Protocol summary

Study aim
Determining the effect of positive thinking educational intervention based on the theory of planned behavior on the self-esteem and happiness of teenage girls without an effective guardian in Shiraz
Design
The clinical trial will have a control group, which will be selected by the census method of 52 people, and random allocation will be done using a simple random method using a table of random numbers.
Settings and conduct
The location of the study will be the Darolekram Charity Center in Shiraz and the study population will be 52 teenager girls. Blinding has not been done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness and informed consent to participate in the study; Adolescent being unsupervised or poorly supervised; History of membership in the center for at least 6 months. Non-inclusion criteria: Receiving any treatment, psychological or medicinal (at least 6 months ago); having a history of training about positive thinking skills, self-esteem and happiness.
Intervention groups
Intervention group: The training will be face-to-face (lecture, group discussion, question and answer). Control group: no intervention. In order to comply with ethical considerations, training will be given to the control group after completing the research process.
Main outcome variables
Self-esteem, happiness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131014015015N22
Registration date: 2023-06-25, 1402/04/04
Registration timing: retrospective

Last update: 2023-06-25, 1402/04/04
Update count: 0
Registration date
2023-06-25, 1402/04/04
Registrant information
Name
Leila Ghahremani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ghahramanl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-13, 1402/02/23
Expected recruitment end date
2023-06-13, 1402/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of positive thinking educational intervention based on the theory of planned behavior on the self-esteem and happiness of adolescent girls without effective supervisor
Public title
The effect of teaching positive thinking on self-esteem and happiness of adolescents girl without effective supervisor
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and informed consent to participate in the study Adolescent being unsupervised or poorly supervised History of membership in the center for at least 6 months
Exclusion criteria:
Receiving any treatment, psychological or medicinal (at least 6 months ago) Having a history of training about positive thinking skills, self-esteem and happiness
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: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done by a simple random method using a table of random numbers. The unit of randomization will be people. The researcher will give codes to people in order and will also randomly start from a point in the table in the direction of row or column. The choice of the point can be done by closing the eyes and placing a finger or the tip of the pen on the table. Finally, 26 people will be divided into the intervention group and 26 people into 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
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand St. Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.016

Health conditions studied

1

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

Primary outcomes

1

Description
Self-esteem
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Rosenberg self-esteem questionnaire

2

Description
Happiness
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Oxford Happiness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:They will be invited to participate in the study and the objectives of the study will be explained to them, after assuring them of the confidentiality of the information, their informed consent will be obtained. In the next step, the information related to the positive thinking questionnaires , self-esteem and happiness will be collected. In this study, for the purpose of educational intervention, in the intervention group, the educational program will be implemented face-to-face and by the method of short lectures, group discussions, questions and answers according to the structures of behavioral theory, and will be held using educational aids such as (pamphlets, showing educational clips).Adolescents will be divided into small groups of 5-6 people and will receive 7 training sessions of 60 minutes. They will be given the questionnaires again one month later.
Category
Behavior

2

Description
Control group: They will not receive training during this period. Although, in order to comply with ethical considerations, the control group will be assured that after the completion of the research process, they will also receive this educational intervention. A month later, the questionnaires will be provided to them again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Darolekram Charity Center
Full name of responsible person
Sara Eskandari
Street address
Delavaran Basij Boulevard, 1 Sahab Alley, No. 63
City
Shiraz
Province
Fars
Postal code
۷۵۵۴۱ - ۷۱۵۳۶
Phone
+98 71 3725 1001
Email
sara.eskandarii1994@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Research and Technology Deputy; 7th Floor; Central Building of Shiraz University of Medical Sciences; Zand Street
City
Shiraz
Province
Fars
Postal code
۳۲۱۲۲۴۳۰
Phone
+98 71 3234 7966
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Eskandari
Position
Master's student in health education and health promotion
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
First floor; building number one; School of Public Health; in front of Electricity Club; Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3725 1001
Email
Sara.eskandarii1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahremani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
First floor; building number one; School of Public Health; in front of Electricity Club; Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3725 1001
Email
Ghahramanl@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara eskandari
Position
Master's student in health education and health promotion
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
First floor; building number one; School of Public Health; in front of Electricity Club; Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1725 7288
Email
sara.eskandarii1994@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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