Protocol summary

Study aim
The main objective of the project: Determining the effectiveness of structured education on female sexual function in pregnancy
Design
Design: Randomized, Not blinded, placebo not used.Statistical population:Pregnant women referred to health centers in the city of Baharestan, Tehran province.Inclusion criteria: Pass at least 4 weeks after giving birth to the mother, Maximum gestational age 34 weeks. The exclusion criteria will be: There is a history of preterm labor, There is a history of cervical failure, The presence of Placenta Previa. The sample size included 80 patients.
Settings and conduct
The study population is pregnant women referring to health centers in Baharestan, Tehran province. To do this, at first, four centers of eight urban health centers and the days when a researcher in each center will be present to register pregnant women will be drawn in the draw. In each center, any pregnant woman entering the study is enrolled in the scheme. This will continue until the number of registered people reaches 20. This will be done in all four selected centers. Pregnant women complete the FSFI questionnaire in both control and intervention groups. This is a questionnaire on sexual feelings and responses in the last 4 weeks. In the intervention group, using a training package based on the content of the training, 4 groups will be trained during one week. 2 weeks after the completion of the sessions, the questionnaires will be completed again by the mothers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pass at least 4 weeks after giving birth to the mother; maximum gestational age 34 weeks; not having a history of abortion. The exclusion criteria will be: history of preterm labor; history of cervical failure; presence of placenta previa.
Intervention groups
Pregnant women complete the FSFI questionnaire in both control and intervention groups. This is a questionnaire on sexual feelings and responses in the last 4 week. In the intervention group, using a training package based on the content of the training, 4 sessions will be held within a week of group training. In the control group, training is also provided on the benefits of breastfeeding and normal delivery. Two weeks after the end of the sessions, the questionnaires are completed again by the mothers.
Main outcome variables
Expected outcomes: the results of this study suggest that structured education improves the sexual function of pregnant women, it is suggested that the knowledge gained be used to provide a functional training package in health centers and sexual health centers.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140907019077N14
Registration date: 2018-03-19, 1396/12/28
Registration timing: retrospective

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Sonia Oveisi
Name of organization / entity
Qazvin Unversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
soveisi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Structural Education on the Sexual Function of Pregnant Women Referred to Health Centers in Baharestan
Public title
The effectiveness of structured education on sexual function of pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Pass at least 4 weeks after giving birth to the mother Maximum gestational age 34 weeks
Exclusion criteria:
There is a history of preterm labor There is a history of cervical failure The presence of Placenta Previa
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects registered in this study are divided into two intervention and control groups by random allocation method. At this stage, using the Balanced Block Randomization method, the samples are divided into 5 blocks, which, depending on whether they are in block A or B, are placed in the intervention or control group.
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard,Qazvin
City
qazvin
Province
Qazvin
Postal code
59811-34197
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.QUMS.REC.1396.315

Health conditions studied

1

Description of health condition studied
Female sexual function during pregnancy
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 and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

Secondary outcomes

1

Description
Desire
Timepoint
Before and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

2

Description
Arousal
Timepoint
Before and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

3

Description
Lubrication
Timepoint
Before and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

4

Description
Orgasm
Timepoint
Before and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

5

Description
Satisfaction
Timepoint
Before and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

6

Description
Pain
Timepoint
Before and two weeks after intervention
Method of measurement
Female sexual function index questionnaire

Intervention groups

1

Description
Intervention group: First, the sexual performance questionnaire is completed by the mothers and their sexual function is measured. Then, participants participate in educational sessions based on the designed training package. The group training sessions are held within a week, which includes 4 sessions for 60 minutes. Two weeks after completing the training sessions, the sexual performance questionnaire will be completed by pregnant mothers.
Category
N/A

2

Description
Control group:First, the sexual performance questionnaire is completed by the mothers and their sexual function is measured. In this group, training is provided on the benefits of breastfeeding and normal delivery, and the sexual performance questionnaire is completed after two weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
valieasr health service center
Full name of responsible person
Mahnaz esmaili
Street address
Shahid Rajaee Square, Shahid Kouhpaee St.
City
Baharestan
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 5661 7036
Email
mhs_1924@yahoo.com

2

Recruitment center
Name of recruitment center
Golestan health service center
Full name of responsible person
Mahnaz esmaili
Street address
Second Golestan Square - opposite Husseinieh
City
Baharestan
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 5632 2443
Email
mhs_1924@yahoo.com

3

Recruitment center
Name of recruitment center
Ammar health service center
Full name of responsible person
Mahnaz esmaili
Street address
Sultan Abad-Shahid Chamran Avenue, Iran's Land Lab
City
Baharestan
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 5632 1412
Email
mhs_1924@yahoo.com

4

Recruitment center
Name of recruitment center
Sabzdasht health service center
Full name of responsible person
Mahnaz esmaili
Street address
Ferdows Avenue - next to Fadak Park
City
Baharestan
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 5633 1588
Email
mhs_1924@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
apeymani@qums.ac.ir
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 of Qazvin 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
Qazvin University Of Medical Sciences
Full name of responsible person
Mahnaz esmaili
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 21 5633 2239
Fax
Email
mhs_1924@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Sonia Oveisi
Position
Ph. D
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Fax
Email
soveisi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Mahnaz Esmaili
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Fax
Email
MHS_1924@YAHOO.COM
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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