Protocol summary

Study aim
The main objective : Determining the effect of group reality therapy based on selection theory on social anxiety and self-efficacy of students with cell phone dependence. Secondary objectives: 1. Determining and comparing the social anxiety of students with cell phone dependence in the two groups of test and control before and after the intervention; 2. Determining and comparing the self-efficacy of students with mobile phone dependence in two experimental and control groups before and after the intervention.
Design
Clinical trial with intervention and control groups that are selected by simple random allocation by sampling method.
Settings and conduct
Sampling place: from virtual groups of nursing students studying ( due to corona virus coditions). How to do it: In a simple random allocation and by lottery method. A total of 52 people enter the study and are assigned to two groups of test and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Students who were undergraduate nursing in Tehran University of Medical Sciences. 2. Students who received a score higher than 43 from the Kuh-e-He mobile phone dependency questionnaire. 3. Students who are not under another educational or medical program at the same time as the educational program. Exclusion criterion: Absence of more than two sessions in reality therapy sessions.
Intervention groups
The intervention group learns reality therapy based on selection theory in 6 sessions of 1.5 hours and the control group does not learn any intervention or training.
Main outcome variables
If the positive effect of group reality therapy based on choice theory on social anxiety and self-efficacy of individuals, administrators and educational policy makers can use this therapeutic approach as a group in schools, universities and all young people to manage low self-efficacy and social anxiety due to dependence.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210424051059N1
Registration date: 2021-06-21, 1400/03/31
Registration timing: registered_while_recruiting

Last update: 2021-06-21, 1400/03/31
Update count: 0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
kimiya darabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 5169
Email address
kimiyad74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-29, 1400/03/08
Expected recruitment end date
2021-06-29, 1400/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Group Reality Therapy Based on Choice Theory on Social Anxiety and Self-efficacy of Students with Cell Phone Addiction
Public title
The Impact of Group Reality Therapy Based on Choice Theory on Social Anxiety and Self-efficacy of Students with Cell Phone Addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Students who were undergraduate nursing in Tehran University of Medical Sciences. Students who received a score higher than 43 from the Kuh-e-He mobile phone dependency questionnaire. Students who are not under another educational or medical program at the same time as the educational program.
Exclusion criteria:
Absence of more than two sessions in reality therapy sessions
Age
From 15 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
All nursing students, members of the Tehran School of Nursing and Midwifery, were asked to complete an online questionnaire on demographic information and cell phone dependence, if possible and desired. Then, 58 students were randomly selected from the students completing the questionnaire based on the inclusion criteria, and were divided into two groups of test (intervention) and control by simple random allocation using the lottery method. First, a list of eligible people was prepared, then a number from one to 58 was assigned to each of them, and by drawing lots, the numbers were written on pieces of paper and placed in a container and mixed well to make a sample. With a certain volume of each intervention and control group was determined. According to the method of determining the sample size based on the opinion of the professor of statistics, a maximum of 58 people entered the study, of which 52 people in total and 26 people in each test and control group, taking into account the loss of 10% of the sample.
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 the School of Nursing and Midwifery and the School of Rehabilitation, Tehran Uni
Street address
Office of the Vice Chancellor for Research, First Floor, Building No. 1 of the Faculty of Medicine, North Door of the University, Poursina St,Ghods St, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.083

Health conditions studied

1

Description of health condition studied
Mobile Dependence
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mobile Dependence: A score above 43 of the Kuh-e Hey Mobile Dependency Questionnaire
Timepoint
At the beginning of the study: to determine the conditions for inclusion in the study
Method of measurement
Using Kuh-e-Hey mobile phone dependency questionnaire

2

Description
Social Anxiety: The score that a person gets from the Jorabak Social Anxiety Questionnaire.
Timepoint
At the beginning and end of sampling
Method of measurement
Using Jorabak Social Anxiety Questionnaire

3

Description
Self-efficacy: is the score that the subject obtains in the Scherer and Maddox (1982) self-efficacy questionnaire.
Timepoint
At the beginning and end of sampling
Method of measurement
Using Scherer and Maddox self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Teaching them 6 sessions of 1/5 hour reality therapy based on selection theory
Category
Treatment - Other

2

Description
Control group: Not receiving any intervention and training
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Kimiya Darabi
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
kimiyad74@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Granmaye
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4567
Email
fnm-researchdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kimiya Darabi
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, School of Nursing and Midwifery, Dr. Mirkhani St. (Eastern Nusrat), Tohid Square.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
kimiyad74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kimiya Darabi
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, School of Nursing and Midwifery, Dr. Mirkhani St. (Eastern Nusrat), Tohid Square.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
kimiyad74@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kimiya Darabi
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, School of Nursing and Midwifery, Dr. Mirkhani St. (Eastern Nusrat), Tohid Square.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
kimiyad74@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
Not applicable
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