To determine the effect of women's sexual education on their sexual function during pregnancy and postpartum
Design
In this study, 150 pregnant women referred to Health Services Centers are randomly divided into two groups of 75; that in the intervention group, the training will be given by lecture method and the second group will be witnessed.
Settings and conduct
This study is a longitudinal clinical trial. 150 participants of the samples referred to health service centers in Rasht (75 participants in each groups), will be selected randomly (in different regions in terms of economic and social status).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian nationality; gestational age less than 14 weeks; women’s age under 45 years; Having informed consent to participate in the study; Lack of history of medical diseases; lack of consumption of the medication that affect sexual function; lack of drug addiction; lack of high risk pregnancy criteria; lack of experience of an acute stress during recent years such as child’s death, wife's betrayal, acute illness, etc.
Exclusion criteria: happening any problem during study.
Intervention groups
In the intervention group, women will be taught 90 minutes through lecture, question and answer method.
Main outcome variables
Changes in sexual function score; Change in sexual distress score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131207015697N2
Registration date:2018-09-21, 1397/06/30
Registration timing:prospective
Last update:2018-09-21, 1397/06/30
Update count:0
Registration date
2018-09-21, 1397/06/30
Registrant information
Name
Shiva Alizadeh
Name of organization / entity
Islamic Azad university of rasht
Country
Iran (Islamic Republic of)
Phone
+98 13 1422 2154
Email address
gelayolalizadeh@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Sexual Education on the Sexual Function of Pregnant Women and Postpartum Referring to Health Services Centers
Public title
The Effect of Sexual Education on the Sexual Function of Pregnant Women and Postpartum
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality; Gestational age less than 14 weeks; Women’s age under 45 years; Having informed consent to participate in the study; Lack of history of medical diseases; Lack of consumption of the medication that affect sexual function; Lack of drug addiction; Lack of high risk pregnancy criteria; Lack of experience of an acute stress during recent years such as child’s death, Wife's betrayal, Acute illness, etc.
Exclusion criteria:
Iranian nationality; Gestational age less than 14 weeks; Women’s age under 45 years; Having informed consent to participate in the study; Lack of history of medical diseases; Lack of consumption of the medication that affect sexual function; Lack of drug addiction; Lack of high risk pregnancy criteria; Lack of experience of an acute stress during recent years such as child’s death, Wife's betrayal, Acute illness, etc.
Age
To 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The city's health services centers will be selected randomly (in different parts of the city based on the economic and social status), in each region some of these centers will be used for intervention and others will be witnesses.
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 Guilan University of Medical Sciences
Street address
Shahid Siadati Street, Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
IR.GUMS.REC.1397.194
Health conditions studied
1
Description of health condition studied
Sexual Function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual function
Timepoint
Before intervention; At the beginning of each subsequent intervention; Four weeks after the last intervention
Method of measurement
FSFI Questionnaire
2
Description
Sexual Distress
Timepoint
Before intervention; At the beginning of each subsequent intervention; Four weeks after the last intervention
Method of measurement
Sexual Distress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Face-to-Face training is provided to pregnant women in five sessions -90 minute- through lecture, Question and Answer, PowerPoint training provided by the researcher.
Category
Behavior
2
Description
Control group: Just Routine care is done in control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Services Centers in Rasht
Full name of responsible person
Shiva Alizadeh
Street address
No 6, Mozhdeh building, Second Alleyway, Bayanii Street, Heshmat Intersection
City
Rasht
Province
Guilan
Postal code
4194644184
Phone
+98 13 3366 9930
Email
gelayolalizadeh@iaurasht.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Shadman Nemati
Street address
Shahid Siadati Street, Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Islamic Azad University
Full name of responsible person
Shiva Alizadeh
Position
Faculty Member and Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University Rasht Branch, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 133342081
Email
gelayolalizadeh@iaurasht.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hoorieh Shayegan
Position
Faculty Member and Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shargh Guilan Nursing and Midwifery Faculty, Langroud
City
Langroud
Province
Guilan
Postal code
4476166595
Phone
+98 13 4256 5059
Email
shayegan@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shiva Alizadeh
Position
Faculty Member and Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University Rasht Branch, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 133342081
Email
gelayolalizadeh@iaurasht.ac.ir
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
Yes - There is a plan to make this available
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
A report including An Introduction, Methodology, Results and Discussion
When the data will become available and for how long
Access Period 1 Months After Publication
To whom data/document is available
All Officials and Experts of the Ministry of Health and Medical Education
Under which criteria data/document could be used
The applicant's commitment to preserve of the authors' names of this research if it is used
From where data/document is obtainable
A formal application letter to the health department of Guilan University of Medical Sciences or email this letter to the liaison author of this research project, named Shiva Alizadeh and E-mail: gelayolalizadeh@yahoo.com
What processes are involved for a request to access data/document
A application letter must include the name of the applicant, used item, scientific title of the research project or article.