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Completed

NCT Number: NCT02949401

Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

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.

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Key information

Conditions

Stress, Psychological Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Pain Perception Stress, Physiological

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University / Lucile Packard Children's Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Virtual Reality App

Behavioral

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).

Primary outcomes

  1. 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

  1. Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety

    Time frame: 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.

  2. Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)

    Time frame: 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.

  3. Change in anxiety levels from baseline in parents as measured by parental 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.

  4. Change in salivary cortisol levels from baseline in patients

    Time frame: 1 week before procedure (before use of VR), Day of pre-op, Day of procedure, Day after procedure or immediately after procedure if outpatient

  5. Heart rate in patients

    Time frame: Day of procedure

  6. blood pressure in patients

    Time frame: Day of procedure

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2016
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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