Pre-operative AnxietyNCT05894187
The Impact of an Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty
A study testing animated video in people with Pre-operative Anxiety and Otoplasty, run by IWK Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-operative Anxiety, Otoplasty, Paediatric Surgery
- What is being tested?
- animated video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Under the age of 4 or over the age of 12
- Have not undergone a previous otoplasty
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK health centre
Halifax, Nova Scotia, B3K 6R8
Michael Bezuhly, MD, (902) 470-8168, Michael.Bezuhly@iwk.nshealth.ca
About this study
Official title: 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.
- Conditions
- Pre-operative Anxiety, Otoplasty, Paediatric Surgery
- Being tested
- animated video
- Keywords
- otoplasty, pre-operative anxiety, animated video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animated videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: animated video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: mYPAS score while in the preoperative waiting area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pre-operative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- prospective, randomized, single-blind controlled superiority
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bezuhly, IWK Health Centre
- Investigators
- Michael Bezuhly, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894187
- Sponsor's protocol ID
- 1028283
- Status last verified
- Mar 2024
- First submitted
- 21 May 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9322455Spielberger CD. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983.
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.
PubMed 29433339Marechal 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.
PubMed 28100529Kuhlmann 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.
PubMed 30365208Neville 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.
PubMed 27129606Mifflin 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.
PubMed 23051880
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of an Informative Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty and Their Parents
- ClinicalTrials.gov ID
- NCT05894187
- Acronym / sponsor ID
- 1028283
- Conditions
- Pre-operative Anxiety, Otoplasty, Paediatric Surgery
- Keywords
- otoplasty, pre-operative anxiety, animated video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, single-blind controlled superiority
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: animated videoChildren in this group will receive a link to view an informational animated video 3 nights prior to their surgery date. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Under the age of 4 or over the age of 12
- Have not undergone a previous otoplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| animated videoParticipants 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. | Other | Intervention group ( video) |
Primary outcome
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
2 secondary outcomes
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
modified Yale Preoperative Anxiety Scale (mYPAS)
Time frame: mYPAS score while in the preoperative waiting area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 9322455Kain 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.
- BackgroundSpielberger CD. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press, 1983.
- Background: PubMed 29433339Heeren 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.
- Background: PubMed 28100529Marechal 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.
- Background: PubMed 30365208Kuhlmann 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.
- Background: PubMed 27129606Neville 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.
- Background: PubMed 23051880Mifflin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bezuhly, MD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing animated video in people with Pre-operative Anxiety and Otoplasty, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Bezuhly, MD (902 470 8168, michael.bezuhly@iwk.nshealt.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894187, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.