Perioperative Virtual Reality for Pediatric Anesthesia

Anxiety Clinical Trial

Official title:

Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583450
• Other study ID #: 18-25277
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: March 27, 2019

Study information

• Verified date: June 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety

Intervention

Device:
• Perioperative virtual reality headset with mobile app
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anesthesia Length	Length of time that patient received anesthesia care.	(Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Other	Surgery Length	Length of surgery from procedure start to procedure finish	(Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Other	Pre-medication Given	Whether patient was given anxiolytic medication prior to induction of general anesthesia	(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
Other	Parent Present for Induction	Whether parent was present in operating room during induction of anesthesia	(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
Primary	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
Primary	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	Perioperative Parental Anxiety (Change From Baseline)	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.	(Day 0 + 45 minutes on average from initial baseline) After mask induction
Secondary	Induction Compliance Checklist	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)	(Day 0 + 30 minutes on average from initial baseline) During mask induction
Secondary	Parental Satisfaction	21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.	(Day 0 + 45 minutes on average from initial baseline) After mask induction