Target: evaluate the effect of education on self-care, based on Orem self-care model on self-care behaviors and quality of life menopausal women. Designing: randomized clinical trial. How do: in health centers of Saghez will be done. 130 of menopausal women aged 45 to 55 with blocks 4 and 6 with allocation ratio of 1: 1 Placed into two groups Intervention and control. A member of the research team uninvolved in the selection of samples, random allocation sequence using a computer program will determine.Participants using a randomized. Sealed opaque envelope numbered sequentially allocation will be used for concealment of allocation. Inclusion criteria: natural menopasue; lack of participation in sijmilar studies; access to cell phone; no Known history of mental illness. Exclusion criteria: implemention of hormone replacment therapy; giving any type of education in menopausal area and need for surgical intervention. Intervention: in the intervention group; four one-hour group training session on the basis of Orem self-care and the results of the self-care questionnaire completed in the first session.one personal training session will be conducted based on specific needs. The main educational content determined according to the Ministry of Health booklets and reference books. In the control group after the end of the study and completing the questionnaires, pamphlets will be taught. The main outcome variables: Self-care behavior scores before and 4 weeks after intervention and individual outcomes: quality of life before and 4 weeks after the intervention will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020221917N6
Registration date:2016-06-10, 1395/03/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences-Faculty of Nursing and Midwifery
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on Orem self care model on self care behavior and quality of life in menopausal women: a randomized controlled trial
Public title
Effect of education based on Orem self care model on self care behavior and quality of life in menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: menopaual women aged rane between 45- 55; Passing one year from the last date of menstruation;natural menopasue; lack of participation in sijmilar studies; access to cell phone; no Known history of mental illness. Exclusion criteria: implemention of hormone replacment therapy; not wanting to continue the study; impossibility of attending a training class; giving any type of education in menopausal area; mental disorders; surgical intervention.
Age
From 45 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
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 Tabriz University of Medical Sciences
Street address
Number 2 central building, third floor, research and technology department, Golgasht street, Azadi avenue, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
tbzmed.rec.1394.971
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
2
Description of health condition studied
Self care in menopause
ICD-10 code
N95.8
ICD-10 code description
Other specified menopausal and perimenopausal disorders
3
Description of health condition studied
Quality of life
ICD-10 code
Z73.9
ICD-10 code description
Problem related to life-management difficulty, unspecified
Primary outcomes
1
Description
Self-care behavior
Timepoint
Baseline, forth weeks after intervention
Method of measurement
Orem self care questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Baseline, forth weeks after intervention
Method of measurement
12-Item short form health survey
Intervention groups
1
Description
In the control group; after the end of the study and completing the questionnaires, pamphlets will be taught.
Category
N/A
2
Description
In The intervention group; group and individual training will be done.four one-hour group training session on the basis of Orem self-care and the results of the self-care questionnaire completed in the first session.one personal training session will be conducted based on specific needs.