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# Registration date Revision Id
2 2026-05-26, 1405/03/05 383494
1 2026-05-17, 1405/02/27 378349
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  • Protocol summary

    1. Design and develop a "Simplified Tracheostomy Care Package" based on valid scientific evidence. 2. Determine the impact of implementing a "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units.
    Designing and developing a simplified tracheostomy care package based on valid scientific evidence and evaluating its impact on the self-efficacy and performance of nurses working in intensive care unit
    1. طراحی و تدوین "بسته مراقبتی تراکئوستومی ساده‌سازی‌شده" بر اساس شواهد معتبر علمی. 2. تعیین تأثیر به‌کارگیری "بسته مراقبتی تراکئوستومی ساده‌سازی‌شده" بر خودکارآمدی و عملکرد پرستاران شاغل در بخش‌های مراقبت ویژه.
    طراحی و تدوین بسته مراقبتی تراکئوستومی ساده‌سازی‌شده بر اساس شواهد معتبر علمی و ارزیابی تاثیر آن بر خودکارآمدی و عملکرد پرستاران شاغل در بخش های مراقبت ویژه
    1. First, all eligible nurses in the intensive care units of Shahid Sadoughi Hospital are listed. 2. From the listed individuals, 70 individuals are selected by simple random sampling. 3. Then, these 70 individuals are randomly assigned to two groups: the experimental (intervention) and the control (for example, using cards A and B or permutation blocks). 4. After the implementation of the intervention, an evaluation will be conducted.
    The trial will be conducted with blinding and randomization. In phase one, the package design will be carried out. In phase 2, 70 nurses working in intensive care units will be divided into two groups: experimental and control. The randomization function of Excel software will be used for randomization. The intervention will be carried out. Then, the effect of the package will be evaluated.
    1. ابتدا کلیه پرستاران واجد شرایط در بخش‌های مراقبت ویژه بیمارستان شهید صدوقی لیست می‌شوند. 2. از میان افراد لیست شده، ۷۰ نفر به روش تصادفی ساده انتخاب می‌شوند. 3. سپس این ۷۰ نفر با روش تخصیص تصادفی به دو گروه آزمون (مداخله) و کنترل تقسیم می‌شوند. (مثلاً با استفاده از کارت‌های A و B یا بلوک‌های جایگشتی). 4. بعد از اجرای مداخله ذکر شده ارزیابی انجام خواهد پذیرفت.
    کارآزمایی با کورسازی و تصادفی سازی انجام خواهد گرفت. در فاز یک طراحی بسته انجام خواهد گرفت. در فاز 2 ۷۰ پرستار شاغل در بخش های مراقبت ویژه به دو گروه آزمون و کنترل تقسیم خواهند شد. برای تصادفی سازی از عملکرد تصادفی سازی نرم افزار اکسل استفاده خواهد شد. مداخله انجام خواهد گرفت. سپس تاثیر بسته مورد ارزیابی قرار خواهد گرفت.
    The study will be conducted at Shahid Sadoughi Hospital in Yazd. Blinding will be done using three-way blinding and coding.
    In the first phase, the design of the care package was carried out, and in the second phase, the package will be evaluated on nurses working in intensive care units. The study will be conducted at Shahid Sadoughi and Rahnemoon hospitals in Yazd.
    محل انجام مطالعه بیمارستان شهید صدوقی یزد خواهد بود. کورسازی با استفاده از عدم اطلاع سه سویه خواهد بود و با کدبندی انجام خواهد گرفت.
    در فاز اول طراحی بسته ی مراقبتی انجام شده و در فاز دوم ارزیابی بسته بر پرستاران شاغل در بخش های مراقبت ویژه انجام خواهد گرفت. محل انجام مطالعه بیمارستان های شهید صدوقی و رهنمون یزد خواهد بود.
    Inclusion criteria: 1. Resources that directly address tracheostomy care in adults. • Expert panel: 1. Be a member of the university faculty. In the second stage (clinical intervention): 1. Be nurses working in the intensive care units of Shahid Sadoughi Hospital, Yazd. Inclusion criteria: In the first stage (closed design): 1. Be related to the pediatric or neonatal population. In the second stage (clinical intervention): 1. Nurses who are on long-term leave at the time of implementation of the intervention.
    Inclusion criteria: 1. Resources that directly address tracheostomy care in adults. • Expert panel: 1. Be a member of the university faculty. In the second stage: 1. Be nurses working in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd. Exclusion criteria: In the first stage (closed design): 1. Be related to the pediatric or neonatal population. In the second stage (clinical intervention): 1. Nurses who are on leave at the time of implementation of the intervention.
    شرایط ورود: 1. منابعی که مستقیماً به مراقبت از تراکئوستومی در بزرگسالان پرداخته باشند. • پنل خبرگان: 1. عضو هیئت علمی دانشگاه باشند. در مرحله دوم (مداخله بالینی): 1. پرستاران شاغل در بخش‌های مراقبت ویژه بیمارستان شهید صدوقی یزد باشند. شرایط عدم ورود: در مرحله اول (طراحی بسته): 1. مربوط به جمعیت کودکان یا نوزادان باشند. در مرحله دوم (مداخله بالینی): 1. پرستارانی که در زمان اجرای مداخله در مرخصی طولانی‌مدت باشند.
    شرایط ورود: 1. منابعی که مستقیماً به مراقبت از تراکئوستومی در بزرگسالان پرداخته باشند. • پنل خبرگان: 1. عضو هیئت علمی دانشگاه باشند. در مرحله دوم: 1. پرستاران شاغل در بخش‌های مراقبت ویژه بیمارستان های شهید صدوقی و شهید رهنمون یزد باشند. شرایط عدم ورود: در مرحله اول (طراحی بسته): 1. مربوط به جمعیت کودکان یا نوزادان باشند. در مرحله دوم (مداخله بالینی): 1. پرستارانی که در زمان اجرای مداخله در مرخصی باشند.
    The intervention is implemented only for the experimental group: • a) Face-to-face training • b) Providing reminder tools • c) Immediate feedback The control group only performs routine ward care during this period and does not receive any educational intervention.
    The intervention for the experimental group will be: • a) Face-to-face training • b) Providing reminder tools • c) Immediate feedback The control group will not receive any study-related educational intervention during this period.
    مداخله تنها برای گروه آزمون اجرا می‌شود: • الف) آموزش چهره‌به‌چهره • ب) ارائه ابزارهای یادآوری • ج) بازخورد فوری گروه کنترل در این مدت تنها مراقبت‌های معمول بخش را انجام می‌دهند و هیچ مداخله آموزشی دریافت نمی‌کنند.
    مداخله برای گروه آزمون اجرا می‌شود: • الف) آموزش چهره‌به‌چهره • ب) ارائه ابزارهای یادآوری • ج) بازخورد فوری گروه کنترل در این مدت هیچ مداخله آموزشی مرتبط با مطالعه را دریافت نمی‌کنند.
    The outcome of the intervention will be assessed on the self-efficacy and performance of nurses working in intensive care at Shahid Sadoughi Hospital in Yazd in tracheostomy care.
    The outcome of the intervention will be assessed on the self-efficacy and performance of nurses working in Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd in tracheostomy care.
    سنجش نتیجه مداخله بر خودکارآمدی و عملکرد پرستاران شاغل در مراقبت های ویژه بیمارستان شهید صدوقی یزد در مراقبت از تراکئوستومی خواهد بود.
    سنجش نتیجه مداخله بر خودکارآمدی و عملکرد پرستاران شاغل در بیمارستان های شهید صدوقی و شهید رهنمون یزد در مراقبت از تراکئوستومی خواهد بود.
  • General information

