Protocol summary

Summary
This study aims to investigate the effectiveness of Sexual Enrichment Counseling Program On Sexual Satisfaction In Pregnant Women. Design: A randomized multy center non-blinded controlled trial. Setting and conduct: The overall aim and setting of the study are explained for eligible people. Samples will be allocated to intervention and control groups with the block size of 4 and informed consents are completed. The control group will receive routine cares.The intervention group will receive routine cares and participate in Sexual enrichment counseling program sessions. Sessions are held weekly. Inclusion criteria : low risk pregnant women in 14 _32 weeks without fetal anomaly ، no Psychological problems in couples، First marriage؛ Not having any of the spouses to alcohol and drugs ؛ no applying for divorce in court by 75 or less score by Larson s Sexual Satisfaction questionnaire that refer to medical care in Mashhad . exclusion criteria is no desire to continue participating in sessions and happening medical and obstetrical problem among sessions ؛ Target sample size is 60 pregnant women and intervention is Six two-hour sessions of in intervention group and Training routine prenatal care in control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022526757N1
Registration date: 2016-09-03, 1395/06/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-03, 1395/06/13
Registrant information
Name
Fateme Barvanloo Golmohamadi
Name of organization / entity
Shahroud University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
golmohammadi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-05-19, 1396/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Sexual Enrichment Counseling Program On Sexual Satisfaction In Pregnant Women.
Public title
Determine the effects of sexual enrichment program on sexual satisfaction in pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18 _ 35 years old low risk pregnant women in 14 _32 weeks without anomaly،no Psychological l problems in couples، no history of problem in past pregnancy as: abortion، fetal death، preterm labor and fetal anomaly ، no history of primary and secondary infertility؛ Singleton pregnancy؛couples First marriage؛ Not having any of the spouses to alcohol and drugs ؛ no applying for divorce in court. exclusion criteria: no desire to continue participating in sessions and happening medical and obstetrical problem among sessions.
Age
From 17 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences; TirSquare;Shahroud shahroud Semnan Iran, Islamic Republic Of 3614773955
City
Shahroud
Postal code
Approval date
2016-06-09, 1395/03/20
Ethics committee reference number
ir.shmu.rec.1395.39

Health conditions studied

1

Description of health condition studied
sexual satisfaction
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire

Primary outcomes

1

Description
sexual satisfaction
Timepoint
before and after intervention
Method of measurement
Larson s standard sexual satisfaction questionarie

Secondary outcomes

1

Description
Marital Satisfaction
Timepoint
before and after intervention
Method of measurement
Enrich marital standard questionnaire

Intervention groups

1

Description
intervention group: weekly Six two-hour sessions of Sexual enrichment counseling program in women have 75 or less score in Larson s sexual satisfaction questionnaire.
Category
Prevention

2

Description
In control group we have routine prenatal care.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical centers in Mashhad
Full name of responsible person
Dr Hamid Dastani
Street address
Mashhad , Razavi Khorasan Street koohsangi 14 Management of Social Security
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research; Medical Sciences of Shahroud University
Full name of responsible person
Dr Mohammad Hasan Emamian
Street address
Central building of Shahroud University of Medical Sciences،TirSquare، Shahroud، shahroud، Semnan ، Iran, Islamic Republic Of 009823 3614773955
City
shahroud
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; Medical Sciences of Shahroud University
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
of Shahroud University of Medical Sciences
Full name of responsible person
Fateme Barvanloo Golmohamadi
Position
Master student of midwifery counseling
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences، HafteTir Square، Shahroud، Shahroud، Semnan، Iran.
City
Shahroud
Postal code
Phone
+98 233614773955
Fax
Email
fatemegolmohamadi92@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Motaghi
Position
Phd
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences، HafteTir Square، Shahroud، Shahroud، Semnan، Iran.
City
Shahroud
Postal code
Phone
+98 233614773955
Fax
Email
zhrmotaghi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fateme Barvanloo Golmohamadi
Position
Master student of midwifery counseling
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences; HafteTir Square; Shahroud Shahroud Semnan
City
Shahroud
Postal code
Phone
+98 51 3864 6512
Fax
Email
fatemegolmohamadi92@gmail.comgolmohammadi@shmu.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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