Fractures, BoneCAKE POPNCT06990555
Cast Art for Kids With Extremity Fractures
A study testing Neutral White Cast, Color Wrapped Cast and Cast with Cast Art in people with Fractures, Bone, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- Neutral White Cast, Color Wrapped Cast and Cast with Cast Art
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Kersten Wheeler, MS, 757-953-5939, kersten.n.wheeler.civ@health.mil
Vanna Rocchi, DO
About this study
Official title: Cast Art for Kids With Extremity Fractures on Satisfaction and Perception of Pain (CAKEPOP)
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
Read more
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.
Read the 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.
- Conditions
- Fractures, Bone
- Being tested
- Neutral White Cast, Color Wrapped Cast, Cast with Cast Art
- Keywords
- Cast, Art, Fractures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral White CastOther
This intervention consists of receiving a cast of neutral white color.
Color Wrapped CastOther
This intervention consists of receiving a cast of color that is the choice of the participant.
Cast with Cast ArtOther
This intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork.
| Study group | Role | What they receive |
|---|---|---|
| Neutral White Cast | Other | This intervention consists of receiving a cast of neutral white color. Receives: Other: Neutral White Cast |
| Color Wrapped Cast | Other | This intervention consists of receiving a cast of color that is the choice of the participant. Receives: 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. Receives: Other: Cast with Cast Art |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start8 May 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Vanna Rocchi, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990555
- Sponsor's protocol ID
- 939056
- Acronym
- CAKE POP
- Status last verified
- Oct 2025
- First submitted
- 16 May 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cast Art for Kids With Extremity Fractures on Satisfaction and Perception of Pain (CAKEPOP)
- ClinicalTrials.gov ID
- NCT06990555
- Acronym / sponsor ID
- CAKE POP / 939056
- Conditions
- Fractures, Bone
- Keywords
- Cast, Art, Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral White Cast | Other | Other: Neutral White CastThis intervention consists of receiving a cast of neutral white color. |
| Color Wrapped Cast | Other | Other: Color Wrapped CastThis intervention consists of receiving a cast of color that is the choice of the participant. |
| Cast with Cast Art | Other | Other: Cast with Cast ArtThis intervention consists of receiving a cast with art at the request of the participant, to include drawing, multiple colors, glitter, and any artwork. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age 18 years old or greater at the time of screening
- Patient/parents do not consent to being included in the study
- Underwent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral White CastThis intervention consists of receiving a cast of neutral white color. | Other | Neutral White Cast |
| Color Wrapped CastThis intervention consists of receiving a cast of color that is the choice of the participant. | Other | Color Wrapped Cast |
| Cast with Cast ArtThis 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 |
Primary outcome
Visual Analog Scale for Satisfaction
Time frame: 0-2 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.
1 secondary outcome
PedsQL Pediatric Pain Questionnaire
Time frame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naval Medical Center Portsmouth
Portsmouth, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral White Cast, Color Wrapped Cast and Cast with Cast Art in people with Fractures, Bone, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Satisfaction (time frame: 0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.