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    Increasing the number of sampling environments
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    افزایش تعداد محیط های نمونه گیری
    Designing and evaluating the impact of a "simplified tracheostomy care bundle" on the self-efficacy and performance of nurses working in intensive care units of Shahid Sadoughi Hospital, Yazd in 2026
    Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units
    طراحی و ارزیابی تأثیر "بسته مراقبتی تراکئوستومی ساده‌سازی‌شده" بر خودکارآمدی و عملکرد پرستاران شاغل در بخش های مراقبت ویژه بیمارستان شهید صدوقی یزد در سال 1405
    طراحی و ارزیابی تأثیر "بسته مراقبتی تراکئوستومی ساده‌سازی‌شده" بر خودکارآمدی و عملکرد پرستاران شاغل در بخش های مراقبت ویژه
    Designing and evaluating the impact of a "simplified tracheostomy care bundle" on the self-efficacy and performance of nurses working in intensive care units of Shahid Sadoughi Hospital, Yazd in 2026
    Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units
    طراحی و ارزیابی تأثیر "بسته مراقبتی تراکئوستومی ساده‌سازی‌شده" بر خودکارآمدی و عملکرد پرستاران شاغل در بخش های مراقبت ویژه بیمارستان شهید صدوقی یزد در سال 1405
    طراحی و ارزیابی تأثیر "بسته مراقبتی تراکئوستومی ساده‌سازی‌شده" بر خودکارآمدی و عملکرد پرستاران شاغل در بخش های مراقبت ویژه
    In the first stage (closed design): Textual sources and documents that directly address tracheostomy care in adults in special wards are included in the study.
    They should be clinical guidelines, standard protocols, or original articles/systematic reviews with a high level of evidence.
    Published in Persian or English within the last 5 years (2020 to 2025).
    Their full text is available.
    Expert Panel: Specialists who: have a PhD or Master's degree in nursing (specialization) or specialization in anesthesia or critical care will be included in the study.
    Be a member of the university faculty or have a relevant clinical or educational position.
    Have at least 5 years of useful work experience in intensive care and tracheostomy departments.
    Willingness to participate and sufficient time to review and rate items.
    In the second stage (clinical intervention): Nurses who work in the intensive care units of Shahid Sadoughi Hospital in Yazd will be included in the study.
    Have a bachelor's degree in nursing or higher.
    Have at least 6 months of clinical work experience in the intensive care unit.
    Have written informed consent to participate in the research.
    In the first stage (closed design): Textual sources and documents that directly address tracheostomy care in adults in special wards are included in the study.
    They should be clinical guidelines, standard protocols, or original articles/systematic reviews with a high level of evidence.
    Published in Persian or English within the last 5 years (2020 to 2025).
    Their full text is available.
    Expert Panel: Specialists who: have a PhD or Master's degree in nursing (specialization) or specialization in anesthesia or critical care will be included in the study.
    Be a member of the university faculty or have a relevant clinical or educational position.
    Have at least 5 years of useful work experience in intensive care and tracheostomy departments.
    Willingness to participate and sufficient time to review and rate items.
    In the second stage (clinical intervention): Nurses who work in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd will be included in the study.
    Have a bachelor's degree in nursing or higher.
    Have at least 6 months of clinical work experience in the intensive care unit.
    Have written informed consent to participate in the research.
    در مرحله اول (طراحی بسته): منابع متنی و مدارکی وارد مطالعه می‌شوند که: مستقیماً به مراقبت از تراکئوستومی در بزرگسالان در بخش‌های ویژه پرداخته باشند.
    جزو انواع راهنمای بالینی ، پروتکل استاندارد، یا مقالات اصیل/مروری سیستماتیک با سطح شواهد بالا باشند.
    طی ۵ سال اخیر (۲۰۲۰ تا ۲۰۲۵) به زبان فارسی یا انگلیسی منتشر شده باشند.
