Protocol summary

Study aim
1-Determining and comparing the mean score of the stigmatizing attitudes of nursing students in two intervention and control groups before and after the implementation of interventions based on cognitive strategies. 2-Determining and comparing the mean score of nursing students' stigmatizing attitudes between two intervention and control groups before and after the implementation of interventions based on cognitive strategies.
Design
The clinical trial has two intervention and control groups with parallel, randomized groups
Settings and conduct
Nursing students of the Faculty of Nursing and Midwifery, Faculty of Nursing,Urmia University of Medical Sciences in the academic year 1400-1401, samples are randomly selected and meetings are held.
Participants/Inclusion and exclusion criteria
inclusion criteria: Consent to participate in the research - Not participating in the previous similar research - Studying in the field of nursing in the first and second semesters in the academic year of 1401. Exclusion criteria: absence in at least one third of the training sessions
Intervention groups
In the intervention group, intervention in person and online, according to the conditions of the intervention time and in the form of interventions based on cognitive strategies for 10 sessions and twice a week for the samples of the intervention group (3 groups of 10 people), along with 3 sessions of supplementary discussions With 3 rounds of pre-test measurement, it will be immediately after and 3 months later. In the control group, 3 times of measurement are done without a training class.
Main outcome variables
Stigmatic attitude

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161227031588N4
Registration date: 2022-08-02, 1401/05/11
Registration timing: prospective

Last update: 2022-08-02, 1401/05/11
Update count: 0
Registration date
2022-08-02, 1401/05/11
Registrant information
Name
Haleh Ghavami
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4962
Email address
ghavami.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalution of Cognitive Strategic Based Interventions on Nursing Students' Stigmatizing Attitudes toward Patients with Mental Disorders
Public title
Evalution of Cognitive Strategic Based Interventions on Nursing Students' Stigmatizing Attitudes toward Patients with Mental Disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
رضایت به حضور در پژوهش Not participating in a previous similar study studing nursing in the first and second semesters in the academic year of 1401
Exclusion criteria:
Absence in at least one third of training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization in this study, an independent researcher made random allocation cards using computer generated the random numbers. The allocator kept the original random allocation sequences in an inaccessible third place and worked with a copy. Instead of the letters A and B, she used the codes E and C (E for experimental group and C for control group) to avoid further confusion. Then, she continued to randomize until the intervention and control group samples were completed.
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
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714838791
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.UMSU.REC.1400.104

Health conditions studied

1

Description of health condition studied
Stigmatizing behaviors
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stigmatic attitudes
Timepoint
Before and after intervention
Method of measurement
Demographic Information Questionnaire - Stigmatistic Attitudes Questionnaire AQ27

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention program will be implemented face-to-face and online, according to the conditions of the intervention time and in the form of interventions based on cognitive strategies for 10 sessions and twice a week for the samples of the intervention group (3 groups of 10 people) by the researcher. These sessions are not limited to education, at the end of each session there will be discussion and exchange of opinions between the students. In sessions 7 to 9, the intervention group in the psychiatry department of Razi Hospital will meet and have direct contact with hospitalized patients, and in this regard, additional discussions will be held with the intervention group at the end of these 3 sessions. will have. The pre-test and post-test will be done immediately (and three months after the end of the intervention) using the mental illness stigma scale AQ27 in both the intervention and control groups.Community Verified icon
Category
Behavior

2

Description
Control group: An introduction meeting will be held and during this introduction meeting the objectives of the research will be explained and then the AQ27 questionnaire will be provided to them and after the completion of the research intervention, the AQ27 questionnaire will be administered 2 times immediately and 3 months after the intervention of the intervention group. The control will be completed.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nursing and Midwifery, Faculty of Nursing, Urmia University of Medical Sciences
Full name of responsible person
Somayeh shamsozoha
Street address
Urmia, Modarres Boulevard,Ershad Boulevard,Imam Khomeini Hospital
City
urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 914 147 5234
Email
shamsalzoha.s@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Resalat Blvd,Orjhans Alley
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Email
zabgarm@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Oroumia University of Medical Sciences
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou,11 km of Nazlou Road,Urmia,Iran
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 4962 3275
Email
haleh_ghavami@yahoo.co.uk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Haleh Ghavami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4962
Fax
Email
haleh_ghavami@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Haleh Ghavami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
Email
haleh_ghavami@yahoo.co.uk
Web page address

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
No - There is not 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
En Participants' personal data can be shared after Unrecognizable
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Researchers working in academic and scientific centers
Under which criteria data/document could be used
Use of documentation in research
From where data/document is obtainable
shamsalzoha.s@umsu.ac.ir
What processes are involved for a request to access data/document
shamsalzoha.s@umsu.ac.ir
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