Protocol summary

Study aim
Determining the effect of care plan application based on standardized nursing language on nurses' attitude to utilization of standardized nursing language and the quality of documentation of nursing diagnoses, interventions, and outcomes
Design
Quasi-experimental, single-blind study with two groups in a pretest–posttest design will be conducted, using a census sampling method. Considering an anticipated attrition rate of 15%, the final sample size will be set at 40 participants per group.
Settings and conduct
The study will be conducted in the units of the cardiology department at Imam Reza Hospital. The intervention will consist of using the mobile application containing standardized nursing care plans for four weeks. Data will be collected before and after the intervention using questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nurses with at least a bachelor's degree, Full-time employment in one of the units of the cardiology department, A minimum of two months of clinical experience in the cardiology department, Willingness to participate in the study Exclusion criteria: Change of workplace, Unwillingness to participate or to continue the intervention, Using the application for less than 120 minutes (approximately 30 minutes per week)
Intervention groups
Intervention group will consist of nurses from the CCU1, CCU2, and Post-CCU1 units of Imam Reza Hospital. These nurses will receive the educational intervention, and the care-plan application will be installed for them. Control group will comprise nurses from the CCU3, CCU4, and Post-CCU2 units of Imam Reza Hospital. They will not receive any additional educational intervention and will continue to follow the hospital’s routine program.
Main outcome variables
attitude to utilization of standardized nursing language and the quality of documentation of nursing diagnoses, interventions, and outcomes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250926067364N1
Registration date: 2025-11-25, 1404/09/04
Registration timing: registered_while_recruiting

Last update: 2025-11-25, 1404/09/04
Update count: 0
Registration date
2025-11-25, 1404/09/04
Registrant information
Name
Mohammad Sheikhi Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3522 8206
Email address
sheikhiam4021@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-06-22, 1405/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care plan application based on standardized nursing language on nurses' attitude to utilization of standardized nursing language and the quality of documentation of nursing diagnoses, interventions, and outcomes
Public title
The effect of care plan application based on standardized nursing language on nurses' attitude to utilization of standardized nursing language and the quality of documentation of nursing diagnoses, interventions, and outcomes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses with at least a bachelor's degree Full-time employment in one of the units of the cardiology department At least two months of clinical experience in the cardiology department Willingness to participate in the study
Exclusion criteria:
Change of workplace Unwillingness to participate or to continue the intervention Using the application for less than 120 minutes (approximately 30 minutes per week) during the intervention period
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the individual evaluating the outcomes will be unaware of which participants belong to the intervention group or the control group. Information concerning the quality of documented nursing diagnoses, interventions, and outcomes will be coded and sent to the evaluator without any identifying group information. The evaluator will exclusively access anonymized data and will remain ignorant of the group associations of the data. This method is employed to reduce the potential for bias in evaluating outcomes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of the faculty of Nursing and Midwifery - Mashhad University of Medical Sc
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2025-11-04, 1404/08/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1404.081

Health conditions studied

1

Description of health condition studied
Cardiovascular System
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Attitude
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Nurses' attitude to utilization of standardized nursing language questionnaire

2

Description
Quality of documentation
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Quality of recording diagnoses, interventions, and nursing outcomes questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: consists of the nurses from the CCU1, CCU2, and Post-CCU1 units of the Cardiology Department at Imam Reza Hospital, who will receive the educational intervention. The care plan application will be installed for them, and for a period of four weeks, they will record their reports based on the standardized patient care plan. During this period, head nurses and shift supervisors will provide necessary feedback on their nursing reports using guidance tools. Data collection will be conducted from them before and after the intervention.
Category
Behavior

2

Description
Control group: The control group consists of nurses from the CCU3, CCU4, and Post-CCU2 units of the Cardiology Department at Imam Reza Hospital. They will not receive any additional educational intervention and will only follow the hospital’s usual program in this regard. Data collection will be conducted for this group before and after the intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Salaman Soltani
Street address
Imam Reza Educational, Research and Treatment Center, Ibn Sina St, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Imamreza@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, Shahid Dr. Kharazmi Educational Complex - Fourth Floor, East Gate of Ferdowsi University of Mashhad, University Campus, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Sheikhi Azizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 64, Shariati Ave, Shariati Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177943707
Phone
+98 51 3522 8206
Fax
Email
Sheikhiam4021@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Heshmati nabavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6732
Email
heshmatinf@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Sheikhi Azizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 64, Shariati Ave, Shariati Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177943707
Phone
+98 51 3522 8206
Fax
Email
sheikhiam4021@mums.ac.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Things that explain the results of our intervention and limitations
When the data will become available and for how long
Access period starts: 6 months after publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Scientific research to help the nursing community
From where data/document is obtainable
Researchers' email
What processes are involved for a request to access data/document
One month
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