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Stress, PsychologicalNCT02949401

Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

A study testing Use of Virtual Reality App in people with Stress, Psychological and Stress, Physiological, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 20 years
What is being tested?
Use of Virtual Reality App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2017to 16 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Pediatric Cardiology patients between the age of 10 and 20 years old
  • Undergoing cardiac electrophysiology procedure

Who cannot join

  • Inability to wear virtual reality glasses
  • Patients under 10 years old
  • Prior psychiatric illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University / Lucile Packard Children's Hospital

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Being tested
Use of Virtual Reality App
Keywords
Virtual Reality, Stress Inoculation, Procedure
Medical subject headings
Stress, Psychological, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of Virtual Reality AppBehavioural

    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).

Study groups in NCT02949401
Study groupRoleWhat they receive
Standard of CareNo interventionNo 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 RealityExperimentalThe 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.
Receives: Behavioral: Use of Virtual Reality App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).

    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.

    Measured: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure

Secondary outcomes (6)

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

    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.

    Measured: At time of recruitment, day of procedure

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

    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.

    Measured: At time of recruitment and 4 weeks post procedure

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

    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.

    Measured: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure

  4. Change in salivary cortisol levels from baseline in patients

    Measured: 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

    Measured: Day of procedure

  6. blood pressure in patients

    Measured: Day of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion16 Apr 2018
  4. Study completion16 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949401
Sponsor's protocol ID
37603
Status last verified
Mar 2019
First submitted
19 Oct 2016
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kain ZN, Caramico LA, Mayes LC, Genevro JL, Bornstein MH, Hofstadter MB. Preoperative preparation programs in children: a comparative examination. Anesth Analg. 1998 Dec;87(6):1249-55. doi: 10.1097/00000539-199812000-00007.

    PubMed 9842807

  • Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

    PubMed 8953995

  • Pallavicini F, Gaggioli A, Raspelli S, Cipresso P, Serino S, Vigna C, Grassi A, Morganti L, Baruffi M, Wiederhold B, Riva G. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial. Trials. 2013 Jun 28;14:191. doi: 10.1186/1745-6215-14-191.

    PubMed 23806013

  • Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.

    PubMed 16640481

  • Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Oncol Nurs Forum. 2002 Jan-Feb;29(1):E8-E15. doi: 10.1188/02.ONF.E8-E15.

    PubMed 11845217

  • Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.

    PubMed 20199609

  • Folstein MF, Luria R. Reliability, validity, and clinical application of the Visual Analogue Mood Scale. Psychol Med. 1973 Nov;3(4):479-86. doi: 10.1017/s0033291700054283. No abstract available.

    PubMed 4762224

  • Davey HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol. 2007 Apr;60(4):356-60. doi: 10.1016/j.jclinepi.2006.07.015. Epub 2006 Dec 27.

    PubMed 17346609

  • Tunc-Tuna P, Acikgoz A. The Effect of Preintervention Preparation on Pain and Anxiety Related to Peripheral Cannulation Procedures in Children. Pain Manag Nurs. 2015 Dec;16(6):846-54. doi: 10.1016/j.pmn.2015.06.006. Epub 2015 Aug 17.

    PubMed 26293196

Questions about this trial

What is this clinical trial studying?

A study testing Use of Virtual Reality App in people with Stress, Psychological and Stress, Physiological, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02949401, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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