This study will be done with aim to investigate the effectiveness of cognitive-behavioral counseling on sexual satisfaction and quality of life of menopausal women. This study is a double blinded clinical trial. The study population will be included all menopausal women referred to health centers in Kermanshah city, that the number of 70 people will be selected and randomly will be assigned in to intervention and control groups of 35 persons. Beginning of the study, sexual satisfaction (SSSW) and quality of life of menopausal women questionnaires (MENQOL) will be available to both groups. The intervention group once a week (8 sessions, if necessary, will be increased to 10 sessions) for 90-70 minutes will receive cognitive-behavioral group counseling.The control group just will receive the usual care of center. A month after the last session of cognitive-behavioral group counseling, questionnaires will be provided for both groups again and sexual satisfaction and quality of life of both groups will be compared.
Inclusion criteria: Having natural menopause; Lack dementia; Lack of husband sexual dysfunction according to one asserted; Lack of family and marital conflict; Lack of heart and lung disease; Residing in the Kermanshah city.
Exclusion criteria: No participation in two or more sessions of counseling; Use of hormone therapy during the study; Any crisis in life during the study that make the patients physiological and subjective situation unfavorable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052814333N75
Registration date:2017-06-04, 1396/03/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-04, 1396/03/14
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effectiveness and non- effectiveness of cognitive-behavioral counseling on sexual satisfaction and quality of life of menopausal women
Public title
Effectives of cognitive behavioral counseling on sexual satisfaction and quality of life in menopaus women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having natural menopause; Lack dementia; Lack of husband sexual dysfunction according to one asserted; Lack of family and marital conflict; Lack of heart and lung disease; Residing in the Kermanshah city.
Exclusion criteria: No participation in two or more sessions of counseling; Use of hormone therapy during the study; Any crisis in life during the study that make the patients physiological and subjective situation unfavorable
Age
From 47 years old to 57 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by Card
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, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
kums.rec.1396.6
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
Primary outcomes
1
Description
Quality of Life
Timepoint
Beginning of the study, one month after the end of the study
Method of measurement
Based on The Menopausal Specific Quality of Life Questionnaire (MENQOL)
2
Description
Sexual satisfaction
Timepoint
Beginning of the study, one month after the end of the study
Method of measurement
Based on sexual satisfaction questionnaires (SSSW)
Secondary outcomes
empty
Intervention groups
1
Description
The control group just will receive the usual care of center.
Category
Other
2
Description
The intervention group once a week (8 sessions, if necessary, will be increased to 10 sessions) for 90-70 minutes will receive cognitive-behavioral group counseling.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Kermanshah city
Full name of responsible person
Sharareh
Street address
Motazedi Health centers, Street of Hafeziyeh
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sharareh Khoshandam
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
sharareh.khoshandam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sosan Heydarpour
Position
Ph.D. in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
heydarpour1394@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sharareh Khoshandam
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
sharareh.khoshandam@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)