Cast Art for Kids With Extremity Fractures

NCT06990555 | Recruiting

• 1 other identifier: 939056
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone

Keywords

Cast; Art; Fractures

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale for Satisfaction

  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.

  0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)

Secondary Outcomes (1)

• PedsQL Pediatric Pain Questionnaire

  0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)

Study Arms (3)

Neutral White Cast

OTHER

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

Other: Neutral White Cast

Color Wrapped Cast

OTHER

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

Other: Color Wrapped Cast

Cast with Cast Art

OTHER

This intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork.

Other: Cast with Cast Art

Interventions

Neutral White Cast OTHER

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

Neutral White Cast

Color Wrapped Cast OTHER

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

Color Wrapped Cast

Cast with Cast Art OTHER

This intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork.

Cast with Cast Art

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age 18 years old or greater at the time of screening
• Patient/parents do not consent to being included in the study
• Underwent surgery

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

POLR1G protein, human

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: May 8, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)