ESWL患者的结构化患者教育 (ESWL-VAS-STAI)
结构化患者教育对体外冲击波碎石术患者焦虑水平和生活质量的影响:一项随机对照试验
研究概览
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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Lecturer
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Konya、Lecturer、土耳其(türkiye)、42020
- Konya City Hospital, Department of Urology
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
入选标准:
年龄在18至65岁之间,确诊为尿石症,计划进行择期体外冲击波碎石术(ESWL),首次接受ESWL治疗。
排除标准:
既往有ESWL治疗史,需要紧急干预的尿石症病例,存在肾功能不全、活动性尿路感染、凝血功能障碍或严重心肺合并症,无法停用抗凝或抗血小板治疗,妊娠。
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Control Group - Standard Patient Information
Patients in the control group received routine care in accordance with the institution's ESWL procedures.
Standard pre-procedure information, including brief verbal instructions, was provided by clinical staff.
Control group participants were provided with educational materials after the study was completed for ethical reasons.
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实验性的:Intervention Group - Nurse-Led Structured Patient Education
A structured patient education program led by nurses was implemented for patients in the intervention group, covering the period before and after the ESWL procedure.
The education program was prepared in line with current scientific studies related to the urolithiasis guidelines published by the European Association of Urology and the American Urological Association.The content validity of the educational materials was assessed by expert opinion.
The draft modules prepared in this context were presented to a five-member expert panel comprising two urology nurses, a surgical nursing academic, a nurse with experience in patient education, and a urology specialist.
Each expert was asked to evaluate each module using a 4-point rating system for content appropriateness, scientific accuracy, comprehensibility, and clinical applicability.
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Training program content
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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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Primary Outcome:
大体时间:Baseline (pre-procedure) and 4 weeks after discharge
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One of the methods used to assess anxiety level, the State-Trait Anxiety Inventory (STAI), was developed by Spielberger in 1983 and adapted into Turkish by Öner and Le Compte. The STAI consists of two subscales, each with 20 items, that assess state and trait anxiety levels. All items on the scale are four-point Likert-type. Total scores on the scale range from 20 to 80, with higher scores indicating higher anxiety levels. The Short Form-12 (SF-12) Health Status Questionnaire, used to assess quality of life, was developed by Ware and colleagues as part of the Medical Outcomes Study. The scale consists of two summary components: physical and mental health . Total scores range from 0 to 100, with higher scores indicating better quality of life. The Turkish validity and reliability study of the scale was conducted by Soylu and Kütük. |
Baseline (pre-procedure) and 4 weeks after discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Secondary Outcome:
大体时间:Baseline (pre-procedure), post procedure and 4 weeks after discharge.
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Pain level was determined as the secondary outcome variable.
Pain intensity was assessed using the VAS, a valid and reliable measurement tool.
The scale consists of a 10 cm horizontal line, where 0 indicates "no pain," and 10 indicates "unbearable pain."
Pain measurements were taken before the procedure, after the procedure, and at 4 weeks post-discharge.
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Baseline (pre-procedure), post procedure and 4 weeks after discharge.
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合作者和调查者
调查人员
- 首席研究员:Cemile Nida Kayış、KTO Karatay University
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ESWL-EDU-RCT-2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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