Cast Art for Broken Bones
(CAKE POP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different types of casts affect satisfaction and pain perception in children with broken arms or legs. Participants will be randomly assigned to one of three groups: a plain white cast, a colored cast of their choice, or a cast with custom art, such as drawings or glitter (referred to as "Cast Art"). Researchers aim to determine if adding color or art to a cast increases happiness and reduces pain perception in children. The trial seeks children aged 5 to 17 who have recently broken a limb and have an upcoming orthopedic appointment. As an unphased trial, this study offers a unique opportunity for children to contribute to research that could make wearing a cast a more positive experience.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications, so it's best to ask the study team for guidance.
What prior data suggests that cast art is safe for children with fractures?
Research shows that casts, whether plain or decorated with art, are generally safe for people with broken bones. A study involving 120 patients with broken limbs found that traditional plaster casts were well-tolerated, with no major issues or complications. Some studies have noted minor skin irritation with certain materials, but these were not specifically linked to the art on the casts.
This trial does not test a new drug or medical device, so the risks remain low. The main focus is on the appearance of the casts—whether they're plain, colored, or have custom art. Thus, the safety level aligns with what is already known for standard casts.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they add a creative and personalized twist to the traditional cast for broken bones. Unlike the standard neutral white casts, participants can choose a cast with color, allowing them to express their individuality. Additionally, the option for Cast Art is truly unique, offering the possibility of adding drawings, multiple colors, glitter, and other artwork to the cast, making the healing process more enjoyable and engaging. These options aim to improve the patient's experience by turning a typically dull and clinical necessity into a canvas for personal expression.
What evidence suggests that cast art could be effective for improving satisfaction and reducing perceived pain in children with broken bones?
This trial will compare different cast options, including a Color Wrapped Cast, a Neutral White Cast, and a Cast with Cast Art. Studies have shown that adding art to casts can make them more enjoyable and less boring for children. Research suggests that casts with custom designs might increase satisfaction and comfort for kids. A review of casting methods found that colorful and special casts could help reduce pain and improve movement for some conditions. Although specific data on cast art is limited, the idea is that making the cast experience more fun could improve children's feelings about wearing one. Initial findings suggest that children might experience less discomfort when they can choose the appearance of their cast.26789
Are You a Good Fit for This Trial?
This trial is for children who have suffered from a hip fracture or other broken bones and need to wear a cast. The study will include those eligible for random assignment to one of three types of casts: plain white, colored wrap, or custom art.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a cast with or without customization based on randomization
Follow-up
Participants are monitored for satisfaction and pain perception using VAS and PedsQL questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Cast Art
Find a Clinic Near You
Who Is Running the Clinical Trial?
United States Naval Medical Center, Portsmouth
Lead Sponsor