Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress, Psychological
- Sponsor
- Stanford University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Anne M. Dubin
Professor of Pediatrics
Stanford University
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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 parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)(At time of recruitment and 4 weeks post procedure)
- Heart rate in patients(Day of procedure)
- 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 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)
- blood pressure in patients(Day of procedure)