Protocol summary

Study aim
Investigating the effect of narrative writing on job stress of nurses working in intensive care units
Design
Clinical trial with control group, with parallel groups, without blinding, randomized on 66 nurses. Minimization software will be used for randomization.
Settings and conduct
This study will be performed on nurses working in the general intensive care units of Al-Zahra, Khorshid, Kashani and Amin hospitals in Isfahan. First, job stress of control group nurses will be measured at the beginning of the study and one month and two months later. Then, job stress of nurses in the test group will be measured before the intervention and one month and two months later.
Participants/Inclusion and exclusion criteria
Nurses who have at least a bachelor's degree in nursing, have worked in the ICU for at least the last 6 months, do not have managerial roles, and do not have psychiatric disorders.
Intervention groups
First, the level of job stress of nurses in the control group will be assessed at the beginning and after one month and two months later with an expanded questionnaire of the Nursing Stress Scale. The test group then fills out a questionnaire. The test group will then be taught the correct method of narrative writing and a white booklet will be given to the test group to express their feelings in this booklet and at home, at least once a week for 15 to 30 minutes each time for a month. Then, the level of job stress of the nurses in the experimental group will be reviewed again after one month and two months later. In order to the control group benefit from the research , all interventions that have been done for the experimental group will be done in the same way for the control group after the end of the study.
Main outcome variables
Stress score in Expanded Nursing Stress Scale (ENSS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211207053324N1
Registration date: 2022-01-11, 1400/10/21
Registration timing: prospective

Last update: 2022-01-11, 1400/10/21
Update count: 0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
marzieh sadat jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3557 1320
Email address
jafari1991@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of narrative writing on job stress of nurses working in intensive care units
Public title
Investigating the effect of narrative writing on job stress of nurses in intensive units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses who have at least a bachelor's degree in nursing Nurses who have been working in the ICU for at least the last 6 months
Exclusion criteria:
Nurses who have managerial roles Nurses who have experienced traumatic stress in the last 6 months Nurses with psychological disorders Nurses under psychiatric treatment Nurses who have used medication related to psychiatric disorders in the past 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are randomly divided into two groups of test and control using minimization software. The minimization software divides the samples into groups in such a way that there is at least a difference between them. Variables to be included in the software include age, gender, marital status, pregnancy, number of children, home care for the elderly, level of education, employment status, shift work, number of night shifts per month, number of shifts during the holidays, nurse ratio To the patient, Work experience, ICU work experience, employment in another hospital, overtime hours, history of chronic illness, job interest, body mass index and income level.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Nursing, Rehabilitation and Management schools- Isfahan University of m
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Headquarters
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.170

Health conditions studied

1

Description of health condition studied
Nurses' job stress
ICD-10 code
R46.6
ICD-10 code description
Undue concern and preoccupation with stressful events

Primary outcomes

1

Description
Stress score in Expanded Nursing Stress Scale (ENSS)
Timepoint
At the beginning of the study and 1 and 2 months after the start of the study
Method of measurement
Expanded Nursing Stress Scale (ENSS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group first fills out the expanded Nursing Stress Scale questionnaire. After that, this group will be taught the correct method of narrative writing by holding a continuing education program called "Narrative Writing Webinar". In this webinar, various hypothetical scenarios of stressful conditions for nurses working in intensive care units are presented. The first scenario shows the example of narrative writing in practice and in the next scenarios, the intervention group practices narrative writing. The researcher then provides the intervention group with a white notebook and asks them to write down their feelings in this notebook at home, in a secluded room. In the first few pages of this notebook, guidance for narrative writing is provided. This guide includes job stress definition, narrative writing definition, narrative writing instructions, and examples of this type of writing. At least once a week for a month, 15 to 30 minutes at a time, people freely express their feelings about the deepest stressful experiences, the most difficult moments and behaviors in the intensive care unit. after one month, they deliver the notebook to the researcher. Individuals are reassured that only the pages of the notebook will be seen at the time of delivery and the notebook will be returned to them without reading the content. Immediately after the intervention and one month later, the expanded Nursing Stress Scale questionnaire will be completed by the intervention group Again.
Category
Behavior

2

Description
Control group: Using the expanded questionnaire of the Nursing Stress Scale, the level of job stress of nurses in the control group is assessed at the beginning of the study and after one month and two months later. In order to the control group benefit from the research after the study, the webinar on narrative writing for the control group is also conducted.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mehrdad Norouzi
Street address
Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

2

Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Hamid Melali
Street address
Ebne Sina Street
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Fax
+98 31 3445 9002
Email
amin@mui.ac.ir
Web page address
https://amin.mui.ac.ir/

3

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Saeed Majidi Nejad
Street address
Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Fax
+98 31 3233 5030
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir/

4

Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Ramin Sami
Street address
Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Fax
+98 31 3222 2255
Email
nour@mui.ac.ir
Web page address
https://nour.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh sadat Jafari
Position
Masters’ student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Negin Alley, Meraj street, Parvin street
City
Isfahan
Province
Isfehan
Postal code
8168693163
Phone
+98 31 3557 1320
Fax
Email
jafari1991@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh sadat Jafari
Position
Masters’ student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Negin Alley, Meraj street, Parvin street
City
Isfahan
Province
Isfehan
Postal code
8168693163
Phone
+98 31 3557 1320
Fax
Email
jafari1991@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh sadat Jafari
Position
Masters’ student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Negin Alley, Meraj street, Parvin street
City
Isfahan
Province
Isfehan
Postal code
8168693163
Phone
+98 31 3557 1320
Fax
Email
jafari1991@nm.mui.ac.ir

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
اطلاعات بیشتری وجود ندارد
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutes are allowed to access the mentioned information
Under which criteria data/document could be used
The methodology and questionnaires used are provided to other researchers for use
From where data/document is obtainable
Applicants can send me an email to receive the required documents or data. Email Address: jafari1991@nm.mui.ac.ir
What processes are involved for a request to access data/document
One week after the data request, the required information will be emailed to the researchers
Comments
The narrations and the informed consent form will remain confidential.
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