Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

Anxiety Clinical Trial

Official title:

Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949401
• Other study ID #: 37603
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: March 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain Perception
• Stress, Physiological
• Stress, Psychological

Intervention

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).

Locations

Country	Name	City	State
United States	Stanford University / Lucile Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Epub 2006 Dec 27. — View Citation

Folstein MF, Luria R. Reliability, validity, and clinical application of the Visual Analogue Mood Scale. Psychol Med. 1973 Nov;3(4):479-86. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Tunç-Tuna P, Açikgoz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At time of recruitment, day of procedure
Secondary	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.	At time of recruitment and 4 weeks post procedure
Secondary	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.	At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
Secondary	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
Secondary	Heart rate in patients		Day of procedure
Secondary	blood pressure in patients		Day of procedure