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Cast Art for Kids With Extremity Fractures

Cast Art for Kids With Extremity Fractures on Satisfaction and Perception of Pain (CAKEPOP)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06990555
Acronym
CAKE POP
Enrollment
96
Registered
2025-05-25
Start date
2023-05-08
Completion date
2025-12-30
Last updated
2025-10-09

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

Conditions

Fractures, Bone

Keywords

Cast, Art, Fractures

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.

Interventions

OTHERNeutral White Cast

This intervention consists of receiving a cast of neutral white color.

OTHERColor Wrapped Cast

This intervention consists of receiving a cast of color that is the choice of the participant.

OTHERCast 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.

Sponsors

United States Naval Medical Center, Portsmouth
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale for Satisfaction0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)VAS for satisfaction will be obtained of the patient and parent. The scale range is from no satisfaction (Lowest) to extreme satisfaction (highest). The parent and child place a mark on the line the best describes their satisfaction level.

Secondary

MeasureTime frameDescription
PedsQL Pediatric Pain Questionnaire0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)PedsQL Pediatric Pain Questionnaire will be obtained of the patient and parent. The scale range is from not hurting/no discomfort/no pain (least pain) to hurting a whole lot/very uncomfortable/severe pain (highest pain). The parent and child place a mark on the line the best describes their satisfaction level.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026