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Completed

NCT Number: NCT03172182

Perioperative Effects of Operating Room Virtual Tour

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.

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Key information

Conditions

Preoperative Care Anxiety Anxiety Disorders Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a 360-degree VR video tour

Behavioral

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 outcomes

  1. Emergence delirium

    Time frame: At 5 minutes after arrival in post-anesthesia care unit (PACU)

    Pediatric Anesthesia Emergence Delirium (PAED) scale

Secondary outcomes

  1. 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. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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