Determining the Effect of Mariana on Sexual Function and Sexual Satisfaction of Married Women of Reproductive Age Referred to Ardabil Health Centers in 2019
Design
This study is a clinical trial with randomized, double-blind, and control blocks.
Settings and conduct
The research community will include married women who visit health centers.
People will receive the Gender Sexual Function Index (FSFI) questionnaire to determine their sexual function and people with a sexual function score below 28 (sexual dysfunction) will be included in the study as a unit of study and will receive a standard Larson sexual satisfaction questionnaire to determine their sexual satisfaction.
The subjects were randomly divided into two groups of case and control.
Gels will be provided to research units along with the FSFI questionnaire. Each research unit will be given a 30 gr tube. The vaginal unit will use vaginal gel for 4 weeks, 2 times a week and every half hour before an applicator approaches.
Participants/Inclusion and exclusion criteria
The research population included all married women referring to Ardabil health centers in 2019-2020
The criteria for entering units in this study will be: Age of 45-15 years
Having a history of at least one year of having sex with her husband
Voluntary consent to participate in the research
Having a minimum level of education at the third level of middle school
Exit criteria will be:Menopause
Having any kind of physical illness and mental disorders in one individual and her husband
The use of any psychoactive substance or psychoactive substance or sexual drugs during the intervention by the individual and her husband
Pregnancy or having a pregnancy intention
Intervention groups
Mariana group. Placebo group
Main outcome variables
sexual function.sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190425043369N1
Registration date:2019-11-30, 1398/09/09
Registration timing:prospective
Last update:2019-11-30, 1398/09/09
Update count:0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Elham Najafi Mollabashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 1831
Email address
elhamnajafi94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-23, 1398/10/02
Expected recruitment end date
2020-02-21, 1398/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mariana on sexual function and sexual satisfaction of women in reproductive age
Public title
The effect of Mariana on sexual function and sexual satisfaction of women in reproductive age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45-15 years
Having a history of at least one year of having sex with her husband
Voluntary consent to participate in the research
Having a minimum level of education at the third level of middle school
Exclusion criteria:
Menopause
Having any kind of physical illness and mental disorders in one individual and her husband
The use of any psychoactive substance or psychoactive substance or sexual drugs during the intervention by the individual and her husband
Pregnancy or having a pregnancy intention
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly divided into two intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
For this purpose, each of the two drugs will be prepared in identical shapes and will be provided by the pharmacist in packages with codes A and B and will be presented with the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Biomedical Research of Ardabil University of Medical Sciences
Street address
Ferdowsi Street. Ferdows Alley
City
Ardabile
Province
Ardabil
Postal code
5615675494
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.ARUMS>REC.1398.440
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
2
Description of health condition studied
sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual performance
Timepoint
At the beginning of the study and after a month of using the gel
Method of measurement
Female Sexual Function Index, FSFI
2
Description
sexual satisfaction
Timepoint
At the beginning of the study and after a month of using the gel
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mariana group
Category
Treatment - Drugs
2
Description
Control group: Placebo group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Hatam
Street address
Saadi ST
City
Ardabil
Province
Ardabil
Postal code
5615675494
Phone
+98 45 3372 1831
Email
elhamnajafi94@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Moolaei
Street address
Saaedi ST
City
Ardabil
Province
Ardabil
Postal code
561567896
Phone
+98 45 3371 3272
Email
gamisi11@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Elham Najafi Mollabashi
Position
coach
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Saedi ST
City
Ardabil
Province
Ardabil
Postal code
5615675494
Phone
+98 45 3372 1831
Email
elhamnajafi94@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Elham Najafi Mollabashi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Saedi ST
City
Ardabil
Province
Ardabil
Postal code
5615675494
Phone
+98 45 3372 1831
Email
elhamnajafi94@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Elham Najafi Mollabashi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Saedi St
City
Ardabil
Province
Ardabil
Postal code
5615675494
Phone
+98 45 3372 1831
Email
elhamnajafi94@yahoo.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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
Start the access period 12 months after printing the results