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Completed

NCT Number: NCT03583450

Perioperative Virtual Reality for Pediatric Anesthesia

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Perioperative virtual reality headset with mobile app

Device

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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