Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children

January 29, 2024 updated by: Thomas Caruso, Stanford University
This is an experimental study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers (e.g., parents, guardians)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hospitalized pediatric patients, especially those undergoing anesthesia and surgery, experience anxiety and fear, resulting in lack of cooperation, withdrawal, and aggression. These reactions delay medical care and negatively impact patient experience.

This is an experimental, prospective study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers. The primary center for this study will be Lucile Packard Children's Hospital Stanford (LPCHS) (located within Stanford University, Palo Alto, CA).

After software development, we will evaluate the awe and engagement of pediatric patients after experiencing the novel virtual reality application.

Study Type

Interventional

Enrollment (Actual)

202

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
      • Stanford, California, United States, 94304
        • Lucile Parkard Children's Hospital

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

6 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with age range from 6 to 25
  • Adult or LAR with age range from 18 to 99
  • Able to consent or have parental consent
  • in pre-operative holding and inpatient acute care areas of LCPH
  • English speaking participants

Exclusion Criteria:

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Visual Problems
  • currently have nausea
  • history of seizures
  • non-english participants

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Virtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds.
Behavioral: Virtual Reality
Virtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds. Participants will be asked to fill out a survey before the intervention to collect the baseline data, after each session of VR intervention and a final survey at the end of the study.
Other: Control
Participants will serve as their own controls. Participants will not be given any VR intervention at first but they are requested to fill out the survey to collect the baseline data.
Other: Control
For case control, participants will service as their self control and no VR intervention will be given at first. Participants will be asked to fill out a survey before the intervention to collect the baseline data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in awe levels measured by Global Perceived Awe Survey
Time Frame: Duration of intervention, approximately 20-30 minutes
Global Perceived Awe Survey contains an 7-point Likert scale . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Duration of intervention, approximately 20-30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in awe levels measured by Perceived Need for Accommodation Survey
Time Frame: Duration of intervention, approximately 20-30 minutes
Perceived Need for Accommodation Survey contains 3 items . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Duration of intervention, approximately 20-30 minutes
Change in awe levels measured by Perceived Vastness Survey
Time Frame: Duration of intervention, approximately 20-30 minutes
Perceived Vastness Survey contains 4 items . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Duration of intervention, approximately 20-30 minutes
Change in engagement measured by Game Engagement Questionnaire
Time Frame: Duration of intervention, approximately 20-30 minutes
Game Engagement Questionnaire contains 19 items . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Duration of intervention, approximately 20-30 minutes

Collaborators and Investigators

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

Sponsor

Stanford 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

Helpful Links

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)

June 29, 2023

Primary Completion (Actual)

August 3, 2023

Study Completion (Actual)

August 3, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69170

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.

Clinical Trials on Awe

Clinical Trials on Virtual Reality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe