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.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 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:
- To evaluate the willingness to use the AR app,
- To evaluate the time spent using the AR app (recorded in the study device),
- To calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel,
- To evaluate app recorded responses to pain intensity,
- To evaluate app recorded responses to nausea intensity,
- To assess the frequency of vomiting,
- To measure the length of stay in PACU (calculated from the EMR),
- To determine the rate (number) of assessments completed,
- To calculate PACU opioid use,
- To calculate opioid use during hospitalization,
- To assess the quality of life using the PedsQL Cancer Module survey responses (administered by the study team),
- To evaluate patient/caregiver satisfaction following the PACU stay
- 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
- 否
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.
排除标准
- •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.
研究组 & 干预措施
Augmented reality (AR)
Experimental
Augmented reality (AR)
Participants will view the real world through a device's camera and application ("app") but adds virtual or digital characters and items to the image
干预措施: Augmented reality (AR) (Other)
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
研究点 (1)
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