Comparison of Virtual Reality to Tablet-based Distraction in Children
NCT ID: NCT04414501
Last Updated: 2021-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2018-04-30
2020-04-02
Brief Summary
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Detailed Description
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The study group was given a Virtual Reality Smartphone headset in the preoperative holding area prior to transport to the operating room. This headset was chosen because of its low cost and wide compatibility for a variety of smartphones. The content consisted of several VR environments that the child/parent could choose from.
In both groups, the distraction with tablet or VR was continued throughout separation from caregivers, transport to the operating room, placement of monitors and mask induction of general anesthesia. Anxiety at time of separation was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was determined by using the Mask Acceptance Scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tablet study group
Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.
Separation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
VR study group
Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.
Separation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
Interventions
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Separation Anxiety
Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
Eligibility Criteria
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Inclusion Criteria
* Undergoing procedure that requires general anesthesia
Exclusion Criteria
* ASA III-IV
* Patients with facial skin lesions
* Patients with significant history of motion sickness
* Visually impaired patients
* Patients unable to wear a virtual reality headset
* Patients receiving pharmacological intervention to decrease preoperative anxiety
4 Years
10 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Elizabeth Ghazal
Associate Professor
Principal Investigators
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Elizabeth Ghazal, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Countries
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References
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Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.
Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100.
Esteve R, Marquina-Aponte V, Ramirez-Maestre C. Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers' responses to children's pain. J Pain. 2014 Feb;15(2):157-68.e1. doi: 10.1016/j.jpain.2013.10.007. Epub 2013 Oct 27.
Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
Yang KS, Habib AS, Lu M, Branch MS, Muir H, Manberg P, Sigl JC, Gan TJ. A prospective evaluation of the incidence of adverse events in nurse-administered moderate sedation guided by sedation scores or Bispectral Index. Anesth Analg. 2014 Jul;119(1):43-48. doi: 10.1213/ANE.0b013e3182a125c3.
Weiss KE, Dahlquist LM, Wohlheiter K. The effects of interactive and passive distraction on cold pressor pain in preschool-aged children. J Pediatr Psychol. 2011 Aug;36(7):816-26. doi: 10.1093/jpepsy/jsq125. Epub 2011 Jan 29.
Wohlheiter KA, Dahlquist LM. Interactive versus passive distraction for acute pain management in young children: the role of selective attention and development. J Pediatr Psychol. 2013 Mar;38(2):202-12. doi: 10.1093/jpepsy/jss108. Epub 2012 Oct 23.
Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.
Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
Cox RG, Nemish U, Ewen A, Crowe MJ. Evidence-based clinical update: does premedication with oral midazolam lead to improved behavioural outcomes in children? Can J Anaesth. 2006 Dec;53(12):1213-9. doi: 10.1007/BF03021583.
Spielberger CD, Vagg PR. Psychometric properties of the STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers Assess. 1984 Feb;48(1):95-7. doi: 10.1207/s15327752jpa4801_16. No abstract available.
Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
Other Identifiers
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5180036
Identifier Type: -
Identifier Source: org_study_id
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