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Perioperative Virtual Reality for Pediatric Anesthesia

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ClinicalTrials.gov Identifier: NCT03583450
Recruitment Status : Completed
First Posted : July 11, 2018
Results First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Device: Perioperative virtual reality headset with mobile app Not Applicable

Detailed Description:

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. We will be enrolling patients age 5-12 years presenting for elective surgery.

Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Perioperative virtual reality headset
Perioperative virtual reality headset with mobile app and routine anesthetic care
 Device: Perioperative virtual reality headset with mobile app
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
No Intervention: Control
Routine anesthetic care


Outcome Measures
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Primary Outcome Measures :
  1. Perioperative Pediatric Anxiety (Change From Baseline) [ Time Frame: (Day 0 + 15 minutes on average from initial baseline) On entering the OR ]
    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)

  2. Perioperative Pediatric Anxiety (Change From Baseline) [ Time Frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction ]
    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)


Secondary Outcome Measures :
  1. Perioperative Parental Anxiety (Change From Baseline) [ Time Frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction ]
    State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety.

  2. Induction Compliance Checklist [ Time Frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction ]
    Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance)

  3. Parental Satisfaction [ Time Frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction ]
    21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.


Other Outcome Measures:
  1. Anesthesia Length [ Time Frame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR ]
    Length of time that patient received anesthesia care.

  2. Surgery Length [ Time Frame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR ]
    Length of surgery from procedure start to procedure finish

  3. Pre-medication Given [ Time Frame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia ]
    Whether patient was given anxiolytic medication prior to induction of general anesthesia

  4. Parent Present for Induction [ Time Frame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia ]
    Whether parent was present in operating room during induction of anesthesia


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 5-12 years
  • Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583450


Locations
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United States, California
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Michael Jung UCSF Medical Center
Principal Investigator: Jina Sinskey, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol and Statistical Analysis Plan  [PDF] August 22, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03583450    
Other Study ID Numbers: 18-25277
First Posted: July 11, 2018    Key Record Dates
Results First Posted: July 8, 2020
Last Update Posted: July 8, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
Virtual Reality
Pediatric Anesthesia