NCT02949401

Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-04-16
• Completion: 2018-04-16
• First posted: 2016-10-31
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States