The assessment of effect of cognitive-behavioral counseling on menopausal symptoms and quality of life in menopausal women : A Randomized Controlled Clinical Trial
Determine the effect of cognitive-behavioral counseling on menopausal symptoms and quality of life in menopausal women
Design
In this research, 90 postmenopausal women referring to Health Centers who are eligible for inclusion in the study are chosen . The participants are non- randomly divided into intervention and control groups.
Settings and conduct
In this study participants are elected by available sampling method from those referred to health centers in Tuiserkan city. after two groups distribution, the measures, including menopausal symptoms and quality of life in both groups by Greene Climacteric Scale and the World Health Organization's Quality of Life Questionnaire are carried out. For the intervention group, counseling process in the form of groups of 12-11 people with cognitive-behavioral approach, during a six- one hour meeting in the conference hall of Tuiserkan city health center will be held . After the intervention, measures will be repeated.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: Having a natural menopause (not due to drugs or surgery); The age of 47 to 57 years; Minimum 1 and maximum 4 years of their last normal menstrual have passed; Without any chronic or acute disease in the past 12 months with an intensity that person could not attend meetings; Not using hormone therapy to reduce menopausal symptoms; Exclusion criteria include: Not participating in two or more sessions of counseling; The use of hormone therapy during the study
Intervention groups
In the intervention group 6 one-hour cognitive-behavioral counseling session during 6 weeks will be held. in the control group, after the end of the assessments, a one-hour training session will be held.
Main outcome variables
Quality of life; Menopausal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151028024753N3
Registration date:2018-01-11, 1396/10/21
Registration timing:registered_while_recruiting
Last update:2018-01-11, 1396/10/21
Update count:0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Mitra Kolivand
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 9980
Email address
mitrakolivand@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of effect of cognitive-behavioral counseling on menopausal symptoms and quality of life in menopausal women : A Randomized Controlled Clinical Trial
Public title
The assessment of effect of cognitive-behavioral counseling on menopausal symptoms and quality of life in menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria include: Having a natural menopause (not due to drugs or surgery)
The age of 47 to 57 years
Minimum 1 and maximum 4 years of their last normal menstrual have passed
Without any chronic or acute disease in the past 12 months with an intensity that person could not attend meetings
Not using hormone therapy to reduce menopausal symptoms
Exclusion criteria:
Exclusion criteria include: Not participating in two or more sessions of counseling
The use of hormone therapy during the study
Age
From 47 years old to 57 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
75
Randomization (investigator's opinion)
Not 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 Kermanshah University of Medical Sciences
Street address
Building No. 2 of Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd. Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.KUMS.REC.1395.327
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states. Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention, after the intervention
Method of measurement
World Health Organization's Quality of Life Questionnaire
2
Description
Menopausal symptoms
Timepoint
Before the intervention, after the intervention
Method of measurement
Greene Climacteric Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group 6 one-hour cognitive-behavioral counseling session during 6 weeks will be held.
Category
Lifestyle
2
Description
Control group: In the control group, after the end of the assessments, a one-hour training session will be held.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Clinic
Full name of responsible person
Marzie Soori
Street address
17 Shahrivar Clinic, Enghelab Ave.Tuiserkan
City
Tuiserkan
Province
Hamadan
Postal code
٦٥٩١٦٣٩٩٣١
Phone
+98 83 3827 9899
Email
mrs.marziesoori@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzehee
Street address
Building No. 2 of Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd. Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 9899
Email
hamzehee@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Marzie Soori
Position
Master Student of Counselling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ashayer Ave., Isar Blv., School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 9899
Email
mrs.marziesoori@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Kolivand
Position
Student of Reproductive Health-PHD Degree-Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ashayer Ave., Isar Blv., School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 9899
Email
mitrakolivand@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Marzie Soori
Position
Master Student of Counselling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ashayer Ave., Isar Blv., School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 9899
Email
mrs.marziesoori@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is Shared after being unidentifiable.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific centers
Under which criteria data/document could be used
For use in other scientific researches after obtaining the consent of the responsible author
From where data/document is obtainable
mrs.marziesoori@yahoo.com
What processes are involved for a request to access data/document
Send an email to person responsible for scientific inquiries.After receiving the email,If you have conditions, the information will be sent to the requester.