Comparison of Virtual Reality to Tablet-based Distraction in Children

March 11, 2021 updated by: Elizabeth Ghazal, Loma Linda University

A Comparison of Virtual Reality Headset and Touch Screen Tablet for Minimizing Anxiety During Separation From Caregiver and Induction of Anesthesia in Children

The proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets. The primary outcome measure being patient anxiety at the time of separation. Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After receiving IRB approval from our institution and consent from parents or guardians, ASA I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were recruited for this study. They were assigned to either tablet- or VR-based groups. At our institution, tablet-based distraction is widely used and represents standard practice. Children in this control group were given tablets in the preoperative holding area before transport to the operating room. Content consisted of entertainment apps providing access to music videos, movies and games targeting various age groups.

The study group was given a Virtual Reality Smartphone headset in the preoperative holding area prior to transport to the operating room. This headset was chosen because of its low cost and wide compatibility for a variety of smartphones. The content consisted of several VR environments that the child/parent could choose from.

In both groups, the distraction with tablet or VR was continued throughout separation from caregivers, transport to the operating room, placement of monitors and mask induction of general anesthesia. Anxiety at time of separation was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was determined by using the Mask Acceptance Scale.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 4-10 years of age
  • Undergoing procedure that requires general anesthesia

Exclusion Criteria:

  • Emergent procedure
  • ASA III-IV
  • Patients with facial skin lesions
  • Patients with significant history of motion sickness
  • Visually impaired patients
  • Patients unable to wear a virtual reality headset
  • Patients receiving pharmacological intervention to decrease preoperative anxiety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tablet study group
Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.
Behavioral: Separation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
Active Comparator: VR study group
Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.
Behavioral: Separation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient anxiety at the time of separation in children before surgical procedures
Time Frame: Preoperative Period
We will compare modified Yale Preoperative Anxiety Scale (mYPAS) scores between the tablet based distraction group to those in virtual reality group. The mYPAS evaluates 27 items divided into 5 categories: activity, vocalization, emotional expressivity, state of arousal, and use of parent. The score ranges from 23 (low anxiety) to 100 (high anxiety).
Preoperative Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
additional anxiety scoring techniques
Time Frame: Preoperative period
Short State-Trait Anxiety Inventory for Adults (STAI). The STAI is a validated self-evaluation questionnaire measuring anxiety with scores ranging from 6 (not at all) to 24 (very much).
Preoperative period
Mask acceptance by the patient
Time Frame: Intraoperative period
Mask Acceptance Scores
Intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Elizabeth Ghazal, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2018

Primary Completion (Actual)

April 2, 2020

Study Completion (Actual)

April 2, 2020

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5180036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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