Perioperative Virtual Reality for Pediatric Anesthesia

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Device: Perioperative virtual reality headset with mobile app

• Registration Number: NCT03583450
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Study Start: 2018-08-29
• Primary Completion: 2019-03-27
• Study Completion: 2019-03-27
• Results First Submitted: 2020-04-06
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Results First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perioperative virtual reality headset	Perioperative virtual reality headset with mobile app	Perioperative virtual reality headset with mobile app and routine anesthetic care

Primary Outcome Measures

Name	Time	Method
Perioperative Pediatric Anxiety (Change From Baseline)	(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

Name	Time	Method
Perioperative Parental Anxiety (Change From Baseline)	(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.
Induction Compliance Checklist	(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)
Parental Satisfaction	(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.

Trial Locations

Locations (1)

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States