AzTrials
AzTrials

Preoperative CareNCT03172182

Perioperative Effects of Operating Room Virtual Tour

A study testing a 360-degree VR video tour in people with Preoperative Care and Anxiety, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 10 years
Conditions the study is for
Preoperative Care, Anxiety, Emergence Delirium
What is being tested?
a 360-degree VR video tour
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteSouth Korea
Study dates
1 Aug 2017to 11 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

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

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.

Being tested
a 360-degree VR video tour
Medical subject headings
Anxiety Disorders, Emergence Delirium, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a 360-degree VR video tourBehavioural

    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.

Study groups in NCT03172182
Study groupRoleWhat they receive
Virtual reality (VR) groupExperimentalImmersive education using a 360-degree VR video tour at operation day
Receives: Behavioral: a 360-degree VR video tour
Control GroupNo interventionConventional verbal education of preoperative proceudres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emergence delirium

    Pediatric Anesthesia Emergence Delirium (PAED) scale

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

Secondary outcomes (2)

  1. Preoperative anxiety

    Modified Yale Preoperative Anxiety Scale (mYPAS)

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

  2. Postoperative behavioral change

    Hospitalization Post- Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2017
  2. Study start1 Aug 2017
  3. Primary completion27 Sep 2017
  4. Study completion11 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03172182
Sponsor's protocol ID
B-1705-396-302
Status last verified
Mar 2020
First submitted
29 May 2017
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moura LA, Dias IM, Pereira LV. Prevalence and factors associated with preoperative anxiety in children aged 5-12 years. Rev Lat Am Enfermagem. 2016 Jun 14;24:e2708. doi: 10.1590/1518-8345.0723.2708.

    PubMed 27305179

  • Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F. Predictors of preoperative anxiety in children. Anaesth Intensive Care. 2003 Feb;31(1):69-74. doi: 10.1177/0310057X0303100114.

    PubMed 12635399

  • Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

    PubMed 16882820

  • Thompson RH, Vernon DT. Research on children's behavior after hospitalization: a review and synthesis. J Dev Behav Pediatr. 1993 Feb;14(1):28-35.

    PubMed 8432876

  • Chrousos GP, Gold PW. The concepts of stress and stress system disorders. Overview of physical and behavioral homeostasis. JAMA. 1992 Mar 4;267(9):1244-52.

    PubMed 1538563

  • 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.

    PubMed 8953995

  • 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.

    PubMed 17578463

  • 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.

    PubMed 25992332

  • Rice M, Glasper A, Keeton D, Spargo P. The effect of a preoperative education programme on perioperative anxiety in children: an observational study. Paediatr Anaesth. 2008 May;18(5):426-30. doi: 10.1111/j.1460-9592.2008.02490.x.

    PubMed 18384339

  • 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.

    PubMed 26473103

  • 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.

    PubMed 24257388

  • 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.

    PubMed 27294708

  • 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.

    PubMed 26476281

  • 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.

    PubMed 26444149

  • Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

    PubMed 15114210

Questions about this trial

What is this clinical trial studying?

A study testing a 360-degree VR video tour in people with Preoperative Care and Anxiety, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergence delirium (time frame: At 5 minutes after arrival in post-anesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03172182, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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