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A comparative study on the effect of face-to-face or group education during the pregnancy period and postpartum on sexual function of the couples

Protocol summary

Summary
Comparison of the effect of face to face education with group education on sexual function during pregnancy in couples was the purpose of this research, randomized, not blinded, No placebo controlled, multi center, phase trials does not apply in this study, Study population: all pregnant women and their husbands have medical family files (records) in the Isfahan health clinics, Isfahan, Iran, Inclusion criteria: Iranian nationality; Muslim; gestational age more than 20 weeks; women’s age under 40 years and men’s age around 50 years; Having informed consent to participate in the study. Exclusion criteria: history of medical diseases; consumption of the medication that affect sexual function; addiction in couples; having high risk pregnancy criteria; having experience of an acute stress during recent years such as child’s death, spousal treason; acute disease in any of the couples, postpartum depression; use of vacuum or forceps during delivery; birth trauma; birth weight babies over than 4000 gr; postpartum vaginal disorders; and infant mortality. Sample size: 64 couples in each study group (face-to-face education group and group education), Intervention time: during pregnancy, Primary outcome: demographic characteristics include: couple's age, couple's education, length of marriage, and number of pregnancies and children. Female and male Sexual Function Index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080518500N2
Registration date: 2015-07-06, 1394/04/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Maryam Mohammadi Mahdiabadzade
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1826 2498
Email address
maryammohamady@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-10, 1391/12/20
Expected recruitment end date
2014-04-14, 1393/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of face-to-face or group education during the pregnancy period and postpartum on sexual function of the couples
Public title
A comparative study on the effect of face-to-face or group education during the pregnancy period and postpartum
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Iranian nationality; couples’ being a Muslim; gestational age of over 20 weeks; women’s age under 40 years and men’s age around 50 years; signing a written consent form by the couples to attend the study; no history of medical diseases in couples; no consumption of the medication contraindicating with sexual function; no addiction to drugs in any of the couples; no high risk pregnancy; and no experience of an acute stress during recent years such as a child’s death, spousal treason; acute disease etc in any of the couples, Exclusion criteria; postpartum depression; The use of vacuum or forceps delivery; birth trauma; weighing more than 4000 gr at birth; postpartum vaginal disorders; infant mortality.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Isfahan University of Medical Sciences

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
392369

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
pre test, One month after the intervention and 10 weeks after delivery
Method of measurement
Female Sexual Function Index(FSFI) and Brief form of Sexual Function Inventory (BSFI)

Secondary outcomes

1

Description
A comparative study on the effect of face-to-face or group education
Timepoint
Before the intervention, after intervention, 10 weeks after delivery
Method of measurement
Female Sexual Function Index(FSFI) and Brief form of Sexual Function Inventory (BSFI)

Intervention groups

1

Description
Intervention "face-to-face education" In the face-to-face education group, education is conduct in a 90–120 min session through questions and answers and the educational issues, determine by the researcher for each couple with the help of an educational software and slide show, are conduct.
Category
Behavior

2

Description
Intervention "group education" In the group education group, the subjects are divide into three 10-13 subject groups and the education is conduct similar to face-to-face education group during a 120-min session.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirhamze Clinic
Full name of responsible person
Ms Godarzi
Street address
Amirhamze Clinic, Amirhamze, Isfahan
City
Isfahan

2

Recruitment center
Name of recruitment center
Navabsafavi Clinic
Full name of responsible person
Ms Tabatabae
Street address
Navabsafavi Clinic, Sq Ahmadabad, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Isfahan University of Medical Sciences Ashraf Kazemi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
11د
Grant code / Reference number
2350
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of
Full name of responsible person
Maryam Mohammadi Mahdiabadzade
Position
Msc
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3681 6512
Fax
Email
ba_zendegy@yahoo.com; maryammohamady@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of
Full name of responsible person
Maryam Mohammadi Mahdiabadzade
Position
Msc
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3681 6512
Fax
Email
ba_zendegy@yahoo.com; maryammohamady@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of
Full name of responsible person
Maryam Mohammadi Mahdiabadzade
Position
Msc
Other areas of specialty/work
Street address
243, Apartments ghazal, 15 Khordad street, Sq Mehrab, Yazd
City
Yazd
Postal code
8916815735
Phone
+98 35 3826 2498
Fax
Email
ba_zendegy@yahoo.com; maryammohamady@nm.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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