Anxiety Clinical Trial
Official title:
Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory
NCT number | NCT02949401 |
Other study ID # | 37603 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | April 16, 2018 |
Verified date | March 2019 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 16, 2018 |
Est. primary completion date | April 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 20 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University / Lucile Packard Children's Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
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. Epub 2006 Dec 27. — View Citation
Folstein MF, Luria R. Reliability, validity, and clinical application of the Visual Analogue Mood Scale. Psychol Med. 1973 Nov;3(4):479-86. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Tunç-Tuna P, Açikgoz 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure | |
Secondary | 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. | At time of recruitment, day of procedure | |
Secondary | 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. | At time of recruitment and 4 weeks post procedure | |
Secondary | 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. | At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure | |
Secondary | 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 | ||
Secondary | Heart rate in patients | Day of procedure | ||
Secondary | blood pressure in patients | Day of procedure |
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