Study Results
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Basic Information
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SUSPENDED
NA
450 participants
INTERVENTIONAL
2015-12-04
2026-12-06
Brief Summary
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Detailed Description
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The current study aims to: 1) Determine if VR is more effective than standard care for preventing anxiety, distress, and pain before surgery among children undergoing anesthesia induction, 2) To evaluate healthcare provider's and caregiver's assessment of patient cooperation and caregiver's distress and satisfaction with VR compared to standard of care, and 3) to explore the influence of patient and caregiver characteristics on the effectiveness of VR in preventing pre-operative anxiety and distress and subsequent post-operative outcomes.
Study Population: Children (age 10 - 21 years) and their parents who are scheduled to undergo outpatient surgery, whose health status is American Society of Anesthesiologists (ASA) physical status I-III, and are in the normal range of development are eligible to be in the study.
Study Methodology: The study is a randomized, controlled trial designed to examine the effects of VR on the level of preoperative pain, anxiety and distress of children undergoing surgery.
Statistical Analyses: Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available. Univariate ANOVA will be used to compare conditions on post-operative variables. Multiple regression analyses will be used to examine the influence of patient and caregiver variables on patient outcomes in the VR group only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard of Care (No VR) Randomization
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for IV placement and induction of anesthesia. Current standard of care practices at CHLA for outpatient surgery induction will include the following steps. Children may receive midazolam, parental presence during induction and any other intervention or medication chosen by the HCP. The research team will have no input to the decision regarding the use of any therapy.
No interventions assigned to this group
VR Randomization
When a child is assigned to the VR condition s/he will have the added component of VR distraction during pre-surgical preparation. Children in the VR condition will interact with an immersive 3D virtual environment presented via a HMD (head-mounted display), a helmet with computer screens for each eye. This study will use two HMDs at two possible time points: (1) Prior to and during IV placement, participants will play using the Oculus Go; (2) Prior to and during anesthesia induction, participants will play using the Mira Prism.
Oculus Go VR
The Oculus Go is a standalone headset with built-in speakers that runs independently of a smartphone. Via the Oculus Go, participants will engage with BearBlast (developed by AppliedVR). Throughout the world, plush moles play the role of antagonist, standing in for the nuisance and distraction of pain. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. The VR HMD runs independently of a smartphone and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
Mira Prism VR
The Mira Prism is a portable, augmented reality (AR) HMD powered by iPhone. When paired with the iPhone, the Mira Prism goggles can superimpose computer-generated images on the user's view of the real world. Unlike the full immersion of VR, AR allows users to view the outside world while interacting with digital content. In this study, the patient will interact with Magic Mallet (developed by Miney Moe) until falling asleep during the anesthesia induction process. Magic Mallet is a distraction game designed for pain management and communication during procedures. The game automatically adjusts cognitive load for optimal effect for users. Study team iPhones specifically loaded with Magic Mallet, and without cellular capability, will be used with the Mira Prism.
Interventions
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Oculus Go VR
The Oculus Go is a standalone headset with built-in speakers that runs independently of a smartphone. Via the Oculus Go, participants will engage with BearBlast (developed by AppliedVR). Throughout the world, plush moles play the role of antagonist, standing in for the nuisance and distraction of pain. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. The VR HMD runs independently of a smartphone and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
Mira Prism VR
The Mira Prism is a portable, augmented reality (AR) HMD powered by iPhone. When paired with the iPhone, the Mira Prism goggles can superimpose computer-generated images on the user's view of the real world. Unlike the full immersion of VR, AR allows users to view the outside world while interacting with digital content. In this study, the patient will interact with Magic Mallet (developed by Miney Moe) until falling asleep during the anesthesia induction process. Magic Mallet is a distraction game designed for pain management and communication during procedures. The game automatically adjusts cognitive load for optimal effect for users. Study team iPhones specifically loaded with Magic Mallet, and without cellular capability, will be used with the Mira Prism.
Eligibility Criteria
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Inclusion Criteria
* Children who are English speaking (parents may be Spanish English speaking or Spanish speaking)
* Children who are scheduled to undergo outpatient surgery are eligible to participate in this project.
* Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to patients who are normal and healthy with no known systemic disease. ASA status II refers to patients who have mild or well-controlled systemic diseases, such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies.
* Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the preparation programs and interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
Exclusion Criteria
* Children who are taking psychotropic medications that affect emotion modulation will be excluded from this study.
* Children with organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
* Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks or use the technological devices
* Children with a history of seizure disorder.
* Children currently sick with flu-like symptoms or experiencing a headache or earache
10 Years
21 Years
ALL
Yes
Sponsors
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AppliedVR Inc.
INDUSTRY
Children's Hospital Los Angeles
OTHER
Responsible Party
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Jeffrey I Gold, PhD
Professor of Anesthesiology, Pediatrics, and Psychiatry & Behavioral Sciences
Principal Investigators
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Jeffrey I Gold, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Countries
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References
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Perry JN, Hooper VD, Masiongale J. Reduction of preoperative anxiety in pediatric surgery patients using age-appropriate teaching interventions. J Perianesth Nurs. 2012 Apr;27(2):69-81. doi: 10.1016/j.jopan.2012.01.003.
