Protocol summary

Study aim
Determining the effect of the wound care training program on nurses' wound care self-efficacy
Design
Study Type: Randomized, triple-blind, parallel-group controlled clinical trial Intervention Group: Receives the wound care training workshop. Control Group: Does not receive the training workshop. Randomization Method: Using a black bag containing the names of participants. Sample Size: Based on 80% power and 95% confidence level, each group will have approximately 30 participants, totaling around 60 participants. Phases of the Trial: Pre-Trial: Collect baseline data and perform randomization. Intervention: Conduct the educational program. Post-Trial: Complete questionnaires and analyze data
Settings and conduct
obtaining approvals, sampling and allocation, six 1.5-hour training sessions over a month (space limited)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a bachelor's degree in nursing Consent to participate in the study Failure to participate in previous wound courses Non-entry conditions and exclusion criteria: Participation in concurrent wound care courses being a student Lack of consent to participate in the study
Intervention groups
The intervention will be conducted as a workshop by the researcher for the intervention group in 6 sessions based on the specified content. The educational content will be prepared and approved by specialists and experts. Schedule and Course of Educational Sessions: Anatomy and Physiology of the Skin Definition and Classification of Wounds Prevention Methods Stages of Wound Care and Treatment Modern Wound Treatment Methods (1) Modern Wound Treatment Methods (2). Each of the 6 sessions above will be held in-person using slides, models, and videos for 1.5 hours; follow-up to consolidate learning and answer questions will be conducted in Rubika throughout the intervention month.
Main outcome variables
wound care self-effecacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240708062361N1
Registration date: 2024-08-16, 1403/05/26
Registration timing: retrospective

Last update: 2024-08-16, 1403/05/26
Update count: 0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Ghasem Hajilo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 553 0678
Email address
ghasemhajilo18@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2024-08-15, 1403/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention on wound care self-efficacy in nurses
Public title
the effect of educational intervention on wound care self-efficacy in nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Having a bachelor's degree in nursing 2- Having consent to participate in the study 3- Not participating in previous wound courses
Exclusion criteria:
Not participating in two training sessions and wanting to leave the study
Age
From 22 years old to 60 years old
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method and Explanation Simple Randomization A simple randomization method will be chosen. In this method, all participants will have an equal chance of being assigned to either the intervention or control group. Unit of Randomization The unit of randomization will be individual, meaning that each participant will be independently and separately assigned to either the intervention or control group. Random Sequence Generation To generate the random sequence, the names of the participants will be written on equally-sized slips of paper and placed in a black bag. The slips will then be drawn from the bag in sequence, and participants will be assigned to the intervention and control groups alternately. This process will be without replacement, meaning that once a name is drawn from the bag, it will not be returned to the bag. Allocation Concealment To ensure allocation concealment and prevent bias, the assignment of participants to groups will remain unknown to the researchers until the moment the slip is drawn from the bag. This method will ensure that the researchers cannot influence the decision-making process before allocation, and assignments will be made in a completely random and unbiased manner.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, to reduce bias and enhance the accuracy of the results, precise blinding methods will be used. The following outlines who and how individuals will be blinded in the study: Participants Participants will be informed that they are part of a scientific study, but they will not be informed of the specific details of the intervention (whether they are in the intervention or control group). This will be achieved by providing only general information about the type of education they will receive, without disclosing their group assignment. Principal Investigator The principal investigator responsible for designing and conducting the study will remain unaware of the participants' group assignments until the data collection is completed. This will be ensured by having an independent person handle the randomization and allocation process. Healthcare Personnel Healthcare personnel (including doctors, nurses, physiotherapists, etc.) responsible for the care of the participants will be blinded to the group assignments. These personnel will follow standard protocols and will not have information regarding the group assignments of the participants. Data Collectors Individuals responsible for data collection will be blinded to the participants' group assignments. Data will be collected blindly and without knowledge of the group assignments. Outcome Assessors Individuals responsible for assessing the study outcomes will be blinded to the participants' group assignments. Assessments will be made based on the collected data without considering the group assignments. Data Safety and Monitoring Committee (DSMC) The Data Safety and Monitoring Committee will be blinded to the group assignments unless safety reasons necessitate disclosure. This committee will monitor the progress of the study and ensure the safety of the participants. Manuscript Writers Individuals responsible for drafting the manuscript will remain blinded to the group assignments until the final data analysis and code breaking. Data analysis will be conducted blindly, and the final results will be revealed only after the codes are opened. These procedures are implemented to ensure precise blinding and minimize the risk of bias in the study results.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatullah University of Medical Sciences (AS)
Street address
Tehran, Mollasadra Street, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2024-07-26, 1403/05/05
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.084

Health conditions studied

1

Description of health condition studied
Diabetic ulcers, pressure ulcers and other postoperative wounds
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Wound care self-efficacy
Timepoint
the beginning of the study and 30 days after the start of the study or immediately after the end of the intervention
Method of measurement
Wound care self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention will be conducted as a workshop by the researcher for the intervention group in 6 sessions based on the specified content. The educational content will be prepared and approved by specialists and experts.Schedule and Course of Educational Sessions:Anatomy and Physiology of the Skin: Examination of the structure and function of the skin, its relationship with wounds, and its impact on wound healing and care.Definition and Classification of Wounds: Introduction and explanation of types of wounds, including pressure ulcers, vascular wounds, diabetic wounds, and traumatic wounds, with examples.Prevention Methods: Examination of methods to prevent wounds, principles of maintaining healthy skin, and preventing complications related to wounds.Stages of Wound Care and Treatment: Explanation of stages of wound care and treatment, including cleaning wounds, using dressings, changing dressings, infection control, and methods to expedite wound healing.Modern Wound Treatment Methods (1): Introduction and review of modern wound treatment methods, including skin regeneration therapies and the use of advanced technologies.Modern Wound Treatment Methods (2): Continuation of the introduction and review of modern wound treatment methods, including skin regeneration therapies and the use of advanced technologies.Each of the 6 sessions above will be held in-person using slides, models, and videos for 1.5 hours; follow-up to consolidate learning and answer questions will be conducted in Rubika throughout the intervention month.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatullah Hospital in Tehran
Full name of responsible person
Mehdi Jafarioori
Street address
Unit 2, No. 22, Sepehr Alley, Shahid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1155766314
Phone
+98 914 197 3745
Email
m.jafarioori@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
دکتر ایمان فولادی
Street address
Tehran, Mollasadra Street, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5501
Email
F_F_1346@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gasem Hajilo
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Mollasadra Street, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5501
Email
ghasemhajilo18@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mehdi JafariOori
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Please translate this address into English: Unit 2, No. 22, Sepehr Alley, Shahid Square, Tehran.
City
Tehran
Province
Tehran
Postal code
1155766314
Phone
+98 21 8755 5501
Email
m.jafarioori@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gasem Hajilo
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Mollasadra Street, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5501
Email
ghasemhajilo18@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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