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Trial registered on ANZCTR


Registration number
ACTRN12623000403639
Ethics application status
Approved
Date submitted
15/03/2023
Date registered
19/04/2023
Date last updated
4/08/2023
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Magic Coat Trial: Investigating the effect of activating coping skills and resilience on perioperative anxiety levels in children in the hospital and beyond
Scientific title
Investigating the effect of a novel evidence-based interactive Magic Coat (Cognitive Behavioural) program on perioperative anxiety levels and resilience in children in Perth Children's Hospital and beyond (Magic Coat)
Secondary ID [1] 309085 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative anxiety 329149 0
Children undergoing general anaesthesia 329361 0
Condition category
Condition code
Anaesthesiology 326128 326128 0 0
Other anaesthesiology
Mental Health 326530 326530 0 0
Anxiety
Surgery 326531 326531 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Magic Coat program aims to introduce skills to children based on cognitive behavioural techniques using easily relatable characters in a story. The characters embody evidence-based strategies and are designed to help manage anxiety, build resilience and reduce the trauma associated with medical procedures.

This project is a collaboration with the Magic Coat Foundation and Perth Children's Hospital to develop a novel, interactive Magic Coat online storybook specific to Perth Children's Hospital's perioperative needs. The online storybook application will contain short videos filmed at Perth Children's Hospital documenting the perioperative journey to enhance familiarisation, as well as the Magic Coat characters.

The Magic Coat is a coat that symbolises the power of positive thought and utilises a child’s natural tendency to leverage imagination, encouraging the child to explore the coat pockets, where they find each contains a character with a seaside theme. Each characterises a different techniques or skills, for example;
a. Rewards for trying new things
b. Developing problem-solving skills
c. Reframing and managing self-talk
d. Positive affirmation
e. Distraction, breathing techniques.

The online resource has several features designed to improve access for even the most vulnerable children:
a. Free of charge and accessible on a range of devices including smartphones
b. Customisable to age and cultural background with a version specific for Indigenous families
c. Characters specifically designed to be relevant to children with special needs
d. Audio-enabled to help overcome literacy challenges.

This single centre sequential pre and post implementation prospective cohort clinical trial to assess the effectiveness of the (Perth Children's Hospital specific) Magic Coat program in the perioperative period. It will take place in 3 distinct phases.

Phase 1 - Control group
Phase 2 - Training
A three-month staff introduction and training phase will occur after control group recruitment has concluded.
Staff training will be performed by clinical staff of the Department of Anaesthesia and Pain Medicine as well as from research team members from the Magic Coat Foundation. This will be overseen by the Head of Department of Anaesthesia and Pain Medicine. The training will be conducted face to face in groups of staff. Staff members will receive multiple training sessions and senior staff members will ensure all members of their teams are adequately trained.
The novel Magic Coat resource will be introduced into the perioperative environment during phase 2 from booking in patients through to postoperative care areas and all perioperative staff will be trained on the premise and use of the Magic Coat program. The standard clinical information letter sent to families before surgery will include a link to the Magic Coat online application resource for them to access at their discretion. A prompt to use the resource will be included with the standard clinical preoperative telephone call, and the program will be reinforced by perioperative staff and through addressing it in clinical consults, pictures, posters, pillowslips and colouring in sheets in the hospital. Following Phase 2, the Magic Coat Perioperative Program will be implemented as standard clinical practice for all children presenting to Perth Children's Hospital for surgery.

Phase 3 - Implementation
Following the staff training and introduction of the Magic Coat Program into routine care, we will recruit families into the post implementation (Magic Coat) group. We will recruit 200 families booked for elective surgery who will have received the link to the interactive online resource as per the new clinical standard when they are sent booking information will be recruited. A prompt to use the app will be included with the preoperative telephone call. It is expected that it will take less than 1 hour for the family to review the content of the application. Additional outcome data will be collected for the post implementation group families (see below). The Magic Coat principles will be reinforced in all patients (research participants and non-research participants) by perioperative staff who have been trained using the common language and aided with the help of pictures, posters, pillowslips and colouring in sheets.
The children will again be assessed for anxiety and behaviour using the validated m-YPAS scale, along with demographic, anaesthetic and surgical information. The families will also collect information on whether the participants have accessed support programs such as Keeping Kids in No Distress (KKIND), Starlight or other emotional support/therapy animals for this admission. It is anticipated this phase will take up to 6 months. We aim to compare this cohort with the pre-implementation cohort to evaluate the effectiveness of the new resource. We are going to collect the following additional information on the families use of the Magic Coat application: time spent on app, specific pages viewed, most frequently loaded pages and which demographic uses what pages.

