The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty
NCT ID: NCT05894187
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-06-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Control group (no video)
Children in this group will not receive a link to view an informational animated prior to their surgery date
No interventions assigned to this group
Intervention group ( video)
Children in this group will receive a link to view an informational animated video 3 nights prior to their surgery date.
animated video
Participants randomized to the intervention group will receive a link to a short survey gauging parent anxiety levels three days prior to their childs surgery date. If randomly assigned to watch the informative animated video, the survey will be followed by a link to a video which families are free to watch prior to your child's surgery date. Once participants and there family watch the video, they will be asked to rate the quality of the video on a scale of 0 (very bad) to 10 (excellent). Responses to this question will be used to confirm that participants watched the video to the end.
Interventions
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animated video
Participants randomized to the intervention group will receive a link to a short survey gauging parent anxiety levels three days prior to their childs surgery date. If randomly assigned to watch the informative animated video, the survey will be followed by a link to a video which families are free to watch prior to your child's surgery date. Once participants and there family watch the video, they will be asked to rate the quality of the video on a scale of 0 (very bad) to 10 (excellent). Responses to this question will be used to confirm that participants watched the video to the end.
Eligibility Criteria
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Inclusion Criteria
* The patient must not have previously undergone an otoplasty; the patient must be between the ages of 4 and 12;
* The patient must understand spoken English;
* The participating parent must be able to read English at a grade six level; and the patient should not have received premedication.
Exclusion Criteria
* Have not undergone a previous otoplasty
4 Years
12 Years
ALL
Yes
Sponsors
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IWK Health Centre
OTHER
Responsible Party
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Michael Bezuhly
Head, Division of Plastic & Reconstructive Surgery Director, Craniofacial Program IWK Health Centre
Principal Investigators
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Michael Bezuhly, MD
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Locations
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IWK health centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Spielberger CD. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983.
Heeren A, Bernstein EE, McNally RJ. Deconstructing trait anxiety: a network perspective. Anxiety Stress Coping. 2018 May;31(3):262-276. doi: 10.1080/10615806.2018.1439263. Epub 2018 Feb 13.
Marechal C, Berthiller J, Tosetti S, Cogniat B, Desombres H, Bouvet L, Kassai B, Chassard D, de Queiroz Siqueira M. Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction. Br J Anaesth. 2017 Feb;118(2):247-253. doi: 10.1093/bja/aew436.
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.
Neville DN, Hayes KR, Ivan Y, McDowell ER, Pitetti RD. Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department. Acad Emerg Med. 2016 Aug;23(8):910-7. doi: 10.1111/acem.12998.
Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.
Other Identifiers
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1028283
Identifier Type: -
Identifier Source: org_study_id
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