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Intervention group ( video) for Anxiety

N/A

Recruiting

Led By Michael Bezuhly, MD

Research Sponsored by IWK Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will test if watching an informative video the day before surgery can help reduce anxiety in children undergoing otoplasty. Children and their families will either watch the video or not, and anxiety levels

Who is the study for?

This trial is for children aged 4-12 who understand English, have not had otoplasty before, and are scheduled for ear pinning surgery without other procedures on the same day. Their parent must read English at a grade six level.Check my eligibility

What is being tested?

The study tests if watching an animated video about surgery can reduce anxiety in kids before they get anesthesia for ear pinning. Kids will be randomly chosen to either watch the video or not, and their anxiety levels will be compared.See study design

What are the potential side effects?

Since this trial involves an educational animated video, there are no direct medical side effects expected from participating in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mypas score while in the preoperative waiting area

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mypas score while in the preoperative waiting area

This trial's timeline: 3 weeks for screening, Varies for treatment, and mypas score while in the preoperative waiting area for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

modified Yale Preoperative Anxiety Scale (mYPAS)

parental self-reported anxiety using the State-Trait Anxiety Inventory

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention group ( video)Experimental Treatment1 Intervention

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

Group II: Control group (no video)Active Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IWK Health CentreLead Sponsor

125 Previous Clinical Trials

100,433 Total Patients Enrolled

2 Trials studying Anxiety

225 Patients Enrolled for Anxiety

Michael Bezuhly, MDPrincipal InvestigatorIWK Health Centre

1 Previous Clinical Trials

240 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 45 eligible for enrollment in this research study?

"Potential participants must be between 4 and 12 years old to meet the age requirements for inclusion in this clinical trial."

Answered by AI

What is the current number of individuals actively involved in this medical study?

"Indeed, data accessible on clinicaltrials.gov indicates an ongoing search for suitable candidates to join this medical trial. The initial posting of the trial was recorded on June 1st, 2023, with the most recent update made on March 4th, 2024. The study aims to enlist a total of 40 participants from one designated site."

Answered by AI

Do I meet the necessary criteria to participate in this clinical investigation?

"To qualify for participation in this research study, patients must be within the age range of 4 to 12 years and exhibit symptoms indicative of anxiety. The trial is seeking a total of 40 eligible participants."

Answered by AI

Are potential participants currently able to apply for this ongoing medical study?

"Indeed, data on clinicaltrials.gov reveals that this investigation is actively seeking eligible participants. The trial was first uploaded on June 1st, 2023 and underwent its latest update on March 4th, 2024. Researchers aim to recruit a total of 40 subjects from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Michael Bezuhly 2023. "The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05894187.