Cast Art for Kids With Extremity Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neutral White Cast, Color Wrapped Cast, Cast with Cast Art.
- Who it may be relevant to
- Registry conditions: Fractures, Bone. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cast Art for Kids With Extremity Fractures on Satisfaction and Perception of Pain (CAKEPOP)
Overview
The goal of this clinical trial is to compare casts with cast art versus those without art in children who sustain a fracture of the extremity. The main goals are: * Determine the difference in satisfaction as measured by the visual analog scale for satisfaction between patients treated in a cast with cast customization versus those in a cast with no cast art * Determine the difference in perceived pain scores between patients treated in a cast with cast customization versus those in a case with no cast art Participants will be randomized to one of three groups: one with plain white cast, one with cast of color wrap of choice, and one with custom cast art. Researchers will compare to see the differences in satisfaction and perception of pain based on what cast the study participant receives.
Detailed description
Upper and lower extremity fractures are common amongst the pediatric population, with nearly 1 in every 5 children sustaining a fracture throughout their childhood and adolescence. Immobilization following an upper or lower extremity fracture is essential for treatment and bony healing, and this is most commonly performed with casting. Casts are placed in the acute setting in the emergency department or at an outpatient follow up visit; however, if the patient requires surgery, casts are also placed in the post operative period to aid in bony healing through immobilization. Length of treatment in the cast is dependent on the type of fracture the patient sustains, in addition to the bony healing that is analyzed via serial radiographs.
Given the prevalence of upper and lower extremity fractures among the pediatric population, overall patient and parent satisfaction is a key goal of treatment. While casting is extensively used at numerous pediatric orthopaedic centers, there is a paucity of information detailing patient reported outcome measures following casting. Typically casts are left to be either white in color or wrapped with a color of the patient's choice. Further customization of casts is now being popularized especially in social media, including drawing on the casts or applying decorative top-coat layers to the cast. However, there is little information detailing patient satisfaction and pain scores following casting with different techniques.
The purpose of this study is to: determine the difference in satisfaction as measured by the visual analog scale for satisfaction between patients treated in a cast with cast customization versus those in a cast with no cast art and (2) determine the difference in perceived pain scores between patients treated in a cast with cast customization versus those in a case with no cast art.
Interventions
- Other Neutral White Cast
This intervention consists of receiving a cast of neutral white color. - Other Color Wrapped Cast
This intervention consists of receiving a cast of color that is the choice of the participant. - Other Cast with Cast Art
This intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork.
Primary outcome measures
- Visual Analog Scale for Satisfaction [Time frame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)]
Secondary outcome measures (1)
- PedsQL Pediatric Pain Questionnaire [Time frame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)]
Eligibility criteria
Inclusion criteria
- Age 5 years old and greater, and less than 18 years old
- Sustained an upper or lower extremity fracture
- Scheduled for orthopedic clinic visit for injury evaluation
- Have radiographic and clinical data available for review
Exclusion criteria
- Age 18 years old or greater at the time of screening
- Patient/parents do not consent to being included in the study
- Underwent surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Naval Medical Center Portsmouth — Portsmouth
Identifiers
NCT: NCT06990555 · 939056