    متن کامل آن‌ها در دسترس باشد.
    پنل خبرگان: متخصصانی وارد مطالعه می‌شوند که:دارای مدرک دکتری یا کارشناسی ارشد پرستاری (گرایش ویژه) یا تخصص بیهوشی یا مراقبت‌های ویژه باشند.
    عضو هیئت علمی دانشگاه یا دارای سمت بالینی یاآموزشی مرتبط باشند.
    دارای حداقل ۵ سال سابقه کار مفید در بخش‌های مراقبت ویژه و تراکئوستومی باشند.
    تمایل به مشارکت و زمان کافی برای بررسی و امتیازدهی آیتم‌ها داشته باشند.
    در مرحله دوم (مداخله بالینی):پرستارانی وارد مطالعه می‌شوند که:شاغل در بخش‌های مراقبت ویژه بیمارستان شهید صدوقی یزد باشند.
    دارای مدرک کارشناسی پرستاری یا بالاتر باشند.
    حداقل ۶ ماه سابقه کار بالینی در بخش مراقبت‌های ویژه داشته باشند.
    رضایت آگاهانه کتبی جهت شرکت در پژوهش داشته باشند.
    در مرحله اول (طراحی بسته): منابع متنی و مدارکی وارد مطالعه می‌شوند که: مستقیماً به مراقبت از تراکئوستومی در بزرگسالان در بخش‌های ویژه پرداخته باشند.
    جزو انواع راهنمای بالینی، پروتکل استاندارد، یا مقالات اصیل/مروری سیستماتیک با سطح شواهد بالا باشند.
    طی ۵ سال اخیر (۲۰۲۰ تا ۲۰۲۵) به زبان فارسی یا انگلیسی منتشر شده باشند.
    متن کامل آن‌ها در دسترس باشد.
    پنل خبرگان: متخصصانی وارد مطالعه می‌شوند که: دارای مدرک دکتری یا کارشناسی ارشد پرستاری (گرایش ویژه) یا تخصص بیهوشی یا مراقبت‌های ویژه باشند.
    عضو هیئت علمی دانشگاه یا دارای سمت بالینی یا آموزشی مرتبط باشند.
    دارای حداقل ۵ سال سابقه کار مفید در بخش‌های مراقبت ویژه و تراکئوستومی باشند.
    تمایل به مشارکت و زمان کافی برای بررسی و امتیازدهی آیتم‌ها داشته باشند.
    در مرحله دوم (مداخله بالینی): پرستارانی وارد مطالعه می‌شوند که:شاغل در بخش‌های مراقبت ویژه بیمارستان های شهید صدوقی و شهید رهنمون یزد باشند.
    دارای مدرک کارشناسی پرستاری یا بالاتر باشند.
    حداقل ۶ ماه سابقه کار بالینی در بخش مراقبت‌های ویژه داشته باشند.
    رضایت آگاهانه کتبی جهت شرکت در پژوهش داشته باشند.
    Nurses who are on leave.
    Nurses who are unwilling to participate in the study.
    پرستارانی که در مرخصی باشند.
    پرستارانی که تمایلی به شرکت در مطالعه نداشته باشند.
    First, all eligible nurses in the intensive care units of Shahid Sadoughi Hospital are listed by census method. From the listed individuals, 70 individuals are selected by simple random method (using a random number table or lottery). These 70 individuals are then divided into two groups: test (intervention) and control by random assignment method.
    First, all eligible nurses in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd are listed by census method. From among the listed individuals, 70 individuals are selected by simple random method (using a table of random numbers or lottery). Then, these 70 individuals are divided into two groups: test (intervention) and control by random assignment method.
    ابتدا کلیه پرستاران واجد شرایط در بخش های مراقبت ویژه بیمارستان شهید صدوقی به روش سرشماری لیست می شوند. از میان افراد لیست شده، 70 نفر به روش تصادفی ساده انتخاب می شوند )با استفاده از جدول اعداد تصادفی یا قرعه کشی(. سپس این 70 نفر با روش تخصیص تصادفی به دو گروه آزمون )مداخله( و کنترل تقسیم می شوند.
    ابتدا کلیه پرستاران واجد شرایط در بخش های مراقبت ویژه بیمارستان های شهید صدوقی و شهید رهنمون یزد به روش سرشماری لیست می شوند. از میان افراد لیست شده، 70 نفر به روش تصادفی ساده انتخاب می شوند (با استفاده از جدول اعداد تصادفی یا قرعه کشی). سپس این 70 نفر با روش تخصیص تصادفی به دو گروه آزمون )مداخله( و کنترل تقسیم می شوند.
    .کورسازی با استفاده از عدم اطلاع افراد ذکر شده در مطالعه انجام خواهد پذیرفت
    Blinding will be done in a three-way blind manner. In this way, the participants, researcher, and data analyst will not be aware of the coding and banner division of the control and experimental groups. This means that the nurses will not be aware of the allocation to the control and experimental groups.
    Blinding will be done using the ignorance of the above individuals in the study
    کور سازی بصورت سه سویه کور انجام خواهد گرفت. بدین صورت که شرکت کنندگان و پژوهشگر و آنالیز کننده داده از کدبندی و تقسیم بندی گروه های کنترل و آزمون مطلع نخواهند بود. منظور از تخصیص پرستاران به گروه های کنترل و آزمون مطلع نخواهند بود.
  • Primary outcomes

    #1
    Self-efficacy and performance of nurses working in intensive care units of Shahid Sadoughi Hospital in Yazd in 2016 in tracheostomy care
    Self-efficacy of nurses
    خودکارآمدی و عملکرد پرستاران شاغل در بخش های مراقبت ویژه بیمارستان شهید صدوقی یزد در سال 1405 در مراقبت از تراکئوستومی
    خودکارآمدی پرستاران
    Beginning of the study - after the intervention - two weeks after the intervention
    Beginning of the study, two weeks after the end of the intervention
    ابتدای مطالعه-بعد از مداخله-دو هفته بعد از مداخله
    ابتدای مطالعه، دو هفته بعد از اتمام مداخله
    Tracheostomy Care Questionnaire: To assess the performance of nurses, the Tracheostomy Care Questionnaire will be used. This questionnaire was designed by Kashaninia et al. (8) and was derived from the study by Moussazadeh et al. (28). The self-efficacy scale will be the confidence level questionnaire that was used in the study of Onovah's PhD and in the study of Fatema Abdoltaeb.
    The self-efficacy scale will be the confidence level questionnaire that was used in the study of Onovah's PhD and in the study of Fatema Abdoltaeb.
    پرسشنامه مراقبت از تراکئوستومیبرای بررسی عملکرد پرستاران، از پرسشنامه مراقبت از تراکئوستومی استفاده خواهد شد. این پرسشنامه توسط کاشانی نیا و همکاران (8) که برگرفته از مطالعه موسی‌زاده و همکاران (28) بود، طراحی شده است. مقیاس خودکارآمدی از پرسشنامه ی سطح اطمینان که در پژوهش دکتری اونواوها آورده شده و در مطالعه ی فاطما عبدالتائب استفاده شده است، استفاده خواهد شد.
    مقیاس خودکارآمدی از پرسشنامه ی سطح اطمینان که در پژوهش دکتری اونواوها آورده شده و در مطالعه ی فاطما عبدالتائب استفاده شده است، استفاده خواهد شد.
    #2
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    Performance of nurses
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    عملکرد پرستاران
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    Beginning of the study, two weeks after the end of the intervention
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    ابتدای مطالعه، دو هفته بعد از اتمام مداخله
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    Tracheostomy Care Questionnaire: To assess the performance of nurses, the Tracheostomy Care Questionnaire will be used. This questionnaire was designed by Kashaninia et al. (8) and was derived from the study by Moussazadeh et al. (28).
    empty
    پرسشنامه مراقبت از تراکئوستومی برای بررسی عملکرد پرستاران، از پرسشنامه مراقبت از تراکئوستومی استفاده خواهد شد. این پرسشنامه توسط کاشانی نیا و همکاران (8) که برگرفته از مطالعه موسی‌زاده و همکاران (28) بود، طراحی شده است.
  • Intervention groups

    #1
    Control group: Control group: The intervention is implemented only for the experimental group and includes the following multifaceted strategy:• a) Face-to-face training: Holding small workshops for 45 to 60 minutes in the ward conference room or nursing station. The workshop content includes a brief review of theoretical principles followed by practical exercises on a model or educational equipment based on the "5 Golden Steps of the Care Package".• b) Providing reminder tools:1. Pocket card: Distributing laminated cards in pocket size on which the 5 main actions of the package are printed.2. Wall poster: Installing a graphic and colored poster of the simplified care package algorithm above the heads of tracheostomy patients and in the dirty/clean workroom. C) Immediate feedback: In the first week after training, the researcher will be present in the ward, answer any possible questions, and provide corrective feedback. During this period, the control group will only perform routine ward care and will not receive any educational intervention.
    Control group: Control group: The intervention is implemented only for the experimental group and includes the following multifaceted strategy:• a) Face-to-face training: Holding small workshops for 45 to 60 minutes in the ward conference room or nursing station. The workshop content includes a brief review of theoretical principles followed by practical exercises on a model or educational equipment based on the "5 Golden Steps of the Care Package".• b) Providing reminder tools:1. Pocket card: Distributing laminated cards in pocket size on which the 5 main actions of the package are printed.2. Wall poster: Installing a graphic and colored poster of the simplified care package algorithm above the heads of tracheostomy patients and in the dirty/clean workroom. C) Immediate feedback: In the first week after training, the researcher will be present in the ward, answer any possible questions, and provide corrective feedback.
    گروه کنترل: مداخله تنها برای گروه آزمون اجرا می‌شود و شامل راهبرد چندوجهی زیر است:• الف) آموزش چهره‌به‌چهره: برگزاری کارگاه‌های کوچک به مدت ۴۵ تا ۶۰ دقیقه در اتاق کنفرانس بخش یا ایستگاه پرستاری. محتوای کارگاه شامل مرور مبانی نظری کوتاه و سپس تمرین عملی روی ماکت یا تجهیزات آموزشی بر اساس "۵ گام طلایی بسته مراقبتی" است.• ب) ارائه ابزارهای یادآوری:1. کارت جیبی: توزیع کارت‌های لمینت شده در ابعاد جیبی که ۵ اقدام اصلی بسته روی آن چاپ شده است.2. پوستر دیواری: نصب پوستر گرافیکی و رنگی از الگوریتم ساده‌سازی شده بسته مراقبتی در بالای سر بیماران تراکئوستومی و در اتاق کار کثیف/تمیز.• ج) بازخورد فوری: در هفته اول پس از آموزش، پژوهشگر در بخش حضور یافته و به سوالات احتمالی پاسخ داده و بازخورد اصلاحی ارائه می‌دهد.گروه کنترل در این مدت تنها مراقبت‌های معمول بخش را انجام می‌دهند و هیچ مداخله آموزشی دریافت نمی‌کنند.
    مداخله تنها برای گروه آزمون اجرا می‌شود و شامل راهبرد چندوجهی زیر است:• الف) آموزش چهره‌به‌چهره: برگزاری کارگاه‌های کوچک به مدت ۴۵ تا ۶۰ دقیقه در اتاق کنفرانس بخش یا ایستگاه پرستاری. محتوای کارگاه شامل مرور مبانی نظری کوتاه و سپس تمرین عملی روی ماکت یا تجهیزات آموزشی بر اساس "۵ گام طلایی بسته مراقبتی" است.• ب) ارائه ابزارهای یادآوری:1. کارت جیبی: توزیع کارت‌های لمینت شده در ابعاد جیبی که ۵ اقدام اصلی بسته روی آن چاپ شده است.2. پوستر دیواری: نصب پوستر گرافیکی و رنگی از الگوریتم ساده‌سازی شده بسته مراقبتی در بالای سر بیماران تراکئوستومی و در اتاق کار کثیف/تمیز.• ج) بازخورد فوری: در هفته اول پس از آموزش، پژوهشگر در بخش حضور یافته و به سوالات احتمالی پاسخ داده و بازخورد اصلاحی ارائه می‌دهد.
    #2
    empty
    Other
    empty
    Control group: During this period, the control group only received routine ward care and did not receive any educational intervention.
    empty
    گروه کنترل در این مدت تنها مراقبت‌های معمول بخش را انجام می‌دهند و هیچ مداخله آموزشی دریافت نمی‌کنند.
  • Recruitment centers

    #1
    Name of recruitment center - English: Intensive care units of Shahid Sadoughi Hospital in Yazd
    Name of recruitment center - Persian: بخش های مراقبت ویژه بیمارستان شهید صدوقی یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Street address - English: Yazd Province, Yazd, Shahid Ghandi Boulevard, Ibn Sina Boulevard
    Street address - Persian: استان یزد یزد بلوار شهید قندی، بلوار ابن سینا
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915887857
    Phone: +98 35 3822 9107
    Fax: +98 35 3822 4100
    Email: education@ssu.ac.ir
    Web page address:
    Name of recruitment center - English: Shahid Sadoughi and Shahid Rahnemoon Hospitals in Yazd
    Name of recruitment center - Persian: بیمارستان های شهید صدوقی و شهید رهنمون یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Street address - English: Yazd Province, Yazd, Shahid Ghandi Boulevard, Ibn Sina Boulevard
    Street address - Persian: استان یزد یزد بلوار شهید قندی، بلوار ابن سینا
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915887857
    Phone: +98 35 3822 9107
    Fax: +98 35 3822 4100
    Email: education@ssu.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Shahid Rahnemoon Hospitals in Yazd
    Name of recruitment center - Persian: بیمارستان شهید رهنمون یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Street address - English: Shahid Dr. Rahnamoon Hospital، Farrokhi Yazdi Street، Yazd
    Street address - Persian: یزد - خیابان فرخی یزدی - بیمارستان شهید دکتر رهنمون
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۶۹۷۸۴۷۷
    Phone: +98 35 3724 0171
    Fax: +98 35 3725 4750
    Email: international@ssu.ac.ir
    Web page address:
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Yazd Branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Position - English: Master's student in critical care nursing
    Position - Persian: دانشجوی ارشد پرستاری مراقبت های ویژه
    Latest degree: bachelor
    Area of specialty/work:
    Area of specialty/work title - English: Surgical technologist
    Area of specialty/work title - Persian: تکنولوژیست جراحی
    Street address - English: Sari Land-18 Meter Street-16 Meter Street-No. 21
    Street address - Persian: ساری زمین-خیابان 18 متری-خیابان 16 متری اول- پلاک 21
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5165947663
    Phone: +98 41 3545 0897
    Mobile: +98 914 644 5414
    Fax:
    Email: 1490414241@iau.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Yazd Branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Position - English: Master's student in critical care nursing
    Position - Persian: دانشجوی ارشد پرستاری مراقبت های ویژه
    Latest degree: bachelor
    Area of specialty/work:
    Area of specialty/work title - English: Surgical technologist
    Area of specialty/work title - Persian: تکنولوژیست جراحی
    Street address - English: No. 21، 16 Meter Street، 18 Meter Street، Sari Land
    Street address - Persian: ساری زمین، خیابان 18 متری، خیابان 16 متری اول، پلاک 21
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5165947663
    Phone: +98 41 3545 0897
    Mobile: +98 914 644 5414
    Fax:
    Email: 1490414241@iau.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Yazd Branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Position - English: Master's student in critical care nursing
    Position - Persian: دانشجوی ارشد پرستاری مراقبت های ویژه
    Latest degree: bachelor
    Area of specialty/work:
    Area of specialty/work title - English: Surgical technologist
    Area of specialty/work title - Persian: تکنولوژیست جراحی
    Street address - English: Sari Land-18 Meter Street-16 Meter Street First-No. 21
    Street address - Persian: ساری زمین-خیابان 18 متری-خیابان 16 متری اول-پلاک 21
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5165947663
    Phone: +98 41 3545 0897
    Mobile: +98 914 644 5414
    Fax:
    Email: 149041241@iau.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Yazd Branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Position - English: Master's student in critical care nursing
    Position - Persian: دانشجوی ارشد پرستاری مراقبت های ویژه
    Latest degree: bachelor
    Area of specialty/work:
    Area of specialty/work title - English: Surgical technologist
    Area of specialty/work title - Persian: تکنولوژیست جراحی
    Street address - English: No. 21، 16 Meter Street، 18 Meter Street، Sari Land
    Street address - Persian: ساری زمین، خیابان 18 متری، خیابان 16 متری اول، پلاک 21
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5165947663
    Phone: +98 41 3545 0897
    Mobile: +98 914 644 5414
    Fax:
    Email: 149041241@iau.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Yazd Branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Position - English: Master's student in critical care nursing
    Position - Persian: دانشجوی ارشد پرستاری مراقبت های ویژه
    Latest degree: bachelor
    Area of specialty/work:
    Area of specialty/work title - English: Surgical technologist
    Area of specialty/work title - Persian: تکنولوژیست جراحی
    Street address - English: Sari Land-18 Meter Street-16 Meter Street First-No. 21
    Street address - Persian: ساری زمین-خیابان 18 متری-خیابان 16 متری اول-پلاک 21
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5165947663
    Phone: +98 41 3545 0897
    Mobile: +98 914 644 5414
    Fax:
    Email: 1490414241@iau.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Yazd Branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد یزد
    Full name of responsible person - English: Amir farsiou
    Full name of responsible person - Persian: امیر فرسیو
    Position - English: Master's student in critical care nursing
    Position - Persian: دانشجوی ارشد پرستاری مراقبت های ویژه
    Latest degree: bachelor
    Area of specialty/work:
    Area of specialty/work title - English: Surgical technologist
    Area of specialty/work title - Persian: تکنولوژیست جراحی
    Street address - English: No. 21، 16 Meter Street، 18 Meter Street، Sari Land
    Street address - Persian: ساری زمین، خیابان 18 متری، خیابان 16 متری اول، پلاک 21
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5165947663
    Phone: +98 41 3545 0897
    Mobile: +98 914 644 5414
    Fax:
    Email: 1490414241@iau.ir
    Web page address:

Protocol summary

Study aim
Designing and developing a simplified tracheostomy care package based on valid scientific evidence and evaluating its impact on the self-efficacy and performance of nurses working in intensive care unit
Design
The trial will be conducted with blinding and randomization. In phase one, the package design will be carried out. In phase 2, 70 nurses working in intensive care units will be divided into two groups: experimental and control. The randomization function of Excel software will be used for randomization. The intervention will be carried out. Then, the effect of the package will be evaluated.
Settings and conduct
In the first phase, the design of the care package was carried out, and in the second phase, the package will be evaluated on nurses working in intensive care units. The study will be conducted at Shahid Sadoughi and Rahnemoon hospitals in Yazd.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Resources that directly address tracheostomy care in adults. • Expert panel: 1. Be a member of the university faculty. In the second stage: 1. Be nurses working in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd. Exclusion criteria: In the first stage (closed design): 1. Be related to the pediatric or neonatal population. In the second stage (clinical intervention): 1. Nurses who are on leave at the time of implementation of the intervention.
Intervention groups
The intervention for the experimental group will be: • a) Face-to-face training • b) Providing reminder tools • c) Immediate feedback The control group will not receive any study-related educational intervention during this period.
Main outcome variables
The outcome of the intervention will be assessed on the self-efficacy and performance of nurses working in Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd in tracheostomy care.

General information

Reason for update
Increasing the number of sampling environments
Acronym
IRCT registration information
IRCT registration number: IRCT20260226068953N1
Registration date: 2026-05-17, 1405/02/27
Registration timing: prospective

Last update: 2026-06-23, 1405/04/02
Update count: 1
Registration date
2026-05-17, 1405/02/27
Registrant information
Name
Amir Farsiou
Name of organization / entity
Islamic Azad University of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 41 3545 0897
Email address
amir.farsiou1395@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units
Public title
Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
In the first stage (closed design): Textual sources and documents that directly address tracheostomy care in adults in special wards are included in the study. They should be clinical guidelines, standard protocols, or original articles/systematic reviews with a high level of evidence. Published in Persian or English within the last 5 years (2020 to 2025). Their full text is available. Expert Panel: Specialists who: have a PhD or Master's degree in nursing (specialization) or specialization in anesthesia or critical care will be included in the study. Be a member of the university faculty or have a relevant clinical or educational position. Have at least 5 years of useful work experience in intensive care and tracheostomy departments. Willingness to participate and sufficient time to review and rate items. In the second stage (clinical intervention): Nurses who work in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd will be included in the study. Have a bachelor's degree in nursing or higher. Have at least 6 months of clinical work experience in the intensive care unit. Have written informed consent to participate in the research.
Exclusion criteria:
Nurses who are on leave. Nurses who are unwilling to participate in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
First, all eligible nurses in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd are listed by census method. From among the listed individuals, 70 individuals are selected by simple random method (using a table of random numbers or lottery). Then, these 70 individuals are divided into two groups: test (intervention) and control by random assignment method.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding will be done in a three-way blind manner. In this way, the participants, researcher, and data analyst will not be aware of the coding and banner division of the control and experimental groups. This means that the nurses will not be aware of the allocation to the control and experimental groups.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
research Ethics committees of islamic azad University - isfahan (khorasgan) branch
Street address
Isfahan - East Jay Street - Arghavanieh - Daneshgah Boulevard - Islamic Azad University of Isfahan Branch (Khorasgan)
City
khorasgan
Province
Isfehan
Postal code
8155139998
Approval date
2026-04-12, 1405/01/23
Ethics committee reference number
IR.IAU.KHUISF.REC.1405.016

Health conditions studied

1

Description of health condition studied
Tracheostomy care
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-efficacy of nurses
Timepoint
Beginning of the study, two weeks after the end of the intervention
Method of measurement
The self-efficacy scale will be the confidence level questionnaire that was used in the study of Onovah's PhD and in the study of Fatema Abdoltaeb.

2

Description
Performance of nurses
Timepoint
Beginning of the study, two weeks after the end of the intervention
Method of measurement
Tracheostomy Care Questionnaire: To assess the performance of nurses, the Tracheostomy Care Questionnaire will be used. This questionnaire was designed by Kashaninia et al. (8) and was derived from the study by Moussazadeh et al. (28).

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Control group: The intervention is implemented only for the experimental group and includes the following multifaceted strategy:• a) Face-to-face training: Holding small workshops for 45 to 60 minutes in the ward conference room or nursing station. The workshop content includes a brief review of theoretical principles followed by practical exercises on a model or educational equipment based on the "5 Golden Steps of the Care Package".• b) Providing reminder tools:1. Pocket card: Distributing laminated cards in pocket size on which the 5 main actions of the package are printed.2. Wall poster: Installing a graphic and colored poster of the simplified care package algorithm above the heads of tracheostomy patients and in the dirty/clean workroom. C) Immediate feedback: In the first week after training, the researcher will be present in the ward, answer any possible questions, and provide corrective feedback.
Category
Other

2

Description
Control group: During this period, the control group only received routine ward care and did not receive any educational intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi and Shahid Rahnemoon Hospitals in Yazd
Full name of responsible person
Amir farsiou
Street address
Yazd Province, Yazd, Shahid Ghandi Boulevard, Ibn Sina Boulevard
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 9107
Fax
+98 35 3822 4100
Email
education@ssu.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Rahnemoon Hospitals in Yazd
Full name of responsible person
Amir farsiou
Street address
Shahid Dr. Rahnamoon Hospital، Farrokhi Yazdi Street، Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Fax
+98 35 3725 4750
Email
international@ssu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Yazd Branch
Full name of responsible person
Amir farsiou
Street address
Yazd, Safaiyeh, Alam Square, Unknown Shohada Blvd., Islamic Azad University Complex
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 6781
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Yazd Branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Yazd Branch
Full name of responsible person
Amir farsiou
Position
Master's student in critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
No. 21، 16 Meter Street، 18 Meter Street، Sari Land
City
Tabriz
Province
East Azarbaijan
Postal code
5165947663
Phone
+98 41 3545 0897
Email
1490414241@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Yazd Branch
Full name of responsible person
Amir farsiou
Position
Master's student in critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
No. 21، 16 Meter Street، 18 Meter Street، Sari Land
City
Tabriz
Province
East Azarbaijan
Postal code
5165947663
Phone
+98 41 3545 0897
Email
149041241@iau.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Yazd Branch
Full name of responsible person
Amir farsiou
Position
Master's student in critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
No. 21، 16 Meter Street، 18 Meter Street، Sari Land
City
Tabriz
Province
East Azarbaijan
Postal code
5165947663
Phone
+98 41 3545 0897
Email
1490414241@iau.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be published publicly and confidentially to help advance education.
When the data will become available and for how long
After completing data analysis
To whom data/document is available
Researchers, investigators, and individuals involved in the clinical care of tracheostomy patients.
Under which criteria data/document could be used
In order to protect patient privacy and advance scientific insights
From where data/document is obtainable
To the journal that will publish the study results.
What processes are involved for a request to access data/document
The requester can access the data by obtaining permission from the researcher, protecting patient privacy, and by referring to journals.
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