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The Magic Coat Trial: Investigating the effect of activating coping skills and resilience on perioperative anxiety levels in children in the hospital and beyond

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000403639
Enrollment
400
Registered
2023-04-19
Start date
2023-07-20
Completion date
2024-08-29
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 Hospi

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.

Sponsors

Perth Children's Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
4 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

Children admitted to the 'day of surgery' unit undergoing elective surgery at Perth Children’s Hospital.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026