Evaluation of the effect of couple training based on self-efficacy theory on quality of life, self-efficacy and health literacy in postmenopausal women
Determining the effect of educational intervention of couples in menopausal age based on self-efficacy theory on quality of life, health literacy and self-efficacy in postmenopausal women in Mashhad
Design
This research was a semi-experimental study. First of all, in the descriptive stage, participants were determined in 5 health center of Mashhad according to the number of samples. They were married women with lived husbands in the age range of 45_60 years old.
Then in the next level, one center was chosen randomly from the five centers in Mashhad, and four comprehensive centers were randomly selected from that center. Two centers were assigned as experimental group and two centers were assigned as control group.
Settings and conduct
Menopause women aged 45-60 years old referring to Mashhad comprehensive health centers in Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women at the age of 45-60 years;
living with husband;
physiologically menopaused;
Passed 1-10 years from menstruation pause;
Willingness to participate in this study.
Non-compliance criterion: history of hormone therapy over the past 6 months; History of hysterectomy;
Not being Iranian;
Severe physical or mental illness.
Intervention groups
In this study, married menopausal women referring to comprehensive health centers of Mashhad city will be randomly assigned into two groups of test and control groups. In the test group, educational intervention will be based on the theory of self-efficacy. The control group will not receive any training.
Main outcome variables
Self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160710028863N28
Registration date:2018-06-24, 1397/04/03
Registration timing:retrospective
Last update:2018-06-24, 1397/04/03
Update count:0
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of couple training based on self-efficacy theory on quality of life, self-efficacy and health literacy in postmenopausal women
Public title
The effect of couples training on quality of life, health literacy and self-efficacy of postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women at the age of 45-60 years
living with husband
physiologically menopaused
Passed 1-10 years from menstruation pause
Willingness to participate in this study
Exclusion criteria:
history of hormone therapy over the past 6 months
History of hysterectomy
Not Iranian
Severe physical and mental illness
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
This research was a semi-experimental study. First of all, in the descriptive stage, participants were determined in 5 health center of Mashhad according to the number of samples. They were married women with lived husbands in the age range of 45_60 years old.
Then in the next level, one center was chosen randomly from the five centers in Mashhad, and four comprehensive centers were randomly selected from that center. Two centers were assigned as experimental group and two centers were assigned as control group.
Experimental and control groups were homogenized and had acceptable distance from each other.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Between Daneshgah16 and Daneshgah18, Danshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.MUMS.REC.1397.011
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Self efficacy
Timepoint
Before The intervention, immediately and three months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Health literacy
Timepoint
Before The intervention, immediately and three months after intervention
Method of measurement
Questionnaire
2
Description
Quality of life
Timepoint
Before The intervention, immediately and three months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Health educational intervention is based on self-efficacy theory in the intervention group. The number and content of sessions and the duration of the course will be determined through need assessment in the descriptive phase of the study.
Category
Behavior
2
Description
Control group: The control group will not receive any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Comprehensive Health Centers
Full name of responsible person
Nooshin Peyman
Street address
School of Health, Daneshgah18 Avenue, Danshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3854 1514
Email
peymann@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah18, Danshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3854 1514
Email
peymann@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Daneshgah18 Avenue, Danshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3854 1514
Fax
Email
peymann@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah18 Street, Danshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3854 4633
Fax
Email
peymann@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Position
Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Daneshgah18 Avenue, Danshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3854 1514
Fax
Email
peymann@mums.ac.ir
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
the access period will be start one month after the result is published
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Dr Nooshin Peyman Peymann@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email