Clinical trial NCT06990555: Cast Art for Kids With Extremity Fractures
Official title: Cast Art for Kids With Extremity Fractures on Satisfaction and Perception of Pain (CAKEPOP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Bone
Keywords: Cast
Art
Fractures
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2025-05-25
Enrollment: 96
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Visual Analog Scale for Satisfaction
timeFrame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)
Secondary outcomes:
measure: PedsQL Pediatric Pain Questionnaire
timeFrame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
References: