Menopause causes a decrease in quality of life. Therefore, it is necessary to develop effective intervention program to improve quality of life after menopause. Support group is indicated as one of the most acceptable methods for providing information on the needs of the menopause. Women participating in such groups help each other through discussions by sharing of personal experiences and current information on menopause. Self- directed learning (SDL) is used in health interventions. SDL has become synonymous with self-mananged learning, lifelong learning and independent learning. The aim of this research is to evaluate the effect of self-directed learning & support group on quality of life after menopause. In a randomized control trial and single blind study, 155 postmenopausal women from Saadatmandy treatment & health center, Tehran, Iran, who have inclusion criteria of this study, will be randomly assined to three groups (two interventions groups, one control group). Data will be gathered with the menopause quality of life questionnaire (MENQOL) at baseline and 1 month after termination of the program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010022324N6
Registration date:2011-01-06, 1389/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-06, 1389/10/16
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Tehran Uiversity of Medical Sciences
Expected recruitment start date
2010-08-21, 1389/05/30
Expected recruitment end date
2010-12-02, 1389/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self- directed learning and support group on quality of life in menopause women
Public title
The effect of self- directed learning and support group on quality of life in menopause women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Healthy Iranian married women who have not had a hysterectomy, ability to read and write, Muslim, ceasing menstruation for 2-7 years, not using cigarette, Body mass Index (BMI) below of 30 Kg/m², not belonging to health care staff, have not used hormone replacement therapy during the preceding 6 months. Exclusion criteria: not willing to continue participation in per stage of study, not answering at least to one question in questionnaire, irregularly participating in weekly meetings, Happening unpleasant events during study , suffering from physically or emotional disease during study, using hormone replacement therapy during study.
Age
From 40 years old to 67 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
165
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
School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Rashid Yasami St. Valiasr Ave, P.O Box: 19395-4798
City
Tehran
Postal code
Approval date
2010-07-18, 1389/04/27
Ethics committee reference number
1744273
Health conditions studied
1
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
quality of life score
Timepoint
after 3 month
Method of measurement
Menopause specific quality of life (MENQOL) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Support group: four meetings, each meeting will be 120 min. Each meeting includes two sections (each section 60 min) which will be designed every week.
Category
Lifestyle
2
Description
Self directed learning group will be given four Guide books during four weeks.
Category
Lifestyle
3
Description
No intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Robat Karim Saadatmandy health and treatment center
Full name of responsible person
Dr Mohammad Hossain Moghadam
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing and Midwifery, Tehran Uiversity of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery, Tehran Uiversity 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
School of Nursing and Midwifery,Tehran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery,academic member, associated professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, ،Tehran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
Keshavarz_m@tums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran Uiversity of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery, academic member, associated professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
keshavarz_m@tums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran Uiversity of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery, academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
Email
keshavarz_m@tums.ac.ir , m_keshir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)