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

NCT05894187 | Recruiting

• 1 other identifier: 1028283
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-operative Anxiety; Otoplasty; Paediatric Surgery

Keywords

otoplasty; pre-operative anxiety; animated video

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• modified Yale Preoperative Anxiety Scale (mYPAS)

  mYPAS score while in the preoperative waiting area

Study Arms (2)

Control group (no video)

NO INTERVENTION

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

Intervention group ( video)

EXPERIMENTAL

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

Other: animated video

Interventions

animated video OTHER

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.

Intervention group ( video)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Under the age of 4 or over the age of 12
• Have not undergone a previous otoplasty

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK health centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 9322455 BACKGROUND

• Spielberger CD. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983.

  BACKGROUND

• 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.

  PMID: 29433339 BACKGROUND

• 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.

  PMID: 28100529 BACKGROUND

• 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.

  PMID: 30365208 BACKGROUND

• 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.

  PMID: 27129606 BACKGROUND

• 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.

  PMID: 23051880 BACKGROUND

Study Officials

• Michael Bezuhly, MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bezuhly, MD

CONTACT

902 470 8168; michael.bezuhly@iwk.nshealt.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Plastic & Reconstructive Surgery Director, Craniofacial Program IWK Health Centre

Model Details: prospective, randomized, single-blind controlled superiority

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)