Determining the effect of sexual behavior training on sexual function of pregnant women in the second and third trimesters
Design
Randomized clinical trial with control group, four parallel group trial; two groups of intervention and control group were selected. This group according to whether or not you participate in pregnancy classes have two sub group.
The sample size for each sub group was 21. Given the 10% drop in samples, the sample size was estimated to be 25 in each sub group.
Settings and conduct
50 pregnant women referred to pregnancy classes in Sayyad Shirazi Hospital were selected by convenience sampling and randomly assigned to two groups.
The first group, in addition to routine pregnancy training, will receive sexual education during pregnancy and the second group will receive the same routine pregnancy training.
At the same time, 50 mothers pregnant mothers who referred to the prenatal clinic of Gorgan health centers were selected by convenience sampling and randomly assigned to two groups. The first group will receive only sex education and the second group will not attend any class.
In the first two groups, the FSFI was completed and eight weeks after the completion of the training sessions,and questionnaire will be completed.
and in the group without any training, the questionnaire will be completed eight weeks later.
Participants/Inclusion and exclusion criteria
Primiparus pregnant woman; age between 18 and 35 years old; healthy fetus; single fetus; having satisfaction.
Intervention groups
Persons in itervention group will be participate in sexual behavior training class.
Control group who have not participated in any sexual educational class.
Main outcome variables
Sexual function of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039735N1
Registration date:2018-07-17, 1397/04/26
Registration timing:registered_while_recruiting
Last update:2018-07-17, 1397/04/26
Update count:0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Fateme Seifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
fateme.seifi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
2017-09-11, 1396/06/20
Actual recruitment end date
2018-09-11, 1397/06/20
Trial completion date
empty
Scientific title
The effect of education of sex behavior in the pregnant women's sexual function in second and third trimester
Public title
The effect of education of sex behavior in the pregnant women's sexual function
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparus pregnant woman
Age: 18-35 years old
Healthy fetus
Single fetus
Having satisfaction
Exclusion criteria:
History of surgery in the external and Internal genitalia
History of chronic medical conditions (diabetes, heart, kidney, ...)
Taking medications other than folic acid and iron
Pelvic relaxation
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Random unit: Individual
Randomization Tool: Use Coin
50 pregnant women referred to pregnancy classes in Sayyad Shirazi Hospital were selected by convenience sampling and simple random assigned using coins in two groups.
The first group, in addition to routine pregnancy training, will receive sexual education during pregnancy and the second group will receive the same routine pregnancy training.
At the same time, 50 mothers among pregnant mothers referred to the prenatal clinic of Gorgan health centers were selected by convenience sampling and simple random assigned using coins in two groups. The first group will receive only sex education and the second group will not attend any class.
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 Golestan University of Medical Sciences
Street address
Road of Shastkolla, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2015-01-11, 1393/10/21
Ethics committee reference number
IR.GOUMS.REC.1393.25188169
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function
Timepoint
Before and after taking part in the educational class
Method of measurement
Sexual Function Questionnaire, FSFI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group will be participate in sexual behavior training class. this group have two sub group. Group 1: only participated in sexual behavior training class.
Category
Behavior
2
Description
Intervention Group will be participate in sexual behavior training class. this group have two sub group. Group2 : Participation in pregnancy classes in addition of sexual behavior training class.
Category
Behavior
3
Description
Control group have two sub group. Group 1: only participated in prenatal educational class and group
Category
Behavior
4
Description
Control group have two sub group. Group 2: who have not participated in any educational class.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital
Full name of responsible person
Fatemeh Seifi
Street address
Nursing & Midwifery Faculty, Golestan University of Medical Sciences, Road of Shastkollah
Nursing & Midwifery Faculty, Golestan University of Medical Sciences, Road of Shastkollah
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
f_seifi2016@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Road of Shastkollah Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Fax
+98 17 3242 1661
Email
f_seifi2016@yahoo.com
Web page address
http://fa.irct.ir/user/trial/31637/update/sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Seifi
Position
coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty., Golestan University of Medical Sciences., Beginning of the Road of Shasta Kalateh., 5th Km of Gorgan Kurdkuy Road
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
Fatemeh_seifi1979@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narjes Sadat Borghei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
borghei2006@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fateme Seifi
Position
coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
Fatemeh_seifi1979@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
Yes - There is 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
Not applicable
Title and more details about the data/document
the information on the main outcome or the like can be shared.
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
Data will be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
The data will be available for scientific research with reference to the research. In order to access the data, they can reply to the person's email address.