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

Study Overview
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Brief Summary
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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.

Official Title
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Exploring the Effects of an Informative Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty and Their Parents

Conditions
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Pre-operative Anxiety, Otoplasty, Paediatric Surgery

Intervention / Treatment
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* Other: animated video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, randomized, single-blind controlled superiority
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (no video)<br>Children in this group will not receive a link to view an informational animated prior to their surgery date | |
| Experimental: Intervention group ( video)<br>Children in this group will receive a link to view an informational animated video 3 nights prior to their surgery date. | Other: animated video<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | mYPAS score while in the preoperative waiting area | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otoplasty, pre-operative anxiety, animated video