Perioperative Virtual Reality for Pediatric Anesthesia
1 other identifier
interventional
71
1 country
1
Brief Summary
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Aug 2018
Shorter than P25 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedStudy Start
First participant enrolled
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2019
CompletedResults Posted
Study results publicly available
July 8, 2020
CompletedJuly 8, 2020
June 1, 2020
7 months
June 18, 2018
April 6, 2020
June 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Perioperative Pediatric Anxiety (Change From Baseline)
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
(Day 0 + 15 minutes on average from initial baseline) On entering the OR
Perioperative Pediatric Anxiety (Change From Baseline)
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
(Day 0 + 30 minutes on average from initial baseline) During mask induction
Secondary Outcomes (3)
Perioperative Parental Anxiety (Change From Baseline)
(Day 0 + 45 minutes on average from initial baseline) After mask induction
Induction Compliance Checklist
(Day 0 + 30 minutes on average from initial baseline) During mask induction
Parental Satisfaction
(Day 0 + 45 minutes on average from initial baseline) After mask induction
Other Outcomes (4)
Anesthesia Length
(Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Surgery Length
(Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Pre-medication Given
(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
- +1 more other outcomes
Study Arms (2)
Perioperative virtual reality headset
EXPERIMENTALPerioperative virtual reality headset with mobile app and routine anesthetic care
Control
NO INTERVENTIONRoutine anesthetic care
Interventions
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
Eligibility Criteria
You may qualify if:
- Patients aged 5-12 years
- Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
You may not qualify if:
- Patients with injuries to the head/face that would prohibit wearing of headsets
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Benioff Children's Hospital
San Francisco, California, 94158, United States
Related Publications (1)
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.
PMID: 32618627DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jina Sinskey
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Jung
UCSF Medical Center
- PRINCIPAL INVESTIGATOR
Jina Sinskey, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
July 11, 2018
Study Start
August 29, 2018
Primary Completion
March 27, 2019
Study Completion
March 27, 2019
Last Updated
July 8, 2020
Results First Posted
July 8, 2020
Record last verified: 2020-06