跳至主要内容
临床试验/NCT06990555
NCT06990555招募中不适用

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

United States Naval Medical Center, Portsmouth1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
96
试验地点
1
主要终点
Visual Analog Scale for Satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Neutral White Cast

Other

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

干预措施: Neutral White Cast (Other)

Color Wrapped Cast

Other

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

干预措施: Color Wrapped Cast (Other)

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.

干预措施: Cast with Cast Art (Other)

结局指标

主要结局

Visual Analog Scale for Satisfaction

时间窗: 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.

次要结局

  • PedsQL Pediatric Pain Questionnaire(0-2 weeks post injury, 4-6 weeks, and 8-12 weeks (if indicated))

研究者

发起方
United States Naval Medical Center, Portsmouth
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Vanna Rocchi

PI

United States Naval Medical Center, Portsmouth

研究点 (1)

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