Intervention code [1] 325529 0
Prevention
Intervention code [2] 325530 0
Behaviour
Intervention code [3] 325531 0
Treatment: Other
Comparator / control treatment

Phase 1 - Control group
Control, baseline data will be collected with the recruitment of 200 families over an initial period to assess current clinical practice and standard of care, and measure anxiety and behaviour. Anxiety will be measured using a validated scale the modified Yale Preoperative Anxiety Scale (mYPAS), along with other demographic, anaesthetic and surgical information. Information on whether the participants have accessed anxiety and coping support programs in the hospital or other emotional support/therapy animals for this admission will also be recorded.
The control group will include 200 participants.
Control group
Active

Outcomes
Primary outcome [1] 333994 0
The primary outcome is to compare change in levels of anxiety from baseline (T1) to anaesthetic induction (T3) between the Phase 1 control group and Phase 3 Magic Coat group. This will be assessed using the modified Yale Preoperative Anxiety Scale (mYPAS).
Timepoint [1] 333994 0
The mYPAS for each participant will be documented upon preoperative admission (T1), during sign-in to theatre (T2) and at anaesthetic induction (T3).
Secondary outcome [1] 418983 0
Compare induction compliance, using the Induction Compliance Checklist (ICC), between the Phase 1 control group and Phase 3 Magic Coat group.
Timepoint [1] 418983 0
Anaesthetic induction timepoint.
Secondary outcome [2] 418984 0
Compare postoperative analgesia requirements between the Phase 1 control group and Phase 3 Magic Coat group by examining the medical records and recording the data on study specific case report forms.
Timepoint [2] 418984 0
Until hospital discharge or the 24 hours after the end of surgery.
Secondary outcome [3] 418985 0
Compare incidence of emergence delirium using the Cornell Assessment of Paediatric Delirium (CAP-D) between the Phase 1 control group and Phase 3 Magic Coat group.
Timepoint [3] 418985 0
During recovery in the Post-Anaesthetic Care Unit (PACU). This will be assessed in PACU by the patient’s nurse when patient is First Awake and then +5mins, +10mins, +20 mins, +40mins, +60mins (as relevant) until PACU discharge time.
Secondary outcome [4] 418986 0
Compare post-operative behavioural outcomes using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) between the Phase 1 control group and Phase 3 Magic Coat group.
Timepoint [4] 418986 0
One day after surgery, again at one week after surgery and again at one month after surgery.

Eligibility
Key inclusion criteria
Children admitted to the 'day of surgery' unit undergoing elective surgery at Perth Children’s
Hospital.
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children undergoing emergency surgery.
2. Children coming for surgery via a ward other than the 'day of surgery' unit.
3. Any concern in the ability of the parents/guardian or child to appropriately adhere to the study protocol or any issues which, in the investigator’s opinion, would increase the risks of study participation to the child.
4. Language barriers impeding data collection.
5. Department for Child Protection and Family Support is involved in the care of the child.
6. Inability for the child to interact with the resource/program, such as children with severe global developmental delay, visual or auditory impairments.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential cohort trial - control group recruitment, then post intervention implementation and staff training, intervention group recruitment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis will be conducted in the R statistical environment. Statistical significance will be taken at 5% (0.05). Numerical and graphical data exploration will be conducted to assess the behaviour of the data.

For the primary hypothesis, a linear statistical model will be fitted to the data with the difference between anxiety scores at anaesthetic induction (T3), sign-in to theatre (T2) and at preoperative (T1) as the response. The anxiety score at T1 will be a moderator. The rationale is that the difference in scores may depend on the level of the score at T1. The demographics and procedural variables will be included as covariates in the model, along with the cohort.

