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Evaluation of an educational intervention based on transtheoretical model in treating of internet gaming disorder among adolescents in Abyek city

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History
# Registration date Revision Id
2 2020-08-22, 1399/06/01 148462
1 2020-06-10, 1399/03/21 138248
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    Green color represents new content. It may be empty showing deletion in the new version.

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  • General information

    2020-05-13, 1399/02/24
    2021-04-09, 1400/01/20
    2020-11-14, 1399/08/24
    2021-06-10, 1400/03/20
    empty
    Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed.
    empty
    با توجه به تغییر شرایط سلامت عمومی و به علت بیماری کرونا ویروس، زمان انجام نمونه گیری مطالعه تغییر کرده است.
    Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed.
    با توجه به تغییر شرایط سلامت عمومی و به علت بیماری کرونا ویروس، زمان انجام نمونه گیری مطالعه تغییر کرده است.

  • Secondary outcomes

    #1
    empty
    Recognize the individual's position in the cycle of stages of change
    empty
    تشخیص جایگاه فرد در چرخه مراحل تغییر
    empty
    To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
    empty
    برای ارزیابی شرکت کنندگان،آنها به سوالات پرسشنامه قبل از مداخله، یک و سه ماه پس از شروع مداخله پاسخ می دهند.
    empty
    Questionnaire of Structural Stage of change of Transtheoretical Model
    empty
    پرسشنامه سازه مراحل تغییر مدل فرانظری
    #2
    Sleep hygiene
    Self-efficacy score
    بهداشت خواب
    نمره خودکارآمدی
    Insomnia severity index(ISI)
    Questionnaire of Structural Self-Efficacy of Transtheoretical Model
    پرسشنامه شاخص شدت بی خوابی
    پرسشنامه سازه خودکارآمدی مدل فرانظری
    #3
    Depression Anxiety Stress Scales
    Decision Balance Score
    نمره استرس،اضطراب و افسردگی
    نمره موازنه تصمیم گیری
    Depression Anxiety Stress Scales (DASS)
    Questionnaire of Structural Decision Balance of Transtheoretical Model
    پرسشنامه مقیاس استرس، اضطراب، افسردگی
    پرسشنامه سازه موازنه تصمیم گیری مدل فرانظری
    #4
    Self-efficacy score
    empty
    نمره خودکارآمدی
    empty
    To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
    empty
    برای ارزیابی شرکت کنندگان، آنها به سوالات پرسشنامه، قبل از مداخله، 1 و 3 ماه پس از شروع مداخله پاسخ می دهند.
    empty
    Questionnaire of Structural Self-Efficacy of Transnational Model
    empty
    پرسشنامه سازه خودکارآمدی مدل فرانظری
    empty
    #5
    Decision Balance Score
    empty
    نمره موازنه تصمیم گیری
    empty
    To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
    empty
    برای ارزیابی شرکت کنندگان، آنها به سوالات پرسشنامه، قبل از مداخله، 1 و 3 ماه پس از شروع مداخله پاسخ می دهند.
    empty
    Questionnaire of Structural Decision Balance of Transnational Model
    empty
    پرسشنامه سازه موازنه تصمیم گیری مدل فرانظری
    empty

