该研究的重点是使用 BLS -AHA 2020 使用模拟培训新入职护士,分为干预(模拟培训)和控制(手册)两组,测试包括预测试和 2 次测试后调查,以评估知识、实践和信心水平。 (BLS-NEN-HCP)
协议标题:约旦政府医院新聘护士基本生命支持培训 (SBLST) 模拟有效性的开发、验证和评估。
本研究的总体目标是开发、验证和评估模拟在约旦政府医院新聘护士基础生命支持培训(SBLST)中的有效性;研究设计是基本的实验研究设计、随机对照试验(RCT)设计、本研究中的因变量测量;通过一次预测试和两次后续测试,两组人参与本研究的知识、实践和信心;实验组和对照组。 对照组治疗是标准干预(手册),实验组干预是模拟基本生命支持训练(SBLST)。 研究过程包括四个步骤
- 执行预测试(评估知识、练习信心调查
- 教育干预知识与实践
- 执行后测 1(评估知识、练习信心调查
- 执行后测 2(评估知识、练习信心调查
研究概览
详细说明
本研究的总体目标是开发、验证和评估模拟在约旦政府医院新聘护士基础生命支持培训(SBLST)中的有效性;研究设计是基本的实验研究设计、随机对照试验(RCT)设计、本研究中的因变量测量;通过一次预测试和两次后续测试,两组人参与本研究的知识、实践和信心;实验组和对照组。 对照组治疗为标准干预(手册),实验组干预为模拟基本生命支持训练(SBLST);研究人员假设对照组和实验组在纳入标准和预测试分数上没有显着差异;此外,基本生命支持培训干预的模拟显着提高了约旦政府医院新聘护士(NEN)的知识、实践和信心水平;此外,对照组和实验组在所有因变量的后测分数上均存在显着差异。 研究过程包括四个步骤
- 执行预测试(评估知识、练习信心调查
- 教育干预知识与实践
- 执行后测 1(评估知识、练习信心调查
- 执行后测 2(评估知识、练习信心调查
研究标题:
约旦政府医院新聘护士基本生命支持培训 (SBLST) 模拟效果的开发、验证和评估
研究假设 i. 基础生命支持培训干预的模拟有效提高了约旦公立医院新聘护士(NEN)的知识。
二. 基础生命支持培训干预的模拟有效改善了约旦政府医院新聘护士(NEN)的实践。
三. 基础生命支持培训干预的模拟有效提高了约旦公立医院新聘护士(NEN)的信心水平。
四. 干预组和对照组新聘护士(NEN)预检验的所有因变量均值均无显着差异。
v. NEN 中所有因变量的 PRE-SBLST 和所有 POST-SBLST 结果之间存在显着的平均差异。
研究设计本研究设计为前瞻性、纵向、单盲基础实验设计、随机对照试验(RCT)设计。
研究地点 该研究在约旦、安曼和扎尔卡市进行。 五家医院的可访问人群为 NEN。 研究人员选择了三家约旦医院。 选择是根据机构的能力、能力和资格标准进行的。 计算机生成的随机化(随机分配软件,版本 1.0)被应用于区块中,通过将医院分配到两个组中来分配医院。 第一组是对照组;选自三家医院;哈姆扎王子医院、AL-Basheer 医院和 AL-Zarqa 政府医院(n=51);第二组是两家医院的介入组;费萨尔亲王政府医院和 Dr.Jameel AL-Totanji 医院。
医院的随机化 为了防止对照组和干预组之间的数据污染,计算机生成的随机化(随机分配软件,版本 1.0)被分批应用,通过将医院分成两组来分配医院。 第一组是对照组;选自三家医院;哈姆扎王子医院、AL-Basheer 医院和 AL-Zarqa 政府医院(n=51);第二组是两家医院的介入组;费萨尔亲王政府医院和 Dr.Jameel AL-Totanji 医院。 对照组和干预组是从不同的医院选择的,因为研究人员总是担心数据污染,并试图尽量减少对照组和干预组之间的数据污染;如果样本是从同一地区选取的,并且两个小组密切合作,那么数据就会受到污染。
该研究包括预测试、干预、干预后立即的后测试 1 和干预后三个月的后测试 2。 这项研究通过对照组和实验组的前后测试来衡量知识、实践和信心。 本研究使用了两种干预措施:干预组采用 SBLST,对照组采用 AHA-BLS 2020 手册作为标准治疗。 使用 Google Form Platform(一种受 Google 应用程序版权所有的基于网络的工具)进行数据收集。
评估过程包括一次预测试和两次后续评估,以衡量知识、实践和信心。 研究人员将分析每次测试的手段;因变量总数为 30 个问题。
研究仪器
工具语言 根据 HCP 教育水平,工具评估的所有四个部分均以英语编写;此外,研究人员还向参与者澄清了任何误解点或需要翻译的问题。
工具部分 工具由五个部分组成;研究信息表和同意书、人口统计数据、知识评估工具、技能评估工具和置信度评估工具。
研究信息表和同意书 研究信息表是一份简短的研究人员信息和联系方式;它还包括受试者信息和同意书,其中有参与者在被批准参加本研究时签名的区域。 此外,研究信息表包括参与者的发表同意书。
人口统计数据 人口统计部分附后;这些数据由二分问题(是\否)、名义数据、序数数据和区间测量问题组成。 名义测量包括性别和顺序评估,如教育水平和经验领域;间隔评估问题包括年龄和工作经验。 二分评估(是\否),询问参与者之前是否参加过 CPR 活动或观察过任何 CPR、参与者是否之前使用模拟完成过 BLS 培训以及参与者是否获得了正式和认可的 BLS 培训认证机构。
知识与实践 护理知识是科学与研究的相互作用,以改进实践。 研究人员使用包含 13 个问题的 MCQ 工具来评估知识。 护理实践是把以前所学的知识运用起来;研究人员使用由 10 个 MCQ 组成的工具评估技能。 参与者每个错误答案得零分,每个正确答案得一分。
信心 信心是通过知识获取、技能和批判性思维来建立和成就护理职业。 信心是对患者进行 BLS 的积极信念和可靠性,无需恐惧且无风险。 研究人员使用七种陈述来评估置信水平,这些陈述被评为百分比值从最低值 5% 到最高值 100% 的下降。
研究过程步骤
- 预测试 NEN按照对照组和实验组的纳入标准(n=102)入组后,参与者首先签署知情同意书、填写人口统计数据和预测试作为干预前的主动步骤;根据医院护理主任的安排,根据NEN的可用性进行了多次预测试数据收集和干预。 填写人口统计数据和预测试的预计时间约为 30 分钟。 奥尔曼等人。 (2020) 指出,培训师进行预测试评估,以评估 SBLST 的有效性。 研究人员与对照组讨论了研究的目的,并向他们解释了防止任何数据污染并尽量减少其他研究助理对调查内容的解释的程序。
干预 对照组在进行后测前阅读包含基本生命支持简要指南的小册子 30-60 分钟。 标准治疗时间为2022年12月至2023年1月。 根据最近的研究并使用 AHA-2020 指南,需要一整天的 SBLST 干预,即 5 至 7 小时的 SBLST 干预。 每场的参加人数为 10 NEN。 介入治疗由理论和实践两部分组成。 SBLST干预是根据医院的能力在教育实验室进行的; SBLST从2022年11月22日到2022年12月20日运行了7天。
研究人员在 SBLST 中结合了两个框架。 米勒金字塔和科尔布循环;米勒金字塔侧重于通过模拟教授任务的理论和实践方面,并允许受训者在指导下独立执行该程序;科尔布循环建议为学习者提供一个场景进行练习,直到他们消除错误,然后再转向另一个场景。 SBLST 干预措施经过了 BLS 的三位专家的审查,并得到了约旦卫生部生命支持中心的批准。 它被认为是合规、安全的,并且涵盖了 AHA-2020 的所有方面。 英语专家提供了反馈以提高清晰度。 对 20 名护士进行了一项试点研究,以计算 SBLST 时间、识别错误、监控进度并计算 Cronbach's Alpha。进行试点研究是为了检查工具的稳定性。 知识和技能评估工具的Cronbach's alpha为0.748,反映了使用这些工具的适用性和强度。 此外,置信工具的Cronbach's alpha为0.731,反映了置信工具的适用性和稳定性。
需要成人半身模型和儿童全身模型;具有肺袋充气和放气特性,可触及颈动脉搏动,胸腔内有弹簧以方便胸部反冲,胸腔压缩板,袋-阀-面罩-通气,在查理模拟器上进行胸腔压缩以缓解窒息。 主要研究者(PI)拥有重症监护护理硕士学位,在 ICU、讲师和临床讲师之间有十八年的经验,有效的 BLS 和 ACLS、护理教育培训师培训以及随机对照试验培训。 辅导员必须拥有 BLS 和 ACLS 的 CPR 认证、足够的教育和培训专业知识以及良好的沟通技巧。 调查员拥有重症监护硕士学位。 两名研究助理协助 PI 收集数据;一名研究助理负责对照组,另一名研究助理负责干预组。
- 后测试 所有参与者在干预后立即完成后测试 1。 post-tets-2 是通过参与者的电话和电子邮件地址向其提供 Google Form Platform 链接来进行的。 三个月后的后测试通过比较所有后测试之间的平均值来评估参与者的水平是否保持在同一水平或最小化。 实验组中有 48 名参与者完成了后测试 2,响应率为 94%,对照组有 45 名参与者,响应率为 88%。
样本量估计使用G*POWER软件(3.1版)进行样本量计算;样本量计算总结如下:(1)选择检验族(F检验族),(2)选择统计检验(选择ANOVA-重复检验,因素间),研究者使用的初步检验分析在本研究中,由于在不同时间点测量许多因变量均值,因此在因素之间使用选择方差分析重复检验的基本原理。 (3)计算样本量选择的参数包括一侧尾部、alpha(α)和等于(0.05)-型一误差、Power(P)和等于(0.8)、效应大小、组数为两个(每个group = n\2) n= 估计的样本量,测量次数为四次测量(前测试、立即后测试、两个月后测试后和三个月后测试后)。
效应量(ES)=0.26,由G*Power软件自动计算,根据前期研究的样本量,计算效应量,对照组测后结果M±SD相等(25.03±3.04) 样本量为28人,干预组为(26.64±2.64) 样本量为 29 名参与者。 样本量为 72 名参与者;因为研究持续了三个月,所以研究人员每个月增加了10%的下降率,所以下降率为30%。 最终样本量估计,包括脱落率(n\1-脱落率)= 72/(1-0.30) = 102 名参与者,干预组有 51 名参与者,最大样本量来自干预组,多于对照组和对照组 51 名参与者。
对参与者进行简单随机抽样在获得约旦卫生部的伦理批准和进行研究的许可、批准函(教育/信息\ 15177)和伦理批准函(MOH/REC/2022/340)后,研究人员开始与所选医院的护理主任和继续教育办公室进行正式的面对面访问,了解研究目标以及研究如何进行;研究人员收到了启动研究的激活信,并准备了符合研究资格标准的可用参与者名单。 参与者的数量取决于机构中符合纳入标准的新聘护士的数量。 研究人员从各医院新聘护士中随机抽取参与者,从参与者名单中随机抽取参与者,作为干预组和对照组。
。对照组医院的反应如下:扎尔卡政府医院的护理主任和继续教育部门的回应是,提供了有关参与者的所有信息,并选择了进行预测试、标准治疗和立即后测试的时间和日期。 Prince Hamzah医院和AL-Basheer医院向研究人员提供了医院内包括NEN的科室名称,研究人员访问这些科室随机选择可用的NEN并进行预检测、标准治疗和立即检测后在他们的部门。
介入组医院的答复如下:费萨尔亲王政府医院和 Jameel AL-Totanji 医院安排了许多天和多次进行干预,医院安排了符合资格标准的可用参与者;然后,研究人员随机选择参与者。
道德考虑
- 进行研究的许可出于伦理方面的考虑,该研究获得了马来西亚理科大学(USM)人类研究伦理委员会(HREC)的批准。 此外,约旦卫生部还获得了在安曼和扎尔卡市的约旦医院启动 SBLST 干预的伦理批准;研究方案经 Jawatankuasa Etika Penyilidikan Manusia Universiti Sains Malaysia (JEPeM-USM) 修订并批准实施,研究方案代码为 USM/JEPeM/22110681,符合赫尔辛基宣言、国际协调会议 (ICH) 指南、良好临床实践 (GCP) 标准、国际医学科学组织理事会 (CIOMS) 指南、世界卫生组织 (WHO) 健康相关研究伦理审查以及调查和评估伦理审查实践的标准和操作指南、EC/IRB 标准操作道德审查程序 (SOP) 以及地方法规和标准。
主题漏洞 本研究中没有漏洞组。 所有参与者均为20岁以上在医院工作的护士;没有参与者有残疾或身体问题。 参与者自愿选择参加试验。 研究人员讨论了该研究的目标、方法、益处和风险。 该研究对参与者不存在任何潜在危害或不良影响,未在紧急情况下进行干预,并且本研究中不会使用任何药品。 程序很简单,干预中使用的设备是安全的,并且指示调查人员经常询问参与者的健康和身体状况,特别是在胸外按压期间。
签署纸质同意书的参与者是本试验研究的一部分。 在所有研究阶段,将使用电子方法询问参与者; Google Form Platform,如果他们愿意参与这项研究,他们会在完成调查问卷之前回答(是\否)。 此外,干预措施将应用于模拟;参与者自愿退出研究,对年度评估或薪资没有任何影响或影响。 这些机构对试验和保护参与者负全部责任,并在出现意外不良影响或身体伤害时对参与者进行治疗。
该研究对参与者的风险最小,可以通过干预的时间长度和组成部分观察到;参与者可能会感到不适。 这种风险相当于护士的日常生活活动。 它们可以以最小的风险进行调整;只有四个部分需要很长的时间来涵盖干预中的知识和实践,但其他四个部分很简单,需要很短的时间。 研究人员计划通过在干预措施之间给予参与者“休息时间”,尽量减少参与者因干预时间和长度而产生的不适。
- 无利益冲突声明研究人员声明不存在利益冲突,所有合著者均无需要报告的经济利益。 研究人员证明第一作者纯粹是博士。学生的原创作品,尚未提交给其他大学或期刊。
- 隐私和保密 研究完成后,试验主档案和文件均受到保护并妥善保管,所有记录均予以保密。 此外,收集的数据不会通过姓名与个人相关联,而仅通过电话号码和电子邮件与他们联系,以便稍后与他们联系以完成后测试;数据仅在研究中得到妥善保存和处理。 此外,研究人员还强调,只有研究小组才能访问本研究中的相关数据,未经参与者同意,未来不得使用;并且,研究完成后,数据将按照政策妥善归档。
- 社区敏感性和益处 NEN 作为争议性教育一部分的干预益处,以及通过课堂自然学习过程、面对面学习以及使用电子方法、Google Forms 填写的调查问卷分享的知识和实践平台;没有有关参与者的敏感信息。 本研究结果对参与者的主要好处是提高新聘护士在面临医院内外危急情况时的知识、实践技能和信心水平,提高所有医疗保健服务系统的专业性、自尊心,提高新聘护士的水平' 绩效能力、决策能力、满意度,以减少失误和不满。 此外,这项研究的好处是开发患者护理流程,提高受害者的生存率和患者满意度,维护患者安全,提高福利和出院结果,对患者及其家人来说具有成本效益,并使患者远离危险。
- 奖励与报销 研究者口头感谢所有参与者在完成后的真诚合作。 此外,研究人员计划在选定的一天对对照组进行 SBLST;最后,参与者收到了研究人员关于事前和事后结果的反馈以及4小时的认证出勤,这增加了年度自我评估表中所需的工作发展时间。
- 合作研究职权范围:无
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Amman、约旦、11118
- Ministry of Health
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
纳入标准 研究人员试图通过以下方式保持参与者的同质性并尽量减少参与者之间的差异:
- 从新聘护士中选择干预组和对照组
- 男性和女性参与者
- 仅限理解英语问卷和干预措施的参与者
- 过去两年,2020 年(四年级护理学士学位)和 2021 年(三年级护理学士学位)在 COVID-19 大流行期间通过在线方法接受基础和临床学习的参与者,现在成为医院新聘护士(NEN),为病人提供护理。
- 参与者可以参加五到七小时的 SBLST 课程。
- 为了更好地控制,我们选择了过去两年很少接受心肺复苏且不参加 BLS 的护士。
排除标准
- 研究人员排除了在重症监护室工作的 NEN 参与者,因为 ICU 护士每天都要进行心肺复苏并进行 BLS。
- 排除有医疗或身体健康问题的参与者(例如孕妇和抱怨腰痛的参与者)。
- 两年前参加心肺复苏术培训的参与者也被排除在外。 最后,
- 学历从文凭升级为学士学位的 NEN 被排除在外。
学习计划
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:世博思特集团
治疗(B):基本生命支持训练模拟 介入工具、基本生命支持训练模拟(SBLST)是用英语准备的。
研究人员将使用 2020 年美国指南中已经建立的 BLS 培训,该培训简化为两部分; PowerPoint 演示和临床模拟培训。
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介入工具,基本生命支持训练模拟(SBLST),是用英语准备的。
研究人员将使用 2020 年美国指南中已经建立的 BLS 培训,该培训简化为两部分; PowerPoint 演示和临床模拟培训。
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有源比较器:标准组
研究者将给对照组的参与者;使用 AHA-BLS 2020 手册进行标准治疗。
参与者将在 30 分钟内阅读并理解本手册,包括有关基本生命支持指南的简要指南,30 分钟后,参与者将进入后测试。
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参与者将在 30 分钟内阅读并理解本手册,包括有关基本生命支持指南的简要指南,30 分钟后,参与者将进入后测试
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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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模拟在基础生命支持训练 (SBLST) 中对知识得分的有效性
大体时间:完成所有数据收集后 6 个月
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为了评估 SMBST 对知识分数的有效性,研究人员将对实验组和对照组进行三项测量:预测试、干预后立即进行的后测试以及三个月后的后测试 2。
参与者将通过 Google Form Platforms 收到一份包含 13 个 MCQ 的调查问卷 3 次。
这些问题将发送到他们的手机号码。
将对两组进行重复测量方差分析,并比较前测和后测之间的平均知识得分。
显着性水平将由接受或拒绝备择假设的 p 值决定(基本生命支持培训干预的模拟提高了约旦政府医院新聘护士 (NEN) 的知识)。
该干预措施具有教育意义,不会对参与者造成风险或不利影响。
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完成所有数据收集后 6 个月
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模拟在基本生命支持训练 (SBLST) 中对练习分数的有效性
大体时间:完成所有数据收集后 6 个月
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研究人员进行了三项测量来评估 SMBST 对练习分数的有效性;实验组和对照组均进行前测试、干预后立即测试以及干预三个月后的后测试 2。
练习问卷由 10 个 MCQ 组成,参与者将回答 3 次;这些问题将作为来自 Google Form Platforms 的链接发送到参与者的手机号码,在测试之外的家庭、实验组和对照组的方差分析中,然后比较两组练习分数之间以及测试前和测试后之间的平均值,最终通过 p 值确定显着性水平,以拒绝或接受备择假设“基本生命支持培训干预的模拟有效地改善了约旦政府医院新聘护士 (NEN) 的实践。”
干预是教育性的,对参与者没有不利影响或风险。
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完成所有数据收集后 6 个月
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基本生命支持训练 (SBLST) 置信度模拟的有效性
大体时间:完成所有数据收集后 6 个月
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SMBST 在置信水平上的有效性将通过测量实验组和对照组的预测试、即时后测试和后测试 2 结果来评估。
参与者将使用发送到他们手机上的 Google 表单链接完成调查三次。
重复测量方差分析将用于分析数据并比较各组之间的平均置信水平和测试前/测试后分数。
事实证明,该干预措施可有效提高信心水平,且无不良影响或风险。
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完成所有数据收集后 6 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
对照组和实验组在知识分数预测方面没有显着差异
大体时间:两组预测试完成后2个月
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在对实验组和对照组实施任何干预之前,研究者确保两组的预测试水平显着相似,以确保测量准确。
在进行方差分析并与平均值、标准差 (SD) 和 P 值结果进行成对比较后,研究者将决定该假设。
该干预措施具有教育意义,不会对参与者造成不利影响或风险。
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两组预测试完成后2个月
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练习成绩预测中对照组与实验组无显着差异
大体时间:两组预测试完成后2个月
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在对实验组或对照组实施任何干预之前,研究者采取措施确保两组具有可比较的预测试分数,从而保证测量的精确性。
该假设的有效性将通过 ANOVA 分析得到证实,其中将使用成对比较来比较平均值、标准差 (SD) 和 P 值。
值得注意的是,所提供的教育干预不会给参与者带来任何风险或不利影响。
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两组预测试完成后2个月
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在预测试中,对照组和实验组之间的置信水平没有显着差异。
大体时间:两组预测试完成后2个月
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在进行任何干预之前;和实验组,研究者确保两组的预测显着处于同一水平,以保证测量的准确性;研究者将在 ANOVA 分析后决定这一假设,并使用平均值、标准差 (SD) 和 P 值结果进行成对比较。
干预是教育性的,对参与者没有不利影响或风险。
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两组预测试完成后2个月
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在知识得分的后测中,对照组和实验组之间存在显着差异。
大体时间:完成所有数据收集后 6 个月
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研究者将通过比较测试后均值和 SD 来评估 SBLST 对实验组的有效性,并评估对照组和实验组的显着性水平(p 值),以使用重复方差分析确定 SBLST 对知识评分有效测量分析。
干预是教育性的,对参与者没有不利影响或风险。
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完成所有数据收集后 6 个月
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练习成绩干预后,对照组和实验组在后测中存在显着差异
大体时间:完成所有数据收集后 6 个月
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研究者将通过比较测试后均值和 SD 来评估 SBLST 对实验组的有效性,并评估对照组和实验组的显着性水平(p 值),以使用重复方差分析来确定 SBLST 对练习分数有效测量分析。
干预是教育性的,对参与者没有不利影响或风险。
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完成所有数据收集后 6 个月
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置信水平干预后的后测中对照组和实验组之间存在显着差异
大体时间:完成所有数据收集后 6 个月
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研究者将通过比较测试后平均值和 SD 来评估 SBLST 对实验组的有效性,并评估对照组和实验组的显着性水平(p 值),以使用 ANOVA 重复测量来确定 SBLST 在置信水平上有效分析。
干预是教育性的,对参与者没有不利影响或风险。
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完成所有数据收集后 6 个月
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
对照组和实验组的纳入标准没有差异
大体时间:两组预测试完成后2个月
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研究人员为对照组和实验组选择了纳入标准,通过使用 Mann-Witney U 检验并检查中位数和智商范围,两组的人口统计数据应该是同质的。
干预是教育性的,对参与者没有不利影响或风险
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两组预测试完成后2个月
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合作者和调查者
出版物和有用的链接
一般刊物
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