To determine the impact of Psychological counseling on the sexual intimacy of lactating women.
Design
Clinical trial with control group, intervention, simple randomization, 32 persons under consultation and 32 persons in control group
Settings and conduct
Of the eight Rafsanjan urban clinics, four health centers will be selected randomly and then will be divided into two centers intervention and two centers control. From both intervention and control groups the pre-test questionnaire will be taken. Subsequently,Psychological counseling will be given to the intervention group. Four weeks after the last counseling session, both groups will receive post-test.
Participants/Inclusion and exclusion criteria
Entry requirements: women with firs childbearing, 3-6 months after childbirth.
Conditions of non-arrival: postpartum depression, chronic mental and physical disease history, couples' addiction and smoking, previous presence in sex education classes, pregnancy, losing a baby, being away from marriage, severe marital conflicts and adverse events.
Intervention groups
The intervention group receive several Psychological counseling .
The control group does not receive any counseling.
Main outcome variables
Sexual intimacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151103024866N12
Registration date:2018-11-09, 1397/08/18
Registration timing:retrospective
Last update:2018-11-09, 1397/08/18
Update count:0
Registration date
2018-11-09, 1397/08/18
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-23, 1397/02/03
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of group psycho educational counseling on the sexual intimacy of lactating women who refer to health centers in Rafsanjan
Public title
Investigate the effect of group psycho educational counseling on the sexual intimacy of lactating women who refer to health centers in Rafsanjan
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Period of 3 to 6 months after childbirth
Primiparous women
Exclusion criteria:
Not having postpartum depression
Not having history of mental and physical illness (diabetes, kidney problems, heart problems ..)
Use breast milk
Non-addicted couples
Lack of previous sex education classes
The desire to attend all meetings
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Kerman University of Medical Sciences Ethics committee
Street address
campus University beginning around sevsn gardens alavi؛ kerman
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-12-27, 1396/10/06
Ethics committee reference number
ir.kmu.rec.96000195
Health conditions studied
1
Description of health condition studied
The sexual intimacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual intimacy score in the Bagarozzi questionnaire
Timepoint
Before the consultation and Four weeks after intervention
Method of measurement
Sexual intimacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This interventional study was carried out in the statistical society of lactating women referring to health centers in Rafsanjan in 1397. In this study, firstly, after obtaining informed written consent from women, 70 women with first delivery and lactating will be selected in an easy sampling. Of the eight Rafsanjan urban clinics, four health centers will be selected randomly and then divided into two centers intervention and two centers control. The intervention consists of 6 sessions of one-hour counseling with a sequence of one week each session for intervention group in groups of five to ten people. Initially, from both groups intervention and control the pre-test questionnaire were taken. Subsequently, psychiatric counseling was given to the intervention group. Four weeks after the last counseling session, both groups received post-test. In order to prevent the control group from learning the contents and distort the results, the control and intervention groups are selected from separate health centers. Also, in order to be more confident, the intervention group is asked to not talk with other people during the training course on the educational content, except with their spouse.
Category
Behavior
2
Description
Control group: No intervention will be received and only completes the questionnaire.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Health center
Full name of responsible person
Zahra Akbari Nejad
Street address
Imam street
City
Rafsanjan
Province
Kerman
Postal code
7717863938
Phone
+98 34 3432 9363
Email
alidoosti@kmu.ac.ir
2
Recruitment center
Name of recruitment center
Imam Sadiq Health Center
Full name of responsible person
Zahra Akbari Nejad
Street address
Worker Street
City
Rafsanjan
Province
Kerman
Postal code
7717863938
Phone
+98 34 3432 9363
Email
alidoosti@kmu.ac.ir
3
Recruitment center
Name of recruitment center
Health Center No. 7
Full name of responsible person
Zahra Akbari Nejad
Street address
Shahid Shafiei Street
City
Rafsanjan
Province
Kerman
Postal code
7717863938
Phone
+98 34 3432 9363
Email
alidoosti@kmu.ac.ir
4
Recruitment center
Name of recruitment center
Health Center No. 4
Full name of responsible person
Zahra Akbari Nejad
Street address
Amir Kabir Street
City
Rafsanjan
Province
Kerman
Postal code
7717863938
Phone
+98 34 3432 9363
Email
alidoosti@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research kerman university of medical sciences
Full name of responsible person
Dr.Abbas pardakhti
Street address
Campus university of medical sciences beginning around seven gardens alavi؛ kerman
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
kmu_research@yahoo.com
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 kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zahra Akbari Nejad
Position
Master of Midwifery Consultation
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Razin Faculty of Nursing and Midwifery
City
Kerman
Province
Kerman
Postal code
7717863938
Phone
+98 34 3432 9363
Fax
+98 34 3132 5218
Email
zakbari468@yahoo.com
Web page address
http://kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
kobra Alidoosti
Position
Master Degree
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
kerman University of Nursing and Midwifery Razi
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
alidoosti@kmu.ac.ir
Web page address
http://kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Akbari Nejad
Position
Master of Midwifery Consultation
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
kerman University of Nursing and Midwifery Razi
City
kerman
Province
Kerman
Postal code
7717863938
Phone
+98 34 3432 9363
Fax
+98 76 1691 3555
Email
zakbari468@yahoo.com
Web page address
http://kmu.ac.ir
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