An interventional study of Neutral White Cast and Color Wrapped Cast in Fractures, Bone, sponsored by United States Naval Medical Center, Portsmouth. Recruiting at 1 site in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by United States Naval Medical Center, Portsmouth · Not applicable, Interventional, and Treatment
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:
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.
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 96 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →United States Naval Medical Center, Portsmouth is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
This intervention consists of receiving a cast of neutral white color.
Other: Neutral White Cast
This intervention consists of receiving a cast of color that is the choice of the participant.
Other: Color Wrapped Cast
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
This intervention consists of receiving a cast of neutral white color.
This intervention consists of receiving a cast of color that is the choice of the participant.
This intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork.
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.
Time frame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)
PedsQL Pediatric Pain Questionnaire
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.
Time frame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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United States Naval Medical Center, Portsmouth