The aim of this study is to determine the effect of self-directed learning and support group styles on early menopause symptoms. In this clinical trial, 186 eligible women were randomized block 3 and 6 bits (determined by computer application) and a 1:1:1 ratio to one of three groups self-directed learning, support and control groups will be assigned. After completing the baseline characteristics and pre-test,to self- directed learning group instructional booklet will given in three weeks. instructional booklet is contains information relating to the acceptance and compliance with the early symptoms of menopause. support group sessions for three weeks will be held. At the beginning of each session, the researcher will provide Informations about the headlines and topics discussed in each session about 15 minutes of each session. then will be asked from participants to discuss of their strategies and experiences in the field their subject about 30 minutes and in the remaining 15 minutes, the researcher will gather contents. One month after the intervention, early menopause symptoms in the three groups will be assessed by the Greene scale. In the software spss version 13, ANCOVA test will be used to comparing the post-intervention mean scores of early symptoms of menopause between the groups with controlling the pre-intervention scores.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305063027N25
Registration date:2013-06-02, 1392/03/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-02, 1392/03/12
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz university of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-09-23, 1392/07/01
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 styles on early menopause symptoms
Public title
The effect of self-directed learning and support group styles on early menopause symptoms:A randomized controlled trialed
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1- Being menopause 2- Being married 3- Have at least secondry school education 4- age between 45 to 59 years old 5- At least 2 hotflushes per day. Exclusion criteria: 1- kidney, thyroid, heart – cardiovascular disease, diabetes, psychological and other systemic disease 2- taking estrogen or herbal medicines containing estrogen and phytoestrogens in the past three months 3- smoking, using of hubble-bubble and drinking Alcohol 4- severe stress such as the death of a family during the last 3 months 5- Surgical history of oophorectomy 6- Using of effective drugs on hot flashes including: clonidine, gabapentin, yohimbine.
Age
From 45 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
186
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz university of Medical Sciences, University St., Tabriz
City
Tabriz
Postal code
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
9217
Health conditions studied
1
Description of health condition studied
early menopause symptoms
ICD-10 code
95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Early menopause symptoms
Timepoint
Before intervention and 1 month after ending intervention
Method of measurement
Greene scale
Secondary outcomes
1
Description
Numbers of hotflushes
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Greene scale
Intervention groups
1
Description
Self- directed learning:Provide instructional booklet once a week for three consecutive weeks in the intervention group
Category
Lifestyle
2
Description
Support group:Training sessions once a week for three consecutive weeks for an hour in the intervention group
Category
Lifestyle
3
Description
Control :non intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr cooperative health centers
Full name of responsible person
Fahimeh Sehhatie Shafaie
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz university of Medical Sciences
Full name of responsible person
Dr. Kazem Shakouri
Street address
Golgasht st. Research Deputy of Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Deputy, Tabriz university of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
MSc on Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
sehhatief@tbzmed.ac.ir; fahimehsehhatie@yahoo.com
Web page address
http://www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
MSc on Midwifery, Academic member
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
sehhatief@tbzmed.ac.ir; fahimehsehhatie@yahoo.com
Web page address
http://www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)