Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

March 18, 2019 updated by: Anne M. Dubin, Stanford University
The goal of this study is to assess the utility of virtual reality technology to aid in the mental health of patients with cardiac disease, specifically looking at decreasing anxiety and perceptions of pain from stressful procedures in the pediatric electrophysiology laboratory.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will perform a pilot study of 40 patients who are randomized to either standard of care preparation for an electrophysiology procedure (control arm) vs. Virtual Reality preparation (VR arm). Participants in control arm will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time. VR arm participants will have access to the Virtual Reality tour and gear 1 week prior to the procedure. VR arm participants will be instructed to watch the Virtual Reality tour at least three times prior to the procedure but will be encouraged to watch as often as the participants would like. The Virtual Reality equipment will measure how often participants complete the tour. All participants will undergo anxiety measures a total of four times: once at time of recruitment, day of procedure and then 1 week and 4 weeks post procedure. Participants will have cortisol salivary swabs performed 1 week before procedure (before VR use), pre-op visit, day of procedure, and immediately following procedure. Heart rate and blood pressure will be measured on day of procedure.

Study Type

Interventional

Enrollment (Actual)

40

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, 94305
        • Stanford University / Lucile Packard 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

10 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric Cardiology patients between the age of 10 and 20 years old
  • Undergoing cardiac electrophysiology procedure

Exclusion Criteria:

  • Inability to wear virtual reality glasses
  • Patients under 10 years old
  • Prior psychiatric illness

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard of Care

No research intervention to be administered.

Participants will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time.
EXPERIMENTAL: Virtual Reality
The VR interactive module will consist of a 360° visit to the Hospital where patients encounter the various aspects of a procedure from the front door; through the pre-operative area where patients will receive an IV; to the catheterization lab and placement of the anesthesia mask; and back to the post anesthesia care unit. Patients will be accompanied by a child who acts as a guide to the experience. The guide will help explain what the patient is seeing and what to expect along the way. Health care professionals will be enmeshed within the scenarios and will also help with the explanations along the way. Patients will be prompted to enter the relaxation scenarios at different stressful times along the tour to practice relaxation and mindfulness techniques (i.e. before IV start, or upon entering catheterization laboratory). Relaxation scenarios will include a snow scene, tropical beach or other guided imagery scenes.
Behavioral: Use of Virtual Reality App
The VR app will consist of relaxation techniques as well as a virtual tour of the hospital (pre-op area, IV placement, cath lab, and post-op area).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
Time Frame: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
State -Trait Anxiety Inventory (STAI) is a widely used self-report measure that estimates situational (state) and baseline (trait) anxiety in adults and children. It is both valid and reliable and routinely used in measuring anxiety associated with medical procedures. The pediatric version is available for use with upper elementary, or junior high or high school aged children.
At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety
Time Frame: At time of recruitment, day of procedure
Visual Analog Scale of Anxiety (VAS) is a widely used self-reported and observational measure of anxiety. Patients place a vertical line along a 10 cm horizontal line which is anchored with the descriptors "not at all anxious" and "extremely anxious" and 10 markings 1 cm apart. This simple format of assessing anxiety is often used in operating rooms or before medical procedures given its brevity and ease of administration is fast-paced settings. It has been correlated with STAI scores.
At time of recruitment, day of procedure
Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)
Time Frame: At time of recruitment and 4 weeks post procedure
Child Behavior Checklist (CBCL) is a rating form of child behavior completed by parents. It has been developed for children aged 6-18 years. This checklist groups into sets of behaviors: internalizing, externalizing and total problems.
At time of recruitment and 4 weeks post procedure
Change in anxiety levels from baseline in parents as measured by parental STAI
Time Frame: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
State -Trait Anxiety Inventory (STAI) is a widely used self-report measure that estimates situational (state) and baseline (trait) anxiety in adults and children. It is both valid and reliable and routinely used in measuring anxiety associated with medical procedures.
At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
Change in salivary cortisol levels from baseline in patients
Time Frame: 1 week before procedure (before use of VR), Day of pre-op, Day of procedure, Day after procedure or immediately after procedure if outpatient
1 week before procedure (before use of VR), Day of pre-op, Day of procedure, Day after procedure or immediately after procedure if outpatient
Heart rate in patients
Time Frame: Day of procedure
Day of procedure
blood pressure in patients
Time Frame: Day of procedure
Day of procedure

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Anne Dubin, MD, Stanford University
  • Principal Investigator: Lauren Schneider, PsyD, Stanford University
  • Principal Investigator: Danton Char, MD, 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

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)

January 1, 2017

Primary Completion (ACTUAL)

April 16, 2018

Study Completion (ACTUAL)

April 16, 2018

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (ESTIMATE)

October 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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