Anxiety Clinical Trial
Official title:
Pediatric Procedural Sedation and the Relationship With Post-Discharge Negative Behavioral Changes in the Emergency Department
NCT number | NCT03980067 |
Other study ID # | 1300058-5 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2019 |
Est. completion date | May 12, 2022 |
Verified date | January 2023 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate if a virtual reality (VR) distraction game played prior to procedural sedation for long bone fracture reduction will improve post-discharge negative behavior changes following discharge from the pediatric Emergency Department (ED).
Status | Completed |
Enrollment | 201 |
Est. completion date | May 12, 2022 |
Est. primary completion date | May 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: - Children ages 6 years to 17.5 years old receiving procedural sedation with IV ketamine in the Children's Hospital of Wisconsin Emergency Department for long bone fracture reduction Exclusion Criteria: - Moderate to severe developmental delay - Non-English-speaking participants or parent/guardian - Taking psychotropic medications - History of severe motion sickness - Currently experiencing nausea/vomiting - History of severe visual impairment - History of seizures - Expected admission to the hospital post-procedure |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12. — View Citation
Brodzinski H, Iyer S. Behavior changes after minor emergency procedures. Pediatr Emerg Care. 2013 Oct;29(10):1098-101. doi: 10.1097/PEC.0b013e3182a5ff07. — View Citation
CHARIOT Program - Childhood Anxiety Reduction through Innovation and Technology - Stanford Children's Health. (n.d.). Retrieved August 7, 2018, from https://www.stanfordchildrens.org/en/innovation/chariot
Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350. — 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, Caldwell-Andrews AA, Maranets I, Nelson W, Mayes LC. Predicting which child-parent pair will benefit from parental presence during induction of anesthesia: a decision-making approach. Anesth Analg. 2006 Jan;102(1):81-4. doi: 10.1213/01.ANE.0000181100.27931.A1. — View Citation
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012. — 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. doi: 10.1001/archpedi.1996.02170370016002. — View Citation
Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013. — View Citation
Kim JE, Jo BY, Oh HM, Choi HS, Lee Y. High anxiety, young age and long waits increase the need for preoperative sedatives in children. J Int Med Res. 2012;40(4):1381-9. doi: 10.1177/147323001204000416. — View Citation
Kuhlmann AYR, Lahdo N, Staals LM, van Dijk M. What are the validity and reliability of the modified Yale Preoperative Anxiety Scale-Short Form in children less than 2 years old? Paediatr Anaesth. 2019 Feb;29(2):137-143. doi: 10.1111/pan.13536. Epub 2018 Dec 23. — View Citation
Pearce JI, Brousseau DC, Yan K, Hainsworth KR, Hoffmann RG, Drendel AL. Behavioral Changes in Children After Emergency Department Procedural Sedation. Acad Emerg Med. 2018 Mar;25(3):267-274. doi: 10.1111/acem.13332. Epub 2017 Nov 13. — View Citation
Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Apr;117(4):1162-8. doi: 10.1542/peds.2005-1100. — View Citation
Thung A, Tumin D, Uffman JC, Tobias JD, Buskirk T, Garrett W, Karczewski A, Saadat H. The Utility of the Modified Yale Preoperative Anxiety Scale for Predicting Success in Pediatric Patients Undergoing MRI Without the Use of Anesthesia. J Am Coll Radiol. 2018 Sep;15(9):1232-1237. doi: 10.1016/j.jacr.2017.12.022. Epub 2018 Mar 2. — View Citation
Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. doi: 10.1207/s15324796abm3003_11. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-Hospitalization Behavior Questionnaire (PHBQ) | Post-Hospitalization Behavior Questionnaire, a parent-report tool, with 27 items in six categories, comprising general, separation, and sleep anxieties, eating disturbance, aggression towards authority, apathy/withdrawal accesses negative behavioral changes in children post-surgery, hospitalization (Kain et al., 1996, Kain et al., 1999) or after minor ED procedures (Brodzinski et al., 2013). It takes 10 minutes and is given prior to the sedation and at 1-week via text/email, phone, or mail follow up post-discharge.
Parents compare their child's behavior pre-hospitalization to post using the following: much less than before (1), less than before (2), same as before (3), more than before (4), and much more than before (5). Scores above 3 indicate greater maladaptive behavioral changes, below 3 indicate improvements and 3 indicates no change in behavior. |
24 months | |
Secondary | Modified Yale Preoperative Anxiety Scale (m-YPAS) | The m-YPAS assesses study participant's anxiety at the time of induction of anesthesia. It is completed in <1 minute, reliable, and its validity compares favorably to the State Trait Anxiety Inventory for Children (Kain, Z. 1997). The Emergency Department provider completes the m-YPAS twice during the study: on patient arrival/enrollment and immediately preceding sedation after VR intervention or standard of care.
m-YPAS categories are activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent). Each item has Likert-type responses reflecting children behaviors and is rated from 1 to 4 or 1 to 6 (depending on the item), and higher numbers indicate the highest severity within that item. Scores range from 23-100 and a score >30 is defined as anxious. |
24 months |
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