Clinical trial NCT03172182: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Care
Anxiety
Emergence Delirium
Postoperative Complications
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 86
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Emergence delirium
timeFrame: At 5 minutes after arrival in post-anesthesia care unit (PACU)
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: 2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative)
measure: Postoperative behavioral change
timeFrame: 2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sung-Hee Han, MD/PhD
role: PRINCIPAL_INVESTIGATOR
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