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

March 4, 2024 updated by: Michael Bezuhly, IWK Health Centre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group (no video)
Children in this group will not receive a link to view an informational animated prior to their surgery date
Experimental: Intervention group ( video)
Children in this group will receive a link to view an informational animated video 3 nights prior to their surgery date.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
modified Yale Preoperative Anxiety Scale (mYPAS)
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame: 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
mYPAS score while in the preoperative waiting area
parental self-reported anxiety using the State-Trait Anxiety Inventory
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IWK Health Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Bezuhly, MD, IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1028283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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