Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Increasing the number of sampling environments
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Acronym
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IRCT registration information
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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
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Registration date
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2026-05-17, 1405/02/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-05-22, 1405/03/01
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Expected recruitment end date
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2026-09-22, 1405/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units
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Public title
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Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-04-12, 1405/01/23
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Ethics committee reference number
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IR.IAU.KHUISF.REC.1405.016
Health conditions studied
1
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Description of health condition studied
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Tracheostomy care
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Self-efficacy of nurses
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Timepoint
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Beginning of the study, two weeks after the end of the intervention
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Method of measurement
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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
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Description
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Performance of nurses
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Timepoint
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Beginning of the study, two weeks after the end of the intervention
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Method of measurement
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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).
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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Control group: During this period, the control group only received routine ward care and did not receive any educational intervention.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University, Yazd Branch
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The data will be published publicly and confidentially to help advance education.
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When the data will become available and for how long
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After completing data analysis
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To whom data/document is available
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Researchers, investigators, and individuals involved in the clinical care of tracheostomy patients.
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Under which criteria data/document could be used
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In order to protect patient privacy and advance scientific insights
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From where data/document is obtainable
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To the journal that will publish the study results.
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What processes are involved for a request to access data/document
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The requester can access the data by obtaining permission from the researcher, protecting patient privacy, and by referring to journals.
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Comments
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