The effect of The Magic Coat Perioperative Program compared to the control will be assessed on the anxiety scores after adjusting for demographic and other variables. Other exploratory analysis will be considered, such as principal components and linear discriminant analysis. Since this is the first of this type of study, no prior data is available for sample size calculations, however, we will perform a post power analysis once the data is collected. We expect the sample size of 200 in each group is more than adequate for high power.

For the secondary hypotheses, linear statistical models will be fitted against the available covariates as appropriate. The score for the treatment group should be at lower by at least 10 on mYPAS scale, adjusted for the covariates, for the result to be deemed clinically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/07/2023
Actual
20/07/2023
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
20/01/2025
Actual
Sample size
Target
400
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24133 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 39645 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 313288 0
Hospital
Name [1] 313288 0
Perth Children's Hospital
Country [1] 313288 0
Australia
Funding source category [2] 313290 0
Government body
Name [2] 313290 0
NHMRC
Country [2] 313290 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 315028 0
None
Name [1] 315028 0
Address [1] 315028 0
Country [1] 315028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312518 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 312518 0
Child and Adolescent Health Service Human Research Ethics Committee
15 Hospital Avenue
Nedlands
Western Australia 6009
Ethics committee country [1] 312518 0
Australia
Date submitted for ethics approval [1] 312518 0
16/01/2023
Approval date [1] 312518 0
08/03/2023
Ethics approval number [1] 312518 0
RGS0000005924

Summary
Brief summary
Anxiety associated with medical procedures is common with 40-80% of children experiencing perioperative anxiety. Children can experience significant symptoms and postoperative consequences due to perioperative anxiety, including distress and delirium, increased intensity and duration of pain, prolonged hospital stay, behavioural and sleep disturbance and avoidance of medical encounters which often remain into adulthood.

The Magic Coat Perioperative Program will be a novel, evidence-based interactive program delivered in an online format and reinforced throughout the hospital journey that aims to promote coping skills and resilience in children.

This sequential pre and post intervention prospective cohort clinical trial will examine the impact of an accessible, customisable online resource designed to introduce and build upon skills for communicating and managing anxiety among children in the peri-operative period and improving induction compliance.

Primary hypothesis;
Children introduced to the Magic Coat Program via the online storybook who have those skills developed and reinforced during their hospital stay will display a significantly smaller increase in anxiety during anaesthetic induction from baseline (Timepoint 1(T1)), compared with conventional techniques for reducing peri-operative anxiety.

Secondary hypotheses;
Children introduced to the Magic Coat Program via the online storybook who have those skills developed and reinforced during their hospital stay will, compared with conventional methods of managing perioperative anxiety,
1. Display better induction compliance
2. Be less likely to receive a sedative pre-medication
3. Require less postoperative analgesia for comparable interventions (in the 24 hours following surgery)
4. Be less likely to experience postoperative delirium
5. Experience improved parental and child satisfaction with the perioperative experience
6. Less negative behavioural outcomes at 1weeks and 1-month post procedure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124946 0
Prof Britta Regli-von Ungern-Sternberg
Address 124946 0
Perth Children's Hospital
Department of Anesthesia and Pain Medicine
15 Hospital Avenue
Nedlands
WA 6009
Country 124946 0
Australia
Phone 124946 0
+61 8 6456 4805
Fax 124946 0
Email 124946 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for public queries
Name 124947 0
Prof Britta Regli-von Ungern-Sternberg
Address 124947 0
Perth Children's Hospital
Department of Anesthesia and Pain Medicine
15 Hospital Avenue
Nedlands
WA 6009
Country 124947 0
Australia
Phone 124947 0
+61 8 6456 4805
Fax 124947 0
Email 124947 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 124948 0
Prof Britta Regli-von Ungern-Sternberg
Address 124948 0
Perth Children's Hospital
Department of Anesthesia and Pain Medicine
15 Hospital Avenue
Nedlands
WA 6009
Country 124948 0
Australia
Phone 124948 0
+61 8 6456 4805
Fax 124948 0
Email 124948 0
Britta.Regli-VonUngern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Investigators for the study have not yet decided on data sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.