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The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty

Primary Purpose

Pre-operative Anxiety, Otoplasty, Paediatric Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
animated video
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pre-operative Anxiety focused on measuring otoplasty, pre-operative anxiety, animated video

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group (no video)

    Intervention group ( video)

    Arm Description

    Children in this group will not receive a link to view an informational animated prior to their surgery date

    Children in this group will receive a link to view an informational animated video 3 nights prior to their surgery date.

    Outcomes

    Primary Outcome Measures

    modified Yale Preoperative Anxiety Scale (mYPAS)
    The mYPAS is a validated observational measure to assess the behaviour of children of all ages preoperatively and consists of 27 items divided into five domains (activity, emotional status, arousal state, vocalization, and use of parents).24,27,28 The mYPAS scores range from 22 to 100, with higher values indicating greater anxiety. The mYPAS is considered the gold-standard for observational preoperative anxiety assessment in paediatric patients.24,27-30

    Secondary Outcome Measures

    parental self-reported anxiety using the State-Trait Anxiety Inventory
    The STAI, which consists of two 20-item subscales measures is self-administered on a four-point scale for each item. The scores for each of the subscales range from a minimum of 20 to a maximum of 80, the higher scores suggest the greater psychological anxiety. The tool was designed to differentiate between the temporary condition of "state anxiety" in response to an acute event and the more general and long-standing quality of "trait anxiety" entrenched in the individual's personality. This tool has been validated in a variety of clinical settings including parental anxiety prior to a child's surgery.26
    modified Yale Preoperative Anxiety Scale (mYPAS)
    The mYPAS is a validated observational measure to assess the behaviour of children of all ages preoperatively and consists of 27 items divided into five domains (activity, emotional status, arousal state, vocalization, and use of parents).24,27,28 The mYPAS scores range from 22 to 100, with higher values indicating greater anxiety. The mYPAS is considered the gold-standard for observational preoperative anxiety assessment in paediatric patients.24,27-30

    Full Information

    First Posted
    May 21, 2023
    Last Updated
    June 7, 2023
    Sponsor
    IWK Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05894187
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IWK Health Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-operative Anxiety, Otoplasty, Paediatric Surgery
    Keywords
    otoplasty, pre-operative anxiety, animated video

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    prospective, randomized, single-blind controlled superiority
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group (no video)
    Arm Type
    No Intervention
    Arm Description
    Children in this group will not receive a link to view an informational animated prior to their surgery date
    Arm Title
    Intervention group ( video)
    Arm Type
    Experimental
    Arm Description
    Children in this group will receive a link to view an informational animated video 3 nights prior to their surgery date.
    Intervention Type
    Other
    Intervention Name(s)
    animated video
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    modified Yale Preoperative Anxiety Scale (mYPAS)
    Description
    The mYPAS is a validated observational measure to assess the behaviour of children of all ages preoperatively and consists of 27 items divided into five domains (activity, emotional status, arousal state, vocalization, and use of parents).24,27,28 The mYPAS scores range from 22 to 100, with higher values indicating greater anxiety. The mYPAS is considered the gold-standard for observational preoperative anxiety assessment in paediatric patients.24,27-30
    Time Frame
    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 Outcome Measure Information:
    Title
    parental self-reported anxiety using the State-Trait Anxiety Inventory
    Description
    The STAI, which consists of two 20-item subscales measures is self-administered on a four-point scale for each item. The scores for each of the subscales range from a minimum of 20 to a maximum of 80, the higher scores suggest the greater psychological anxiety. The tool was designed to differentiate between the temporary condition of "state anxiety" in response to an acute event and the more general and long-standing quality of "trait anxiety" entrenched in the individual's personality. This tool has been validated in a variety of clinical settings including parental anxiety prior to a child's surgery.26
    Time Frame
    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
    Title
    modified Yale Preoperative Anxiety Scale (mYPAS)
    Description
    The mYPAS is a validated observational measure to assess the behaviour of children of all ages preoperatively and consists of 27 items divided into five domains (activity, emotional status, arousal state, vocalization, and use of parents).24,27,28 The mYPAS scores range from 22 to 100, with higher values indicating greater anxiety. The mYPAS is considered the gold-standard for observational preoperative anxiety assessment in paediatric patients.24,27-30
    Time Frame
    mYPAS score while in the preoperative waiting area

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Bezuhly, MD
    Phone
    902 470 8168
    Email
    michael.bezuhly@iwk.nshealt.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Bezuhly, MD
    Organizational Affiliation
    IWK Health Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9322455
    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.
    Results Reference
    background
    Citation
    Spielberger CD. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983.
    Results Reference
    background
    PubMed Identifier
    29433339
    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.
    Results Reference
    background
    PubMed Identifier
    28100529
    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.
    Results Reference
    background
    PubMed Identifier
    30365208
    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.
    Results Reference
    background
    PubMed Identifier
    27129606
    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.
    Results Reference
    background
    PubMed Identifier
    23051880
    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.
    Results Reference
    background

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    The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty

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