assess the effectiveness of group sex and sexual health counseling on the satisfaction and sexual function of lactating women.
Design
Randomised,
A randomized, sham controlled clinical trial with a parallel group design of 90 patients, enrolled between and
Settings and conduct
Randomized clinical trial, Health centers in Yazd
Participants/Inclusion and exclusion criteria
Entry requirements:
Women who are nulliparous 18 years of age
Married Iranian Muslims whose first marriage is the sole wife of a person living side by side
Child is healthy, monogamous, terminated, is the result of natural birth and has exclusive breastfeeding
At least reading and writing skills
Have phones
Non-arrival conditions:
Rebirth
Unwanted pregnancy in the present delivery
Instrumental vaginal delivery
Grade 4 rupture during labor
Macrosomal neonate
Infant death, abnormalities and postpartum health problems
Presence of signs of postpartum depression
All diseases and Or drugs that affect the sexual function of couples
Drug addiction to each spouse
Their growth in a single parent
A history of any abnormal functioning and sexual abuse during pre-pregnancy
Genital surgery, hormonal dysfunction
Using hormonal contraceptive methods
Severe family disagreement Lady is lactating.
Intervention groups
Groups counseling
Telephone counseling
Main outcome variables
sexual satisfaction, sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035592N2
Registration date:2018-11-10, 1397/08/19
Registration timing:retrospective
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
samira haji maghsoudy
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3262 6921
Email address
samira.hm@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of sexual health counseling (group and telephone counseling) on sexual satisfaction and function in lactating women
Public title
The efficacy of sexual health counseling (group and telephone counseling) on sexual satisfaction and function in lactating women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women who are nulliparous 18 years of age
Married Iranian Muslims whose first marriage is the sole wife of a person living side by side
Child is healthy, monogamous, terminated, is the result of natural birth and has exclusive breastfeeding
At least reading and writing skills
Have phones
Exclusion criteria:
Rebirth
Unwanted pregnancy in the present delivery
Instrumental vaginal delivery
Grade 4 rupture during labor
Macrosomal neonate
Infant death, abnormalities and postpartum health problems
Presence of signs of postpartum depression
All diseases and Or drugs that affect the sexual function of couples
Drug addiction to each spouse
Their growth in a single parent
A history of any abnormal functioning and sexual abuse during pre-pregnancy
Genital surgery, hormonal dysfunction
Using hormonal contraceptive methods
Severe family disagreement Lady is lactating.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table, simple randomization was done individually.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Alem Sq., Safaieh Yazd Yazd Iran, Islamic Republic Of Yazd
City
Yazd
Province
Yazd
Postal code
8991768547
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.SSU.REC.1396-95
Health conditions studied
1
Description of health condition studied
Sexual satisfaction sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual satisfaction
Timepoint
Before the intervention, immediately and one month after the end of the intervention
Method of measurement
Larsson Sexual Satisfaction Questionnaire
Secondary outcomes
1
Description
sexual function
Timepoint
Before the intervention, immediately and one month after the end of the intervention
Method of measurement
Sexual Function Questionnaire (FSFI)
Intervention groups
1
Description
"Intervention group 1:" Five weekly counseling sessions
Category
Treatment - Other
2
Description
"Intervention group 2:" Five weekly phone calls
Category
Treatment - Other
3
Description
"Control group:" without intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Yazd
Full name of responsible person
Samira Haji Maghsoudy
Street address
Azad Shahr
City
Yazd
Province
Yazd
Postal code
8991768547
Phone
+98 35 3730 4630
Email
samira_hajimaghsoudy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaie
Street address
Shahid Sadoughi University of Medical Sciences, Alem Sq, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8991768547
Phone
+98 35 3262 6921
Email
Samira_hajimaghsoudy@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Samira Haji Maghsoudy
Position
A graduate student in midwifery advice
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Sadoughi University of Medical Sciences, Alem Sq, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8991768547
Phone
+98 35 3824 1751
Fax
Email
samira_hajimaghsoudy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahid Sadoughi University of Medical Sciences, Alem Sq., Safaieh Yazd
City
Yazd
Province
Yazd
Postal code
8991768547
Phone
+98 35 3824 1751
Fax
Email
mah_bokaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Samira Haji Maghsoudy
Position
A graduate student in midwifery advice
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Sadoughi University of Medical Sciences, Alem Sq., Safaieh Yazd
City
Yazd
Province
Yazd
Postal code
9891768547
Phone
+98 35 3824 1751
Fax
Email
samira_hajimaghsoudy@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
We will show all of the data.
When the data will become available and for how long
Get started 9 months after printing results
To whom data/document is available
All people are allowed.
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.