Perioperative Effects of Operating Room Virtual Tour

NCT03172182 | Completed

• 1 other identifier: B-1705-396-302
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Care; Anxiety; Emergence Delirium; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Emergence delirium

  Pediatric Anesthesia Emergence Delirium (PAED) scale

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

Secondary Outcomes (2)

• Preoperative anxiety

  2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative)

• Postoperative behavioral change

  2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents

Study Arms (2)

Virtual reality (VR) group

EXPERIMENTAL

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

Behavioral: a 360-degree VR video tour

Control Group

NO INTERVENTION

Conventional verbal education of preoperative proceudres

Interventions

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.

Virtual reality (VR) group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (16)

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  PMID: 27305179 BACKGROUND

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  PMID: 12635399 BACKGROUND

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  PMID: 1538563 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• Arai YC, Ito H, Kandatsu N, Kurokawa S, Kinugasa S, Komatsu T. Parental presence during induction enhances the effect of oral midazolam on emergence behavior of children undergoing general anesthesia. Acta Anaesthesiol Scand. 2007 Aug;51(7):858-61. doi: 10.1111/j.1399-6576.2007.01339.x. Epub 2007 Jun 18.

  PMID: 17578463 BACKGROUND

• El Batawi HY. Effect of preoperative oral midazolam sedation on separation anxiety and emergence delirium among children undergoing dental treatment under general anesthesia. J Int Soc Prev Community Dent. 2015 Mar-Apr;5(2):88-94. doi: 10.4103/2231-0762.155728.

  PMID: 25992332 BACKGROUND

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  PMID: 18384339 BACKGROUND

• Sadegh Tabrizi J, Seyedhejazi M, Fakhari A, Ghadimi F, Hamidi M, Taghizadieh N. Preoperative Education and Decreasing Preoperative Anxiety Among Children Aged 8 - 10 Years Old and Their Mothers. Anesth Pain Med. 2015 Aug 22;5(4):e25036. doi: 10.5812/aapm.25036. eCollection 2015 Aug.

  PMID: 26473103 BACKGROUND

• Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.

  PMID: 24257388 BACKGROUND

• Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1.

  PMID: 27294708 BACKGROUND

• Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.

  PMID: 26476281 BACKGROUND

• Makkar JK, Bhatia N, Bala I, Dwivedi D, Singh PM. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia. 2016 Jan;71(1):50-7. doi: 10.1111/anae.13230. Epub 2015 Oct 7.

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  PMID: 15114210 BACKGROUND

• Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9.

  PMID: 25958978 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Emergence Delirium; Postoperative Complications

Condition Hierarchy (Ancestors)

Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Sung-Hee Han, MD/PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 1, 2017
• Study Start: August 1, 2017
• Primary Completion: September 27, 2017
• Study Completion: October 11, 2017
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)