Cast Art for Kids With Extremity Fractures
ConditionFractures, Bone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorUnited States Naval Medical Center, Portsmouth
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Age 18 years old or greater at the time of screening
Patient/parents do not consent to being included in the study
Underwent surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Neutral White Cast
Other interventionThis intervention consists of receiving a cast of neutral white color.
Color Wrapped Cast
Other interventionThis intervention consists of receiving a cast of color that is the choice of the participant.
Cast with Cast Art
Other interventionThis intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Neutral White CastOther 1 intervention
Group B: Color Wrapped CastOther 1 intervention
Group C: Cast with Cast ArtOther 1 intervention
Trial outcomes
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.
Time frame
0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)Secondary outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov