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

Not Applicable

Recruiting

• Conditions: Pre-operative Anxiety; Otoplasty; Paediatric Surgery
• Interventions: Other: animated video

• Registration Number: NCT05894187
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-21
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
modified Yale Preoperative Anxiety Scale (mYPAS)	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.	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

Name	Time	Method
parental self-reported anxiety using the State-Trait Anxiety Inventory	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	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)	mYPAS score while in the preoperative waiting area	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

Trial Locations

Locations (1)

IWK health centre; 🇨🇦 Halifax, Nova Scotia, Canada