Clinical trial NCT02949401: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress, Physiological
Anxiety
Pain Perception
Keywords: Virtual Reality
Stress Inoculation
Procedure
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
timeFrame: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
Secondary outcomes:
measure: Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety
timeFrame: At time of recruitment, day of procedure
measure: Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)
timeFrame: At time of recruitment and 4 weeks post procedure
measure: Change in anxiety levels from baseline in parents as measured by parental STAI
timeFrame: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
measure: Change in salivary cortisol levels from baseline in patients
timeFrame: 1 week before procedure (before use of VR), Day of pre-op, Day of procedure, Day after procedure or immediately after procedure if outpatient
measure: Heart rate in patients
timeFrame: Day of procedure
measure: blood pressure in patients
timeFrame: Day of procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University / Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Anne Dubin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Lauren Schneider, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Danton Char, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.