Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

Stanford University

Status: Completed

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

Treatments: Behavioral: Use of Virtual Reality App

Study type: Interventional

Funder types: Other

Identifiers

NCT02949401

37603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 10 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Use of Virtual Reality App