Protocol summary

Study aim
The effects of the counseling Based on self-Efficacy in menopausal symptoms management in peri menopausal women referred to health centers in mahabad in 2017-218
Design
The present study is a quasi-experimental, pretest-posttest with control group. Sampling in this study was done by selecting the health centers of Mahabad city randomly and selecting samples from each center. A total of 80 women were admitted to menopausal women in two groups (n = 40) and n = 40 (n = 40). The intervention group in this study was women of menopausal age who had criteria for entering the study. Control group In this study, women with menopausal status have criteria for entering the study
Settings and conduct
Firstly, a list of all health centers in Mahabad city was prepared. Subsequently, urban health centers were divided into two levels, 1 and 2, according to the opinion of the health center experts on the basis of cultural and socioeconomic status. At this stage each center's name was written in separate sheets and placed in a bag and selected by random method (simple random) from each center. At each level, a center for the control group and one center for the intervention group were assigned randomly from each node. From each center, 10 menopausal women were selected according to entry criteria.
Participants/Inclusion and exclusion criteria
Inclination to participate in research Iranian nationality Age between 45-55 years Residence in Mahabad city The absence of known physical, psychological and neurological diseases according to the patient No history of ovarian and uterine surgery Failure to develop artificial menopause.En Unwillingness to continue research Missing more than two sessions in counseling sessions The occurrence of any stressful incidents for a patient or first degree family Removal of the ovary and the womb Diagnosis of mental illness and psychiatric disorders during the study.
Intervention groups
Intervention group: The intervention group in this study was women of menopausal age who had inclusion criteria. Intervention for intervention group included self-efficacy counseling components on management of menopausal symptoms, which was performed in 6 sessions of a group of 45-60 minutes with intervals of one week The instruments used in this study were demographic questionnaire and Menopausal Symptom Scale questionnaire which was completed before and after counseling by the samples. Control group: Control group In this study, women were menopausal women who had criteria for entering the study They received routine care and a demographic questionnaire Menopausal scale was a questionnaire completed before and after counseling by samples
Main outcome variables
Independent variables in this research are self-efficacy-based counseling. The dependent variables in this study are menopausal symptoms and women around menopause. The underlying variables are age, the level of education of the wife and wife, the status of the wife and wife, the economic status, the length of the marriage by age, the menstruation, the number of pregnancies, the weight.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180108038275N1
Registration date: 2018-03-04, 1396/12/13
Registration timing: retrospective

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Bayaneh Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4233 2958
Email address
bayanrahimi57@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
2017-05-05, 1396/02/15
Actual recruitment end date
2017-07-06, 1396/04/15
Trial completion date
empty
Scientific title
The effects of the counseling Based on self-Efficacy in menopausal symptoms management in peri menopausal women
Public title
The effects of the counseling Based on self-Efficacy in menopausal symptoms management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in research Iranian nationality Age between 45-55 years Residence in Mahabad city The absence of known physical, psychological and neurological diseases according to the patient No history of ovarian and uterine surgery Failure to develop artificial menopause
Exclusion criteria:
Unwillingness to continue research Missing more than two sessions in counseling sessions The occurrence of any stressful incidents for a patient or first degree family Removal of the ovary and the womb Diagnosis of mental illness and psychiatric disorders during the study
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
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 Urmia University of Medical Sciences
Street address
No.26, Ebne Sina Ave
City
Mahabad
Province
West Azarbaijan
Postal code
5914867551
Approval date
2017-03-02, 1395/12/12
Ethics committee reference number
IR.Umsu.rec.1395.391

Health conditions studied

1

Description of health condition studied
Management of menopause symptoms
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Management of menopausal symptoms
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Menopause Rating Scale(MRS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group in this study was female menopausal women who had inclusion criteria. The intervention for the intervention group included self-efficacy counseling components on management of menopausal symptoms that was held in 6 sessions of a group of 45-60 minutes at intervals of one week. Tools The demographic questionnaire and the Menopausal Symptom Scale questionnaire, completed before and after counseling, were used in this study
Category
Rehabilitation

2

Description
Control group: The control group in this study was female menopausal women who had criteria for entering the study and received routine care. The demographic questionnaire and the menopausal scale scale questionnaire were completed before and after the consultation.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Mahabad city
Full name of responsible person
Bayaneh Rahimi
Street address
No. 26, Ebne Sina Ave
City
Mahabad
Province
West Azarbaijan
Postal code
5914867551
Phone
+98 44 4233 2958
Email
bayanrahimi57@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebi
Street address
No. 26, Ebne Sina Ave.
City
Mahabad
Province
West Azarbaijan
Postal code
5914867551
Phone
+98 44 4233 2958
Email
bayanrahimi57@yahoo.com
Grant name
Grant code / Reference number
7000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Bayaneh Rahimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.26, Ebne Sina Ave.
City
Mahabad
Province
West Azarbaijan
Postal code
5914867551
Phone
+98 44 4233 2958
Email
bayanrahimi57@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Bayaneh Rahimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 26, Ebne Sina Ave.
City
Mahabad
Province
West Azarbaijan
Postal code
5914867551
Phone
+98 44 4233 2958
Email
bayanrahimi57@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Bayaneh Rahimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 26, Ebne Sina Ave.
City
Mahabad
Province
West Azarbaijan
Postal code
5914867551
Phone
+98 44 4233 2958
Email
bayanrahimi57@yahoo.com

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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the data, such as information on the main outcome, can be shared
When the data will become available and for how long
Get started 6 months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
nobody
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
First, by email, and if not possible by contact number
Comments
Mail for correspondence
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