Protocol summary

Study aim
Determining the effect of education based on self-management empowerment model on the sense of coherence, coping strategies and self-efficacy of girl adolescents with Internet Addiction
Design
A randomized controlled clinical trial; without blinding, parallel groups; with a sample size of 80 teenage girls who will be randomized into two intervention and control groups using Excel random numbers.
Settings and conduct
This study will be conducted in girls' schools of the first half of middle school in Bushehr city, after obtaining the relevant permits and sampling, first the necessary questionnaires will be completed by the sample and then the intervention based on the self-management empowerment model will be conducted in the mentioned areas for two months.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 12-14 years; moderate to high internet addiction score. Exclusion criteria: Having a known mental illness and taking psychiatric drugs affecting behavior and speech.
Intervention groups
In the intervention group, empowerment strategies will be implemented in the three areas of sense of coherence, coping strategies and self-efficacy, according to the self-management empowerment model in 5 steps. In such a way that the solutions will be taught to the patient in at least four 45-minute sessions with an interval of two weeks, depending on the conditions of the teenage girl with Internet addiction, and then the educational booklet will be presented to the patient. The control group will not receive any intervention.
Main outcome variables
sense of coherence; Efficacy; Coping strategies and Internet addiction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130422013092N11
Registration date: 2022-09-16, 1401/06/25
Registration timing: prospective

Last update: 2022-09-16, 1401/06/25
Update count: 0
Registration date
2022-09-16, 1401/06/25
Registrant information
Name
Maryam Ravanipour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
ravanipour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-08, 1401/07/16
Expected recruitment end date
2022-12-20, 1401/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education Based on Self-Management Empowerment Model on the Sense of Coherence, Coping Strategies and Self-Efficacy of Girl Adolescents with Internet Addiction
Public title
The Effect of Education Based on Self-Management Empowerment Model on the Sense of Coherence, Coping Strategies and Self-Efficacy of Girl Adolescents with Internet Addiction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 12-14 years old Studied in Bushehr high schools Having a moderate to high internet addiction score Having a device to connect to the Internet such as a smartphone Willingness and consent of the teenager and his parents to participate in the study
Exclusion criteria:
Having a known mental illness and taking psychiatric drugs affecting behavior and speech; Participation in other similar research.
Age
From 12 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will select and refer to two non-profit girls' schools and two public girls' schools of the first year of secondary school as a simple random sampling. The sample size includes 80 people, 20 people will be selected from each school. Based on the list of class names, the Internet addiction questionnaire is provided to the teenager to complete it. The completion of the questionnaire is continued by 3 levels until finally 20 people from each school whose score of internet addiction is medium to high are selected and assigned to two test and control groups based on the random numbers of the Excel software. In order to prevent the exchange of information between the two groups, there will be a public school in the test group and a public school in the control group, as well as a non-profit school in the test group and a non-profit school in the control group.
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
Resercher assistence Bushehr University of Medical Sciences
Street address
Busher, Sabzabad, next Salman Ffarsi hospital, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2022-09-14, 1401/06/23
Ethics committee reference number
IR.BPUMS.REC.1401.078

Health conditions studied

1

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

Primary outcomes

1

Description
attainment to sense of coherence
Timepoint
Before intervention، 2 month after intervention
Method of measurement
Antonovsky sense of coherence questionnaire

2

Description
attainment to Self Efficacy
Timepoint
En before intervention، 2 month after intervention
Method of measurement
Scherer General Self-Efficacy Questionnaire

3

Description
Attainment to problem-oriented coping strategies
Timepoint
En before intervention، 2 month after intervention
Method of measurement
Endler and Parker coping with stressful situations questionnaire

Secondary outcomes

1

Description
Achieving proper management in using the Internet
Timepoint
before intervention
Method of measurement
Young's Internet Addiction Questionnaire

Intervention groups

1

Description
Intervention group: After obtaining written consent from all the participants and completing the demographic information questionnaire, Antonovski's sense of coherence questionnaire, Endler and Parker's coping with stressful situations questionnaire and Scherer's general self-efficacy questionnaire will be completed. In the intervention group, strategies for empowering teenagers with Internet addiction in 3 areas of sense of coherence, coping strategies and self-efficacy will be carried out according to the self-management empowerment model in 5 steps. In such a way that the solutions depend on the conditions and needs of the teenager with internet addiction, in the form of face-to-face and individual interviews for two weeks, two 45-minute sessions are implemented every week, then the training booklet will be presented to the teenager, and after During this period, counseling and follow-up will be provided through phone calls for 6 weeks, and the proposed programs will be implemented for two months. For teenagers in the intervention group, self-management empowerment program training that includes the structural concepts of self-awareness of changes, independence, role function, adaptability, perceived satisfaction, sense of control and self-management will be implemented. The intervention will be implemented for 8 weeks in the intervention group. After two months, Antonovsky's sense of coherence questionnaire, Endler and Parker's coping with stressful situations questionnaire and Scherer's general self-efficacy questionnaire will be completed again by the intervention and control groups.
Category
Lifestyle

2

Description
Control group: Without the intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr public and non-profit schools
Full name of responsible person
Somaye Bashirinia
Street address
Bushehr, Ashuri, Baharestan Alley 50, Alley 2
City
Bushehr
Province
Boushehr
Postal code
7518759338
Phone
+98 903 892 9788
Email
somayebashirinia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Doctor Akram Farhadi
Street address
Busher, Sabzabad, next Salman Ffarsi hospital, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 903 892 9788
Email
ak.farhadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Somaye Bashirinia
Position
Master Nursing student, member of student research committee of Bushehr University of Medical Scienc
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
bushehr. sabzabad. next salman farsi hospital. bushehr university of medical sciences
City
Bushehr
Province
Boushehr
Postal code
7518759338
Phone
-
Email
somayebashirinia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Maryam Ravanipour
Position
Full Professor Department of Nursing. Research Center of Tropical Medicine and Infectious Persi
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Busher, Sabzabad, next Salman Ffarsi hospital, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
-
Phone
+98 77 3345 0187
Email
ravanipour@bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Somaye Bashirinia
Position
MSc student of nursing,Student Research Committee, Bushehr University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Pardis site, Bushehr University of Medical Sciences, next to the Salman Farsi hospital, Sabzabad
City
Bushehr
Province
Boushehr
Postal code
7518759338
Phone
-
Email
somayebashirinia@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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