Perioperative Effects of Operating Room Virtual Tour

Overview

Preoperative anxiety is associated with adverse consequences such as emergence delirium, and postoperative behavioral changes. According to previous studies, providing information of anesthetic procedures helps to lessen preoperative anxiety. However, verbal explanation alone provides the limited effect, and the tour program of the operating room prior to surgery may not be possible for a number of hospitals due to organizational and financial reasons. Therefore, the virtual reality (VR) tour of the operating room may be an innovative and novel method to give children information about the preoperative process and to alleviate the preoperative anxiety. In this study, we intend to evaluate the effects of the operating room virtual tour on preoperative anxiety as well as emergence delirium and postoperative behavioral changes, in pediatric patients.

Full Title of Study: “The Effects of Operating Room Virtual Tour on Preoperative Anxiety, Emergence Delirium and Postoperative Behavioral Changes of Pediatric Patients: Prospective, Randomized, and Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 27, 2017

Interventions

  • Behavioral: a 360-degree VR video tour
    • At operation day, pediatric patients of the VR group and their parents are educated using virtual tour program explaining preoperative procedures and showing environment of the operating room. A 360-degree virtual reality (VR) video for the tour program was filmed in advance and is provided using a head mount device into which a smartphone is installed, at 30 minutes before the induction of anesthesia.

Arms, Groups and Cohorts

  • Experimental: Virtual reality (VR) group
    • Immersive education using a 360-degree VR video tour at operation day
  • No Intervention: Control Group
    • Conventional verbal education of preoperative proceudres

Clinical Trial Outcome Measures

Primary Measures

  • Emergence delirium
    • Time Frame: At 5 minutes after arrival in post-anesthesia care unit (PACU)
    • Pediatric Anesthesia Emergence Delirium (PAED) scale

Secondary Measures

  • Preoperative anxiety
    • Time Frame: 2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative)
    • Modified Yale Preoperative Anxiety Scale (mYPAS)
  • Postoperative behavioral change
    • Time Frame: 2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents
    • Hospitalization Post- Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

Participating in This Clinical Trial

Inclusion Criteria

  • Elective surgery
  • American Society of Anesthesiologist (ASA) physical class I, II
  • Informed consent; Children aged between 4 and 6 years old are allowed to have verbal consent and their parents provide informed written consent. Children over the age of 7 are required to obtain a written consent with parental permission.

Exclusion Criteria

  • ASA class ≥ III
  • Major surgery needing postoperative intensive care unit (ICU) admission.
  • Chronic disease or history of preterm birth
  • Developmental delay
  • Hearing or vision impairment
  • Affective disorder
  • History of epilepsy or seizure
  • Previous experience of general anesthesia

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sung-Hee Han, Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Sung-Hee Han, MD/PhD, Principal Investigator, Seoul National University Bundang Hospital

References

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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. Review.

Makkar JK, Bhatia N, Bala I, Dwivedi D, Singh PM. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia. 2016 Jan;71(1):50-7. doi: 10.1111/anae.13230. Epub 2015 Oct 7.

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