Clinical trial NCT03583450: Perioperative Virtual Reality for Pediatric Anesthesia
Official title: Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Virtual Reality
Pediatric Anesthesia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 71
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Perioperative Pediatric Anxiety (Change From Baseline)
timeFrame: (Day 0 + 15 minutes on average from initial baseline) On entering the OR
measure: Perioperative Pediatric Anxiety (Change From Baseline)
timeFrame: (Day 0 + 30 minutes on average from initial baseline) During mask induction
Secondary outcomes:
measure: Perioperative Parental Anxiety (Change From Baseline)
timeFrame: (Day 0 + 45 minutes on average from initial baseline) After mask induction
measure: Induction Compliance Checklist
timeFrame: (Day 0 + 30 minutes on average from initial baseline) During mask induction
measure: Parental Satisfaction
timeFrame: (Day 0 + 45 minutes on average from initial baseline) After mask induction
Other outcomes:
measure: Anesthesia Length
timeFrame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR
measure: Surgery Length
timeFrame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR
measure: Pre-medication Given
timeFrame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
measure: Parent Present for Induction
timeFrame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
Locations:
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
Study officials:
affiliation: UCSF Medical Center
name: Michael Jung
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jina Sinskey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.