  • Recruitment centers

    #1
    Name of recruitment center - English: Abyek High School
    Name of recruitment center - Persian: مدارس متوسطه شهر آبیک
    Full name of responsible person - English: Sara Fazeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Street address - English: Moallem Sq,Education Department,Abyek Town
    Street address - Persian: آبیک، میدان معلم،اداره آموزش و پرورش شهر آبیک
    City - English: Abyek
    City - Persian: آبیک
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3414613685
    Phone: +98 28 3282 3347
    Fax: +98 28 3334 1172
    Email: caspian@medu.ir
    Web page address:
    Name of recruitment center - English: Abyek High School
    Name of recruitment center - Persian: مدارس متوسطه شهر آبیک
    Full name of responsible person - English: Sara Fazeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Street address - English: Moallem Sq,Bahonar Blvd,Education Department,Abyek Town
    Street address - Persian: آبیک، میدان معلم، بلوار باهنر، اداره آموزش و پرورش شهر آبیک
    City - English: Abyek
    City - Persian: آبیک
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3414613685
    Phone: +98 28 3282 3347
    Fax: +98 28 3334 1172
    Email: caspian@medu.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Mahdi Emam Jomeh
    Full name of responsible person - Persian: محمدمهدی امام جمعه
    Street address - English: Bahonar Blvd., Qazvin University of Medical Sciences.,Qazvin Town
    Street address - Persian: قزوین - بلوار شهید باهنر - دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3333 6001
    Fax:
    Email: info@qums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Pakpour
    Full name of responsible person - Persian: امیر پاکپور
    Street address - English: Bahonar Blvd., Qazvin University of Medical Sciences.,Qazvin Town
    Street address - Persian: قزوین - بلوار شهید باهنر - دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3333 6001
    Fax:
    Email: apakpour@qums.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sara Fzeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Position - English: Master of Science Student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.14.,2 Alley., Golha Ave.,Khorram Town
    Street address - Persian: شهرک خرم، خیابان گلها،کوچه 2،پلاک 14
    City - English: Abyek
    City - Persian: آبیک
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3441878613
    Phone: +98 28 3282 1969
    Mobile: +98 919 189 7511
    Fax:
    Email: s.fazelirooshande@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sara Fzeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Position - English: Master of Science Student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Bahonar Blvd., Qazvin University of Medical Sciences
    Street address - Persian: بلوار شهید باهنر،دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3336 9581
    Mobile: +98 919 189 7511
    Fax:
    Email: s.fazelirooshande@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sara Fazeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Position - English: Master of science student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.14.,2 Alley.,Golha Ave.,Khorram Town
    Street address - Persian: شهرک خرم،خیابان گلها، کوچه دوم،پلاک 14
    City - English: Abyek
    City - Persian: آبیک
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3441878613
    Phone: +98 28 3282 1969
    Mobile: +98 919 189 7511
    Fax:
    Email: s.fazelirooshande@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sara Fazeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Position - English: Master of science student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Bahonar Blvd., Qazvin University of Medical Sciences
    Street address - Persian: بلوار شهید باهنر،دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3336 9581
    Mobile: +98 919 189 7511
    Fax:
    Email: s.fazelirooshande@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the effectiveness of an educational intervention based on transtheoretical model in treating of internet gaming disorder among adolescents in Abyek
Design
This study is randomly divided into parallel groups, two intervention and control groups with a sample size of 206 people.Out of 25 schools, 8 schools will be selected and 4 schools will be selected in the intervention group and 4 schools will be selected in the control group and then 30 people from each random school will be selected.
Settings and conduct
First,Abyek high school students will be sent an online questionnaire about internet gaming disorder and the insomnia severity index through social media.People with a score above 45 are randomly assigned to two intervention and control groups,the intervention group of the designed educational application receives the treatment of internet gaming disorder.The control group is trained on sleep hygiene.Before, one and three months after the end of the training, the questionnaires will be answered online again to evaluate the impact of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The desire to participate in the study;diagnosis of internet gaming disorder among students through the relevant questionnaire;access to computer, tablet or smartphone exclusion criteria:age over 18 years;non-addiction to online games
Intervention groups
Based on the transtheoretical model and cognitive-behavioral therapy, the educational application intervention group receives 30 to 45 minutes in eight sessions in an educational package,control group training is about sleep hygiene.To assess the impact of the intervention, individuals fill out questionnaires in the app one and three months after the end of the training.
Main outcome variables
Online play time;Online game addiction score

General information

Reason for update
Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed.
Acronym
IRCT registration information
IRCT registration number: IRCT20181226042140N1
Registration date: 2020-06-10, 1399/03/21
Registration timing: prospective

