Anxiety, Pain Perception, Stress, Physiological, Stress, Psychological
Conditions
Keywords
Virtual Reality, Stress Inoculation, Procedure
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.
Interventions
BEHAVIORALUse 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).
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI). | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety | At time of recruitment, day of procedure | 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. |
| Heart rate in patients | Day of procedure | — |
| blood pressure in patients | 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 | — |
Countries
United States
Outcome results
None listed