Perioperative Effects of Operating Room Virtual Tour

March 17, 2020 updated by: Sung-Hee Han, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence delirium
Time Frame: At 5 minutes after arrival in post-anesthesia care unit (PACU)
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
Time Frame: 2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative)
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
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)
2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Sung-Hee Han, MD/PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

September 27, 2017

Study Completion (Actual)

October 11, 2017

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

May 29, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1705-396-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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