resultsBasic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2018-08-29
2019-03-27
Brief Summary
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Detailed Description
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Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Perioperative virtual reality headset
Perioperative virtual reality headset with mobile app and routine anesthetic care
Perioperative virtual reality headset with mobile app
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
Control
Routine anesthetic care
No interventions assigned to this group
Interventions
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Perioperative virtual reality headset with mobile app
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
Eligibility Criteria
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Inclusion Criteria
* Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
Exclusion Criteria
* Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
* Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
* Patients with a history of or current symptoms of vertigo
* Patients who are blind
* Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
* Patients on whom the VR headset does not fit appropriately
* Non-English speaking patients (due to limited availability of non-English study documents and consents)
5 Years
12 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Michael Jung
Role: PRINCIPAL_INVESTIGATOR
UCSF Medical Center
Jina Sinskey, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Benioff Children's Hospital
San Francisco, California, United States
Countries
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References
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Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-25277
Identifier Type: -
Identifier Source: org_study_id
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