Last update: 2020-08-25, 1399/06/04
Update count: 1
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
sara fazelirooshande
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
s.fazelirooshande@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of an educational intervention based on transtheoretical model in treating of internet gaming disorder among adolescents in Abyek city
Public title
The effect of intervention of internet gaming disorder among adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in research Busy studying Diagnosis of internet gaming disorder in students through the internet gaming disorder scale–short-form Internet access Access to computer, laptop, tablet or smartphone Gain a score of 45 or higher on the evaluation of the initial questionnaire on internet gaming disorder Ability to answer questionnaire questions Lack of mental illness (such as schizophrenia and bipolar disorder) or mental disability
Exclusion criteria:
Age over 18 years Non-addiction to online games
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 206
Randomization (investigator's opinion)
Randomized
Randomization description
This research is a randomized trial study of a single blind.By simple randomization, out of a total of 25 schools, 8 schools are randomly selected.Out of 8 schools, 4 are randomly assigned to control groups and 4 to random experimental groups.From each school, 30 students will be randomly selected.From each school,the number of students selected will receive a special code through the SPSS software,and then,after analyzing the data,they will be randomly selected through this codes. In each selected cluster, all students who played video games are selected.Subjects will be randomly divided into intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.QUMS.REC.1398.358

Health conditions studied

1

Description of health condition studied
Internet gaming disorder
ICD-10 code
DSM-5
ICD-10 code description
Internet gaming disorder

Primary outcomes

1

Description
Online game addiction score
Timepoint
Before the intervention and 1 and 3 months after the start of the intervention
Method of measurement
Internet Gaming Disorder Scale–Short-Form

Secondary outcomes

1

Description
Insomnia Severity Index
Timepoint
To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
Method of measurement
Insomnia Severity Index (ISI)

2

Description
Scores of stress, anxiety, depression
Timepoint
To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
Method of measurement
Depression Anxiety Stress Scales (DASS)

3

Description
Recognize the individual's position in the cycle of stages of change
Timepoint
To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
Method of measurement
Questionnaire of Structural Stage of change of Transtheoretical Model

4

Description
Self-efficacy score
Timepoint
To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
Method of measurement
Questionnaire of Structural Self-Efficacy of Transtheoretical Model

5

Description
Decision Balance Score
Timepoint
To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
Method of measurement
Questionnaire of Structural Decision Balance of Transtheoretical Model

Intervention groups

1

Description
Intervention group: The educational application is designed based on the transtheoretical model and cognitive-behavioral therapy.The tutorials are designed for 8 sessions of 30 to 45 minutes.The content of the sessions includes increasing awareness and investigating the effect of internet gaming on people's physical and mental health; It is also about identifying misconceptions about online games and it also identifies and corrects misconceptions about online games.Part of this training also includes self-control, coping responses, and overcoming temptation.
Category
Behavior

2

Description
Control group: Online educational sessions are designed in 8 sessions, 30 minutes with the topic of sleep hygiene.The content of the sessions is designed to increase knowledge and improve sleep hygiene behavior,sleep habits,sleep management,identify incorrect patterns of behavior associated with sleep,and the impact of the environment, time, physical activity and nutrition on people's sleep.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Abyek High School
Full name of responsible person
Sara Fazeli Rooshande
Street address
Moallem Sq,Bahonar Blvd,Education Department,Abyek Town
City
Abyek
Province
Qazvin
Postal code
3414613685
Phone
+98 28 3282 3347
Fax
+98 28 3334 1172
Email
caspian@medu.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour
Street address
Bahonar Blvd., Qazvin University of Medical Sciences.,Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
apakpour@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Sara Fzeli Rooshande
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Blvd., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3336 9581
Email
s.fazelirooshande@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determinants of Health Research Center.,Shahid Bahonar Blvd., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3334 4589
Fax
+98 28 3335 0056
Email
apakpour@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sara Fazeli Rooshande
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Blvd., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3336 9581
Email
s.fazelirooshande@gmail.com

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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