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Perioperative Effects of Operating Room Virtual Tour

Primary Purpose

Preoperative Care, Anxiety, Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
a 360-degree VR video tour
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preoperative Care

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality (VR) group

Control Group

Arm Description

Immersive education using a 360-degree VR video tour at operation day

Conventional verbal education of preoperative proceudres

Outcomes

Primary Outcome Measures

Emergence delirium
Pediatric Anesthesia Emergence Delirium (PAED) scale

Secondary Outcome Measures

Preoperative anxiety
Modified Yale Preoperative Anxiety Scale (mYPAS)
Postoperative behavioral change
Hospitalization Post- Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

Full Information

First Posted
May 29, 2017
Last Updated
March 17, 2020
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03172182
Brief Title
Perioperative Effects of Operating Room Virtual Tour
Official Title
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
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
October 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Care, Anxiety, Emergence Delirium, Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality (VR) group
Arm Type
Experimental
Arm Description
Immersive education using a 360-degree VR video tour at operation day
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Conventional verbal education of preoperative proceudres
Intervention Type
Behavioral
Intervention Name(s)
a 360-degree VR video tour
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emergence delirium
Description
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time Frame
At 5 minutes after arrival in post-anesthesia care unit (PACU)
Secondary Outcome Measure Information:
Title
Preoperative anxiety
Description
Modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame
2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative)
Title
Postoperative behavioral change
Description
Hospitalization Post- Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)
Time Frame
2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Hee Han, MD/PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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Perioperative Effects of Operating Room Virtual Tour

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