Objective: this study assesses The effect of the edjucation program on quality of life in menopausal women Design: single-blind randomized clinical trial that will be conducted on 100 menopausesin health centers in Hamadan city. They will be randomly assigned to intervention and control groups with regard to Allocation concealment (50 in intervention group and 50 in control group). Setting and conduct: the eligible women who refer to health centers in 2016 will be enrolled. Inclusion criteria consisted of women: married and menopause women; quality of life score ≥ 50 ; had no history of physical and mental disorders ; and had not used hormone replacement therapy. Exclusion criteria consisted of women who ; unwillingness to continue cooperation and in duration of intervention be disorder. intervention: The edjucation program twice in week for 3 weeks will be gived and in control group the edjucation program not will be prescribed . Main outcome measures: the two groups will be compared in terms of the quality of life by MENQOL before the intervention, immediately after the intervention and 3 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510186888N13
Registration date:2016-02-10, 1394/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-10, 1394/11/21
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-04-29, 1395/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the edjucation program on quality of life in menopausal women in intervention and control groups
Public title
The effect of the edjucation program on quality of life in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consisted of women: married and menopause women; quality of life score ≥ 50 ; had no history of physical and mental disorders ; and had not used hormone replacement therapy. Exclusion criteria consisted of women who ; unwillingness to continue cooperation and in duration of intervention be disorder.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
UMSHA.REC.1394,7
Health conditions studied
1
Description of health condition studied
Quality of life in manopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Quality of life
Timepoint
before the intervention, immediately after intervention, 3 months after the intervention
Method of measurement
MENQOL Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention: The edjucation program twice in week for 3 weeks will be gived . the quality of life will be measured by MENQOL before the intervention, immediately after the intervention and 3 months after the intervention.
Category
Treatment - Other
2
Description
Control: in control group the edjucation program not will be prescribed .the quality of life will be measured by MENQOL before the study, immediately after the study and 3 months after the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical and Health Center
Full name of responsible person
Nahid Mohammadi, M.Sc. of Health, Instructor
Street address
No. 11, Takhti Street, Shohada Medical and Health Center, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Saied Bashirian
Street address
No. 307, Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
fshobeiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Ensiyeh jenabi
Position
Ph.D. student in Maternal and Child Health
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
en.jenabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan Universiy of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 818276051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)