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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality (VR) group | Experimental | Immersive education using a 360-degree VR video tour at operation day |
|
| Control Group | No Intervention | Conventional verbal education of preoperative proceudres |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence delirium | Pediatric Anesthesia Emergence Delirium (PAED) scale | At 5 minutes after arrival in post-anesthesia care unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative anxiety | Modified Yale Preoperative Anxiety Scale (mYPAS) | 2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative) |
| Postoperative behavioral change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Hee Han, MD/PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27305179 | Background | 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. | |
| 12635399 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2018 | Mar 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000071257 | Emergence Delirium |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
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|
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 |
| 16882820 | Background | 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. |
| 8432876 | Background | 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. |
| 1538563 | Background | 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. |
| 8953995 | 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. |
| 17578463 | 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. |
| 25992332 | 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. |
| 18384339 | Background | 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. |
| 26473103 | 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. |
| 24257388 | 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. |
| 27294708 | 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. |
| 26476281 | 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. |
| 26444149 | 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. |
| 15114210 | Background | 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. |
| 25958978 | 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. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |