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
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.
Design
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.
Settings and conduct
The study will be conducted at Shahid Sadoughi Hospital in Yazd. Blinding will be done using three-way blinding and coding.
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 (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.
Intervention groups
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.
Main outcome variables
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.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260226068953N1
Registration date:2026-05-17, 1405/02/27
Registration timing:prospective
Last update:2026-05-17, 1405/02/27
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 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
Public title
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
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 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.
Exclusion criteria:
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 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.
Blinding (investigator's opinion)
Triple blinded
Blinding description
.کورسازی با استفاده از عدم اطلاع افراد ذکر شده در مطالعه انجام خواهد پذیرفت
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 and performance of nurses working in intensive care units of Shahid Sadoughi Hospital in Yazd in 2016 in tracheostomy care
Timepoint
Beginning of the study - after the intervention - two weeks after 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). 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.
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. During this period, the control group will only perform routine ward care and will not receive any educational intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care units of Shahid Sadoughi Hospital 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
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
Sari Land-18 Meter Street-16 Meter Street-No. 21
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
Sari Land-18 Meter Street-16 Meter Street First-No. 21
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
Sari Land-18 Meter Street-16 Meter Street First-No. 21
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.