Determining the Effectiveness of Sexual Enrichment Counseling on Female Sexual Transition During Menopause
Design
A parallel clinical trial study with control and intervention groups.
Settings and conduct
The population of the study is 43-51 years old women referring to Shahreza health centers. Since all groups of people have the chance to enter the study, the centers, bases and bases of north, center and south of the city are randomly assigned to multiple centers or The base is selected. Randomly selected from each area in a ratio (1 center).The intervention group received 6 sessions of sexual enrichment counseling and each session lasted for 90 minutes.No blinding done.
Participants/Inclusion and exclusion criteria
Women aged 43 to 51 years, no underlying disease affecting sex, no drug use, no mental health problems, low primary literacy, no alcohol and drug abuse by any couple, having brief symptoms ( On the basis of the mrs questionnaire, mean score above), being married
Intervention groups
The intervention group received 6 sessions of sexual enrichment counseling and each session lasted for 90 minutes and the control group received no counseling.
Main outcome variables
The Effectiveness of Sexual Enrichment Counseling on Female Sexual Transition During Menopause.
Determination of mean score of sexual satisfaction in menopausal women before intervention in control and intervention groups
Determination of mean score of sexual satisfaction in menopausal women after intervention (2 and 4 weeks after intervention) in control and intervention groups
Comparison of mean sexual satisfaction between menopausal women before and after intervention in control and intervention groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045523N1
Registration date:2019-12-19, 1398/09/28
Registration timing:prospective
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Shahla Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5322 8768
Email address
shahla.jmll@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Sexual Enrichment Counseling on Sexual Satisfaction of perimenopausal Women: A Randomized Controlled Trial
Public title
Effectiveness of Sexual Enrichment Counseling on Sexual Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women ages 43 to 51 years
Minimum literacy
Having brief symptoms of menopause
Being married
Exclusion criteria:
Having underlying disease affecting sex
Having mental and psychological problems
Alcohol and drug use by each couple
taking medication
Age
From 43 years old to 51 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
A parallel clinical trial study.Samples were randomly divided into four blocks. Random Units: Stratified. Randomization Tool: Sealed Envelope.
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
Shahroud University of Medical Sciences
Street address
Haft Tir Square,Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
5615786346
Approval date
2019-11-22, 1398/09/01
Ethics committee reference number
IR.SHMU.REC.1398.101
Health conditions studied
1
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Menopausal Symptoms Score on MRS Scale
Timepoint
Measurement of sexual satisfaction before the start of the study and 2 and 4 weeks after the end of the sessions
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hold six sessions of sexual enrichment counseling and each session for 90 minutes
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز بهداشتی 17 شهریور,گلها,علی بن موسی
Full name of responsible person
Shahla Jamali
Street address
Shahid Yazdani
City
Shahreza
Province
Isfehan
Postal code
8888888888
Phone
+98 31 5322 8768
Email
shahla.jmll@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Haft Tir Square,Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5014
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
گیتی آتش سخن
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Haft Tir Square,Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3932 1850
Email
Gitiatashsokhan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Giti Atashsokhan
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Haft Tir Square,Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3932 1850
Email
Gitiatashsokhan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahla Jamali
Position
Ms Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Haft Tir Square,Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
5615786346
Phone
+98 23 3239 1805
Email
shahla.jmll@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is shared after unidentifiable people
When the data will become available and for how long
Start of access period 9 months after printing results
To whom data/document is available
Data will be available only to researchers working in academic and research institutions
Under which criteria data/document could be used
People are allowed to submit requests to obtain personally identifiable data or other documentation
From where data/document is obtainable
Shahla jamali,Shahroud University of Medical Sciences
What processes are involved for a request to access data/document