Protocol summary

Study aim
Determining the effect of educational intervention based on self-regulation on Internet addiction and general health aspects of adolescents
Design
The clinical trial has a matched and randomized control group. In phase 2, it will be done on 120 people. The samples will be selected in the form of simple random sampling from one of the six areas of education. In this way, from one of the six educational districts of Isfahan City, one girl's school and one boy's school as the control group will be taken.
Settings and conduct
The intervention will be conducted in girls' and boys' secondary schools in Isfahan City in the form of group training sessions. In this study, 8 training sessions were considered during 2 months to carry out the intervention. The training that will be given includes the healthy use of the Internet, the effects of Internet addiction in social life, the introduction of appropriate methods to encourage the healthy use of the Internet, methods of dealing with Internet addiction, and creating awareness to set goals and achieve a behavior change.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Voluntariness and conscious participation, High school student, Having a smartphone, No mental problems. Exclusion criteria: Not willing to participate in research, not being a high school student, not having a smartcell phone, suffering from mental problems.
Intervention groups
In this study, 8 training sessions were considered for 2 months to carry out the intervention. during which the necessary training will be given to the intervention group. Then the effects of the intervention will be examined in the form of pre-test and post-test on both groups.
Main outcome variables
Goal setting, self-efficacy, outcome expectancies, outcome value, self-control, self-observation, self-reaction, general health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240120060737N1
Registration date: 2024-02-05, 1402/11/16
Registration timing: prospective

Last update: 2024-02-05, 1402/11/16
Update count: 0
Registration date
2024-02-05, 1402/11/16
Registrant information
Name
Fatemeh Fayazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3551 4363
Email address
fatemehfayazi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-23, 1402/12/04
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compilation and evaluation of the self-regulation program of Internet use on the general health of adolescents
Public title
Compilation and evaluation of the self-regulation program of Internet use on the general health of adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Voluntariness and conscious participation High school student Having a smart phone No mental problems
Exclusion criteria:
Unwillingness to continue cooperation at any stage of the research
Age
From 11 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 782
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by simple random sampling from one of the six education regions. In this way, in a simple random manner, from one of the six educational districts of Isfahan City, one girl's school as the intervention group and one girl's school as its control group, also one boy's school as the intervention group and one boy's school as the control group. The control group will be considered.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Modelling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174643461
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.MUI.DHMT.REC.1402.022

Health conditions studied

1

Description of health condition studied
Internet addiction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Internet addiction
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Internet addiction questionnaire

Secondary outcomes

1

Description
General health
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
General health questionnaire

Intervention groups

1

Description
Intervention group: It will include boys and girls of the high school level, who will receive an educational intervention including the correct use of the Internet in eight sessions for 2 months. And then the effects of the intervention will be evaluated.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
High school
Full name of responsible person
Zohre Fathian dastgerdi
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 913 305 1315
Email
z_fathian@hlth.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 31 8183 3668
Email
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
Zohre Fathian dastgerdi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 31 3792 3247
Email
z_fathian@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohre Fathian dastgerdi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 31 3792 3247
Email
z_fathian@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Fayazi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 61 3551 4363
Fax
+98 916 988 4010
Email
fatemehfayazi@hlth.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All information and reports obtained will be published in the form of articles and will be available to everyone.
When the data will become available and for how long
After completing the research
To whom data/document is available
For the general public
Under which criteria data/document could be used
For scientific use and to improve the level of knowledge in this field
From where data/document is obtainable
To receive any data or documents, you can get the information you need by communicating with the project manager and colleagues at the address of Isfahan University of Medical Sciences, Faculty of Health, or by email or other messaging networks.
What processes are involved for a request to access data/document
Calling and e-mail communication with the person in charge of the research z_fathian@hlth.mui.ac.ir fatemeh.fayazi200@gmail.com Mobile: 09169884010
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