Perioperative Effects of Operating Room Virtual Tour

Study Overview
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Brief Summary
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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.

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

Conditions
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Preoperative Care, Anxiety, Emergence Delirium, Postoperative Complications

Intervention / Treatment
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* Behavioral: a 360-degree VR video tour


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality (VR) group<br>Immersive education using a 360-degree VR video tour at operation day | Behavioral: a 360-degree VR video tour<br>* 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.<br>|
| No Intervention: Control Group<br>Conventional verbal education of preoperative proceudres | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence delirium | Pediatric Anesthesia Emergence Delirium (PAED) scale | At 5 minutes after arrival in post-anesthesia care unit (PACU) | 

Secondary Outcome Measures

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