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Effect of education based on self-regulation education on reducing the anxiety of second-year high school students

Protocol summary

Study aim
Effect of Education Based on Self-Regulatory Theory on Reducing Anxiety in Secondary School Students in Mashhad, 1396
Design
This is a semi-experimental study. The statistical population of this study is female secondary school students. Sample size was calculated using the mean and standard deviation of the self-regulating variable (according to the formula) of 57 individuals in each group, with a probability estimated of 60 people, which included 120 people. The sampling method was done in a cluster fashion. , So that from 7 education districts of Mashhad a randomly selected area is selected and from high school schools covered by the above two state schools are selected and samples are collected
Settings and conduct
This intervention was conducted in Mashhad
Participants/Inclusion and exclusion criteria
The criteria for entering this study include the desire to participate in the study, high school students, female gender, lack of records of mental illnesses and residents of Mashhad. Exit criteria include, reluctance to continue cooperation, absence of maximum two educational sessions, non-compliance Accountability is more than 10% to questionnaire questions
Intervention groups
The control group does not receive any educational intervention, but in the experimental group, educational intervention based on self-regulation theory aims to improve mental health and reduce anxiety in secondary school students. Mean scores of mental health, anxiety and self-regulation learning strategies before, immediately and three months after intervention were measured and compared by a questionnaire in two groups of test and control
Main outcome variables
Measurement of the scores of mental health questionnaire, anxiety and self-regulation learning strategies before, immediately and three months after the intervention in the target group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160710028863N31
Registration date: 2018-07-30, 1397/05/08
Registration timing: retrospective

Last update: 2018-07-30, 1397/05/08
Update count: 0
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-09, 1396/07/17
Expected recruitment end date
2017-10-12, 1396/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on self-regulation education on reducing the anxiety of second-year high school students
Public title
Effect of education based on self-regulation education on reducing the anxiety of second-year high school students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Desire to participate in the study, high school students, female gender, lack of records of mental illnesses and residents of Mashhad
Exclusion criteria:
Exclusion criteria: unwillingness to continue cooperation, absence of maximum two training sessions, failure to answer more than 10% of questions to the questionnaire
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The cluster sampling method is used to select a randomly selected area from the 7 educational districts of Mashhad and select two state schools from the high school schools covered by the district and collect the samples
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
دانشگاه علوم پزشکی مشهد
Street address
خیابان دانشگاه -دانشگاه 18
City
مشهد
Province
Razavi Khorasan
Postal code
254649896456
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.MUMS.REC.1397.089

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Beck Anxiety Inventory Score
Timepoint
Before, immediately and 3 months after the intervention
Method of measurement
Beck Anxiety Inventory

2

Description
Mental Health Score
Timepoint
Before, immediately and 3 months after the intervention
Method of measurement
Mental Health Questionnaire

3

Description
Self-regulation score
Timepoint
Before, immediately and 3 months after the intervention
Method of measurement
Self-regulation questionnaire

Secondary outcomes

1

Description
Timepoint
Method of measurement

2

Description
Timepoint
Method of measurement

Intervention groups

1

Description
The intervention group received 4 sessions of 40 minutes to improve mental health and reduce anxiety.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Secondary High School Girls in Mashhad
Full name of responsible person
Dr. Noushin Peyman
Street address
University Street between 16-18
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3189 2110
Email
peymann@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Noushin Peyman
Street address
University College-University18- Faculty of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
36468547
Phone
+98 51 3854 1514
Email
peymann@mumus.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
Dr. Noushin Peyman
Position
Associate Professor of Health Education and Promotion of Health
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health Research Center of Health Faculty, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
365463
Phone
+98 31892110
Email
peymann@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Noushin Peyman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Health Effects Research Center, School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 1514
Email
peymann@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Noushin Peyman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion, University Street, between University Street 16-18
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 1514
Email
peymann@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data can be interchangeable after the differentiation of individuals
When the data will become available and for how long
Researchers who work at the University Researchers who work at the University
To whom data/document is available
Researchers who work at the university
Under which criteria data/document could be used
The data is sent via an official request and by email
From where data/document is obtainable
Dr. Noushin Peyman
What processes are involved for a request to access data/document
The data is sent via an official request and by email
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