Clinical trial NCT05894187: The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty
Official title: Exploring the Effects of an Informative Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty and Their Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-operative Anxiety
Otoplasty
Paediatric Surgery
Keywords: otoplasty
pre-operative anxiety
animated video
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: prospective, randomized, single-blind controlled superiority
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is a prospective, randomized, single-blind controlled superiority trial to evaluate the effect of viewing an informative animated video a day prior to surgery on preoperative anxiety in pediatric patients scheduled for elective otoplasty. The primary outcome will be modified Yale Preoperative Anxiety Scale (mYPAS) score at the time of general anesthesia induction compared between families that were assigned to view the animated video the day before and those that were not. The participants for this study will be children undergoing elective otoplasty at the IWK Health Centre. Those participants randomized to the intervention group will receive a link to a short survey gauging parent anxiety levels. The survey will be followed by a link to an informative animated video which the participants and their families will watch. The control group will be participants assigned not to receive the email link to the informative animated video.


Eligibility criteria: Inclusion Criteria:

* They are undergoing an otoplasty alone with no other procedures on the same day
* 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:

* Under the age of 4 or over the age of 12
* Have not undergone a previous otoplasty

Primary outcomes:
measure: modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: Data acquisition will occur within 24 hours. Recording will start once patient enters room and is positioned on OR table. Recording will stop one minute after induction mask is put on patient. Total recording time will be five minutes.
Secondary outcomes:
measure: parental self-reported anxiety using the State-Trait Anxiety Inventory
timeFrame: Within 48 hours prior to arrival at the IWK for surgery and again upon arrival at the IWK immediately prior to their child leaving the waiting area to enter the operating room
measure: modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: mYPAS score while in the preoperative waiting area
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK health centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Michael Bezuhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Spielberger CD. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.