Davidson A, McKenzie I. Distress at induction: prevention and consequences. Curr Opin Anaesthesiol. 2011 Jun;24(3):301-6. doi: 10.1097/ACO.0b013e3283466b27.
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.
Kain Z, Lc M, Cote C, Todres D: The perioperative behavioral stress response in children, Practice of Anesthesia for Infants and Children. Edited by Anonymous. Philadelphia, W.B. Saunders, 2001, pp 25-37.
Kain Z, Mayes L, Borestein M, Genevro J: Anxiety in children during the perioperative period, Child Development and Behavioral Pediatrics. Edited by Anonymous. Mahwah, NJ, Lawrence Erlbaum Associates, 1996, pp 85-103.
Burton L, Verma V: Anxiety relating to illness and treatment, Anxiety in Children. Edited by Anonymous. New York, Methuen Croom Helm, 1984, pp 151-172.
Kain Z, Atlee J: Perioperative psychological trauma in children, Complications in Anesthesiology. Edited by Anonymous. Philadelphia, WB Saunders, 1999, pp 674-677.
Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
Kain Z, Sevarino F, Rinder C: The preoperative behavioral stress response: Does it exist? Anesthesiology 1999; 91: A742.
Kiecolt-Glaser JK, Page GG, Marucha PT, MacCallum RC, Glaser R. Psychological influences on surgical recovery. Perspectives from psychoneuroimmunology. Am Psychol. 1998 Nov;53(11):1209-18. doi: 10.1037//0003-066x.53.11.1209.
Johnston M. Pre-operative emotional states and post-operative recovery. Adv Psychosom Med. 1986;15:1-22. doi: 10.1159/000411845. No abstract available.
Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res. 2000 Dec;49(6):417-22. doi: 10.1016/s0022-3999(00)00189-6.
Martinez-Urrutia A. Anxiety and pain in surgical patients. J Consult Clin Psychol. 1975 Aug;43(4):437-42. doi: 10.1037/h0076898. No abstract available.
Wallace LM. Pre-operative state anxiety as a mediator of psychological adjustment to and recovery from surgery. Br J Med Psychol. 1986 Sep;59(3):253-61. doi: 10.1111/j.2044-8341.1986.tb02691.x.
Kain ZN. Premedication and parental presence revisited. Curr Opin Anaesthesiol. 2001 Jun;14(3):331-7. doi: 10.1097/00001503-200106000-00009.
Kain ZN, Caldwell-Andrews AA, LoDolce ME, Krivutza DM, Wang SM: The Perioperative Behavioral Stress Response in Children. Anesthesiology 2002; 96: A1242.
Viitanen H, Annila P, Viitanen M, Tarkkila P. Premedication with midazolam delays recovery after ambulatory sevoflurane anesthesia in children. Anesth Analg. 1999 Jul;89(1):75-9. doi: 10.1097/00000539-199907000-00014.
Viitanen H, Annila P, Viitanen M, Yli-Hankala A. Midazolam premedication delays recovery from propofol-induced sevoflurane anesthesia in children 1-3 yr. Can J Anaesth. 1999 Aug;46(8):766-71. doi: 10.1007/BF03013912.
Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.
Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
Reger, G. M., A. A. Rizzo, J. G. Buckwalter, J. Gold, R. Allen, R. Augustine, and E. Mendelowitz.
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.
Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.
Faber AW, Patterson DR, Bremer M. Repeated use of immersive virtual reality therapy to control pain during wound dressing changes in pediatric and adult burn patients. J Burn Care Res. 2013 Sep-Oct;34(5):563-8. doi: 10.1097/BCR.0b013e3182777904.
Kipping B, Rodger S, Miller K, Kimble RM. Virtual reality for acute pain reduction in adolescents undergoing burn wound care: a prospective randomized controlled trial. Burns. 2012 Aug;38(5):650-7. doi: 10.1016/j.burns.2011.11.010. Epub 2012 Feb 18.
Schneider SM, Workman ML. Effects of virtual reality on symptom distress in children receiving chemotherapy. Cyberpsychol Behav. 1999;2(2):125-34. doi: 10.1089/cpb.1999.2.125.
Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Apr;117(4):1162-8. doi: 10.1542/peds.2005-1100.
Mosso-Vazquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371-8. doi: 10.1089/cyber.2014.0198.
Dahlquist LM, Weiss KE, Clendaniel LD, Law EF, Ackerman CS, McKenna KD. Effects of videogame distraction using a virtual reality type head-mounted display helmet on cold pressor pain in children. J Pediatr Psychol. 2009 Jun;34(5):574-84. doi: 10.1093/jpepsy/jsn023. Epub 2008 Mar 26.
Dahlquist LM, McKenna KD, Jones KK, Dillinger L, Weiss KE, Ackerman CS. Active and passive distraction using a head-mounted display helmet: effects on cold pressor pain in children. Health Psychol. 2007 Nov;26(6):794-801. doi: 10.1037/0278-6133.26.6.794.
Other Identifiers
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CHLA-15-00461
Identifier Type: -
Identifier Source: org_study_id
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