Perioperative Effects of Operating Room Virtual Tour

Not Applicable

Completed

• Conditions: Anxiety; Preoperative Care; Emergence Delirium; Postoperative Complications
• Interventions: Behavioral: a 360-degree VR video tour

• Registration Number: NCT03172182
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-08-01
• Primary Completion: 2017-09-27
• Study Completion: 2017-10-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality (VR) group	a 360-degree VR video tour	Immersive education using a 360-degree VR video tour at operation day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Preoperative anxiety	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	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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of