跳至主要内容
临床试验/NCT05933252
NCT05933252已完成不适用

A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Activation and use of the technology (YES versus NO)

研究概览

简要总结

The feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in English or Spanish-speaking pediatric cancer patients.

详细描述

Primary Objective:

To determine the feasibility of administering an AR-based electronic tool to assess postoperative pain, nausea, and vomiting in English or Spanish-speaking pediatric patients with neoplastic conditions.

Secondary Objectives:

  1. To evaluate the willingness to use the AR app,
  2. To evaluate the time spent using the AR app (recorded in the study device),
  3. To calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel,
  4. To evaluate app recorded responses to pain intensity,
  5. To evaluate app recorded responses to nausea intensity,
  6. To assess the frequency of vomiting,
  7. To measure the length of stay in PACU (calculated from the EMR),
  8. To determine the rate (number) of assessments completed,
  9. To calculate PACU opioid use,
  10. To calculate opioid use during hospitalization,
  11. To assess the quality of life using the PedsQL Cancer Module survey responses (administered by the study team),
  12. To evaluate patient/caregiver satisfaction following the PACU stay
  13. To assess nursing experience with AR tool following patient discharge from PACU.

Exploratory Objectives:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 7-17 years old,
  • Able to provide assent, and a legal guardian able to provide informed consent
  • Current diagnosis of pediatric cancer or benign neoplasm,
  • Surgery with an estimated duration longer than 2 hours,
  • An expected prescription of opioids during the inpatient perioperative period
  • Demonstrate capacity to comprehend and interact with the game in English or Spanish.
  • Exclusion criteria:
  • Any concerns from the principal investigator or primary team about the use of the app,
  • Inability or refusal from the parents to provide written informed consent.

排除标准

  • 未提供

结局指标

主要结局

Activation and use of the technology (YES versus NO)

时间窗: through study completion; an average of 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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