Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

NCT02949401 | Completed

• 1 other identifier: 37603
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Stress, Physiological; Anxiety; Pain Perception

Keywords

Virtual Reality; Stress Inoculation; Procedure

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure

Secondary Outcomes (6)

• Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety

  At time of recruitment, day of procedure

• Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)

  At time of recruitment and 4 weeks post procedure

• Change in anxiety levels from baseline in parents as measured by parental STAI

  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

  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

  Day of procedure

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Virtual Reality

EXPERIMENTAL

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

Interventions

Use of Virtual Reality App BEHAVIORAL

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).

Virtual Reality

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University / Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Related Publications (9)

• 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.

  PMID: 9842807 BACKGROUND

• 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.

  PMID: 8953995 BACKGROUND

• 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.

  PMID: 23806013 BACKGROUND

• 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.

  PMID: 16640481 BACKGROUND

• 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.

  PMID: 11845217 BACKGROUND

• 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.

  PMID: 20199609 BACKGROUND

• 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.

  PMID: 4762224 BACKGROUND

• 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.

  PMID: 17346609 BACKGROUND

• 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.

  PMID: 26293196 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Anne Dubin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Lauren Schneider, PsyD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Danton Char, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 31, 2016
• Study Start: January 1, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)