Perioperative Effects of Operating Room Virtual Tour

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172182
• Other study ID #: B-1705-396-302
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: October 11, 2017

Study information

• Verified date: March 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 11, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Delirium
• Emergence Delirium
• Postoperative Complications
• Preoperative Care

Intervention

Behavioral:
• a 360-degree VR video tour
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (16)

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. Epub 2007 Jun 18. — View Citation

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. Review. — View Citation

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. Review. Erratum in: JAMA 1992 Jul 8;268(2):200. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. pii: S0104-11692016000100339. doi: 10.1590/1518-8345.0723.2708. English, Portuguese, Spanish. — View Citation

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. — View Citation

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. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence delirium	Pediatric Anesthesia Emergence Delirium (PAED) scale	At 5 minutes after arrival in post-anesthesia care unit (PACU)
Secondary	Preoperative anxiety	Modified Yale Preoperative Anxiety Scale (mYPAS)	2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative)
Secondary	Postoperative behavioral change	Hospitalization Post- Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)	2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents