为接受包皮环切术的父母及其子女提供小儿外科护理的智能客户驱动解决方案
2019年11月21日 更新者：HE Hong-Gu
开发和测试智能客户驱动的小儿外科护理解决方案对改善接受包皮环切术的父母及其子女结果的有效性
本研究旨在 (1) 为接受包皮环切术的儿童的父母及其子女开发一种以客户为导向的智能小儿外科护理解决方案； (2) 检查干预对父母（儿童护理自我效能、围手术期知识、围手术期护理满意度、信息需求和焦虑）和儿童（术前焦虑和术后疼痛）结局的有效性； (3) 探索使用者（父母、儿童、医护人员）对干预的看法和改进建议。
研究概览
详细说明
目的：本研究的目的是：(1) 为接受包皮环切术 (ICory-Circumcision) 的儿童父母及其子女开发一种智能的、以客户为导向的儿科手术护理解决方案； (2) 检查 ICory-Circumcision 对父母（儿童护理的自我效能、围手术期知识、围手术期护理满意度、信息需求和焦虑）和儿童（术前焦虑和术后疼痛）结果的有效性，如以及手术病例和医疗服务使用的未出现/延迟出现； (3) 探讨使用者（父母、儿童、医护人员）对干预的看法和改进建议。
研究设计：本研究将是一项两组预测试和重复测试后试点随机对照试验，然后进行定性过程评估。 总共 80 对父母及其小学学龄儿童（7-12 岁）将被随机分配到干预组，该干预组将接受 ICory-Circumcision 加常规护理，其中父母将收到 BuddyCare 申请，而孩子将收到 Triumf 游戏应用程序，而对照组仅接受医院提供的常规护理。 将开发并使用访谈指南来采访使用 ICory-Circumcision 的父母和医疗保健专业人员，以探索他们对优势、劣势和需要改进的领域的经验和意见。 使用过 Triumf 游戏的孩子们也将接受采访，探讨他们对游戏应用程序的体验。
假设：与对照组相比，(1) 接受 ICory-Circumcision 的干预组父母将报告显着 (a) 更高水平的儿童保育自我效能；围手术期知识和满意度 (b) 较低水平的信息需求和术前焦虑。 (2) 干预组患儿的术前焦虑和术后疼痛程度显着降低。 (3) 干预组将有更少的未出现/延迟出现手术的案例，并减少卫生服务的使用（例如 手术后 2 周内因非医疗原因减少 A & E 部门或 GP 出勤率）。
研究类型
介入性
注册 (预期的)
160
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Singapore、新加坡、117597
- 招聘中
- National University of Singapore
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接触：
- Hong-Gu He, PhD
- 电话号码：+6565167448
- 邮箱：nurhhg@nus.edu.sg
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
7年 至 12年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
孩子们
纳入标准：
- 年龄在7-12岁之间；
- 计划进行择期包皮环切手术；
- 能够用英语说和读；
- 在围手术期由父母（母亲或父亲或双方）陪同；和
- 可以使用智能手机/平板电脑（自有或从项目租用）。
排除标准：
- 从医疗记录中确定的认知和学习障碍；
- 需要特殊医疗护理的慢性疾病和/或疼痛；
- 从他们的医疗记录中确定的焦虑症和其他情绪障碍；
- 听力或视力障碍；
- 深度知觉缺陷；和/或
- 在过去 6 个月的丧亲期间。
父母
纳入标准：
- 父亲或母亲作为孩子的主要照顾者并符合上述选择标准；
- 年满 21 岁；
- 能够用英语进行口头交流和识字；和
- 可以使用智能手机/平板电脑（自有或从项目租用）。
排除标准：
- 有视觉/听觉障碍；
- 有任何认知障碍/精神障碍，包括焦虑症；
- 已处于疾病末期；和/或
- 在过去 6 个月的丧亲期间。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：干预组
干预组的参与者将接受常规护理以及根据初步研究、其他文献以及最重要的研究医院目前实施的手术路径专门为本研究开发的 ICory-Circumcision。
ICory-Circumcision 计划有两个组成部分：(1) Buddy Healthcare 移动应用程序 (BuddyCare)，它为父母提供有关孩子手术的全面的围手术期日常指南，并为医疗保健专业人员提供一个界面来监控父母和他们的孩子孩子的需求，并与他们沟通。
(2) 为儿童提供情感支持和分散注意力的 Triumf Health 手机游戏应用程序。
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ICory-Circumcision 是根据初步研究、其他文献以及最重要的是研究医院目前实施的手术路径专门为本研究开发的。
ICory-Circumcision 计划有两个组成部分：(1) Buddy Healthcare 移动应用程序 (BuddyCare)，它为父母提供有关孩子手术的全面的围手术期日常指南，并为医疗保健专业人员提供一个界面来监控父母和他们的孩子孩子的需求，并与他们沟通。
(2) 为儿童提供情感支持和分散注意力的 Triumf Health 手机游戏应用程序。
ICory-Circumcision 计划旨在以自我指导和医疗保健专业人士为主导。
从招募时到手术后 2 周，参与者将可以访问 BuddyCare for parents 和 Triumf Health，而医疗保健专业人员将接受有关如何使用 BuddyCare 仪表板的面对面培训。
常规护理包括与医生的正常会诊、术前准备和术后护理。
在第一次咨询期间，将评估孩子是否需要进行包皮环切术，医生会向父母口头解释手术、风险、预期内容和术前准备。
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有源比较器：控制组
对照组的参与者将接受医院提供的常规护理，包括正常的医生会诊、术前准备和术后护理。
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常规护理包括与医生的正常会诊、术前准备和术后护理。
在第一次咨询期间，将评估孩子是否需要进行包皮环切术，医生会向父母口头解释手术、风险、预期内容和术前准备。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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家长术前焦虑与信息需求
大体时间：将在基线（手术前约 2 周）评估父母的术前焦虑和信息需求，并将评估基线与手术前一天之间的变化。
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阿姆斯特丹术前焦虑和信息量表 (APAIS) (Moerman, van Dam, Muller & Oosting, 1996) 将用于测量父母的术前焦虑和信息需求。
APAIS 是一份包含 6 个项目的问卷，包括 4 个关于对麻醉和手术的恐惧的问题，以及 2 个关于信息需求的问题。
调查问卷根据 1 到 5 的李克特量表评分。1 分表示“完全没有”，而 5 分表示“非常”。
焦虑量表的总分范围为 4 至 20，而信息需求量表的范围为 2 至 10。
分数越高，表明受访者的焦虑程度越高，所需信息也越多。
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将在基线（手术前约 2 周）评估父母的术前焦虑和信息需求，并将评估基线与手术前一天之间的变化。
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家长围手术期知识
大体时间：父母的围手术期知识将在基线（手术前约 2 周）进行评估，并将在手术后 2 周评估基线和干预后之间的变化，
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自主开发的家长围手术期知识问卷（PPKQ）用于评估家长对包皮环切手术的知识掌握情况。
它是由研究小组开发的。
内容效度将由 5-10 名专家组成的专家小组完成（Gilbert & Prion，2016）。
PPKQ 包含 10 道多项选择题。
正确回答的问题数量越多，表明对围手术期过程的理解程度越高，因此知识越丰富。
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父母的围手术期知识将在基线（手术前约 2 周）进行评估，并将在手术后 2 周评估基线和干预后之间的变化，
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父母在育儿中的自我效能感
大体时间：父母的自我效能将在基线（手术前约 2 周）进行评估，并将在手术后 2 周评估基线和干预后之间的变化，
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自主开发的父母在儿童围手术期护理中的自我效能感（PSeCPC）问卷将用于衡量父母在整个围手术期护理中的自我效能感。
该量表有 8 个项目，每个项目根据四个回答进行评分：1 = 一点也不自信，2 = 有点自信，3 = 中等自信，4 = 相当自信，5 = 非常自信。
总比分8-40。
得分越高意味着自我效能感越好。
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父母的自我效能将在基线（手术前约 2 周）进行评估，并将在手术后 2 周评估基线和干预后之间的变化，
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家长对围手术期护理的满意度
大体时间：家长对围手术期护理的满意度将在手术后 2 周左右的干预后进行评估。
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将使用 6 点序数描述性量表 - 围手术期护理满意度 (ODS-SPC) 来评估父母对 ICory-Circumcision 和常规护理的满意度。
该量表仅包含一个项目，采用 6 分制，从“非常不满意”1 分到“非常满意”6 分。
总分可以在 1 到 6 之间。
得分越高表明对围手术期护理的满意度越高。
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家长对围手术期护理的满意度将在手术后 2 周左右的干预后进行评估。
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儿童术前焦虑：改良耶鲁术前焦虑量表 - 简表 (mYPAS-SF)
大体时间：儿童的术前焦虑将在手术前一天进行评估。
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改良耶鲁术前焦虑量表 - 简表 (mYPAS-SF)（Jenkins、Fortier、Kaplan、Mayes & Kain，2014 年）将用于测量手术前儿童的术前焦虑水平。
它是一个 4 项量表（活动、发声、情绪表达、明显觉醒状态），并通过观察填写。
总分在 23 到 100 之间。
分数越高意味着焦虑程度越高。
31 分及以上表示高度焦虑（Kain 等人，1997 年；Rema、Cavaleiro、Pina 和 Machado，2016 年）。
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儿童的术前焦虑将在手术前一天进行评估。
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儿童术后疼痛：面部疼痛量表
大体时间：将在手术后 24 小时测量儿童的术后疼痛。
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面部疼痛量表 - 修订版 (FPS-R)（国际疼痛研究协会 [IASP]，2001 年）将用于评估儿童的术后疼痛。
FPS-R 显示了六张不同面部表情的面孔，孩子被指示指向与他当时感受到的疼痛程度相对应的面孔。
分数范围为 0-10，分数越高表示疼痛越严重。
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将在手术后 24 小时测量儿童的术后疼痛。
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健康服务使用
大体时间：将在手术后 2 周左右评估医疗服务的使用情况。
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医疗服务使用情况将通过医疗服务使用问卷 (HSUQ) 进行评估，以获取每个参与者的资源使用情况出院后信息，例如
急诊室出勤，以及全科医生/私人诊所的计划外医疗咨询。
最小服务使用将为零，但没有最大限制。
服务使用的价值越高表明结果越差。
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将在手术后 2 周左右评估医疗服务的使用情况。
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过程评估
大体时间：过程评估将在手术后2周左右进行。
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过程评估将通过半结构化访谈进行评估。
将使用半结构化采访指南采访干预组（目标 15-30 岁）的父母和儿童以及使用 ICory-Circumcision 的医疗保健专业人员。
家长和孩子将被问及应用程序的内容、活动和交付方法以及有用性。
医疗保健专业人员将被问及该应用程序的优缺点以及他们从他们的角度对该应用程序的看法。
这是一个定性数据，将通过主题分析对数据进行分析。
因此，本次评价不设分值。
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过程评估将在手术后2周左右进行。
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Hong-Gu HE, PhD、National University, Singapore
- 首席研究员：Vidyadhar P Mali, PhD、National University Hospital, Singapore
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有用的网址
- Smartphones in Singapore: A whitepaper release
- Singapore census of population 2010, statistical release 1: Demographic characteristics, education, language and religion.
- Statistics on telecom services for 2017 (Jan-Jun)
- Faces pain scale - revised home
- Buddy Healthcare joining the ICory project. Buddy Healthcare
- Research Electronic Data Capture
- Research Randomizer
- State-Trait Anxiety Inventory (STAI): Mind Garden
- Play is the way to healthier life.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年11月1日
初级完成 (预期的)
2020年10月31日
研究完成 (预期的)
2020年10月31日
研究注册日期
首次提交
2019年11月20日
首先提交符合 QC 标准的
2019年11月21日
首次发布 (实际的)
2019年11月22日
研究记录更新
最后更新发布 (实际的)
2019年11月25日
上次提交的符合 QC 标准的更新
2019年11月21日
最后验证
2019年11月1日
更多信息
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