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Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

Primary Purpose

Stress, Psychological, Stress, Physiological, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of Virtual Reality App
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Virtual Reality, Stress Inoculation, Procedure

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University / Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Virtual Reality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
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.

Secondary Outcome Measures

Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety
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.
Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)
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.
Change in anxiety levels from baseline in parents as measured by parental STAI
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.
Change in salivary cortisol levels from baseline in patients
Heart rate in patients
blood pressure in patients

Full Information

First Posted
October 19, 2016
Last Updated
March 18, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02949401
Brief Title
Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory
Official Title
Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological, Anxiety, Pain Perception
Keywords
Virtual Reality, Stress Inoculation, Procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Use of Virtual Reality App
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
Description
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.
Time Frame
At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
Secondary Outcome Measure Information:
Title
Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety
Description
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.
Time Frame
At time of recruitment, day of procedure
Title
Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)
Description
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.
Time Frame
At time of recruitment and 4 weeks post procedure
Title
Change in anxiety levels from baseline in parents as measured by parental STAI
Description
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.
Time Frame
At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
Title
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
Title
Heart rate in patients
Time Frame
Day of procedure
Title
blood pressure in patients
Time Frame
Day of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Dubin, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Schneider, PsyD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Danton Char, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University / Lucile Packard Children's Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9842807
Citation
Kain ZN, Caramico LA, Mayes LC, Genevro JL, Bornstein MH, Hofstadter MB. Preoperative preparation programs in children: a comparative examination. Anesth Analg. 1998 Dec;87(6):1249-55. doi: 10.1097/00000539-199812000-00007.
Results Reference
background
PubMed Identifier
8953995
Citation
Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
Results Reference
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PubMed Identifier
23806013
Citation
Pallavicini F, Gaggioli A, Raspelli S, Cipresso P, Serino S, Vigna C, Grassi A, Morganti L, Baruffi M, Wiederhold B, Riva G. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial. Trials. 2013 Jun 28;14:191. doi: 10.1186/1745-6215-14-191.
Results Reference
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PubMed Identifier
16640481
Citation
Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
Results Reference
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PubMed Identifier
11845217
Citation
Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Oncol Nurs Forum. 2002 Jan-Feb;29(1):E8-E15. doi: 10.1188/02.ONF.E8-E15.
Results Reference
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PubMed Identifier
20199609
Citation
Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.
Results Reference
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PubMed Identifier
4762224
Citation
Folstein MF, Luria R. Reliability, validity, and clinical application of the Visual Analogue Mood Scale. Psychol Med. 1973 Nov;3(4):479-86. doi: 10.1017/s0033291700054283. No abstract available.
Results Reference
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PubMed Identifier
17346609
Citation
Davey HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol. 2007 Apr;60(4):356-60. doi: 10.1016/j.jclinepi.2006.07.015. Epub 2006 Dec 27.
Results Reference
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PubMed Identifier
26293196
Citation
Tunc-Tuna P, Acikgoz A. The Effect of Preintervention Preparation on Pain and Anxiety Related to Peripheral Cannulation Procedures in Children. Pain Manag Nurs. 2015 Dec;16(6):846-54. doi: 10.1016/j.pmn.2015.06.006. Epub 2015 Aug 17.
Results Reference
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Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

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