1.Comparison of self-efficacy of premenopausal women in both intervention and control groups before intervention
2.Comparison of self-efficacy of premenopausal women in both intervention and control groups after intervention
3.Comparison of self-compassion of premenopausal women in both intervention and control groups before intervention
4.Comparison of self-compassion of premenopausal women in both intervention and control groups after intervention
Design
The clinical trial has a control group and one-way blind intervention. Sample size according to review studies and considering the level of confidence 95% and 80% test power were calculated according to the formula 35 people and considering 20% drop of 45 people in each group.
Settings and conduct
All actions will be performed in four sessions of forty-five minutes. The members of the intervention group will receive training based on the health belief model, while the control group will receive routine care. Questionnaires will be provided to participants in both groups three times before the intervention, immediately after the intervention and 1 month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. PreMenopausal women
2. Having Iranian nationality
Criteria for non-entry:
1. Having known malignant diseases
2. Not having a mobile phone if the training is virtual
Intervention groups
The members of the intervention group will be trained based on the health belief model, while the control group will receive routine cares.questionnaires will be available to participants three times before the intervention, immediately after the intervention and 1 month after the intervention and will completed in both groups.
Main outcome variables
Increasing self-efficacy in premenopausal women
Increasing the quality of life of premenopausal women
Increasing self-efficacy in premenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120414009463N66
Registration date:2022-04-19, 1401/01/30
Registration timing:registered_while_recruiting
Last update:2022-04-19, 1401/01/30
Update count:0
Registration date
2022-04-19, 1401/01/30
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-10, 1400/11/21
Expected recruitment end date
2022-05-02, 1401/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on health belief model on self-compassion and self - efficacy of premenopausal women
Public title
The effect of self-compassion and self - efficacy of premenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing
Pre menopausal women
Having Iranian nationality
Age minimum 40 years and maximum 50 years
Lack of chronic psychiatric disorders and known malignant diseases
Having a smart mobile phone if the training is virtual
Exclusion criteria:
Reluctance to continue participating in the study
Absence of more than 2 training sessions
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
IR.TUMS.FNM.REC.1400.144
Health conditions studied
1
Description of health condition studied
premenopausal disorders
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Self-efficacy and self-efficacy of premenopausal women in the intervention group
Timepoint
The effect of self-care and self-efficacy on premenopausal women
Method of measurement
Demographic Questionnaire Self-Sufficiency Questionnaire Self-Efficacy Questionnaire Health Belief Model Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Holding educational classes based on health belief model and education using educational videos and slides and using questionnaires before and after the intervention group
Category
Rehabilitation
2
Description
Control group: In the control group, which includes premenopausal women with intervention qualities, no intervention was performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers of Kerman University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
Higher_education@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
Zahrabehboodi@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran medical university
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
Zahra Behboodi Moghadam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
zahrabehboodi@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Assistant Professo
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6692 7171
Email
behboodi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
PHD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No1 , Dr. Mirkhani St. (Nosrat Sharghi) , Tohid Square ,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
Zahar_behboodi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' information is protected and their names are not required.
When the data will become available and for how long
1400
To whom data/document is available
Reputable journals
Under which criteria data/document could be used
Universities of Medical Sciences
From where data/document is obtainable
Try not to use the documents personally
What processes are involved for a request to access data/document