The aim of this study is to evaluate the effect of couples counseling based on post partum depression after baby's birth . A sample size is of 84 pregnant women and their husbands. 84 pregnant women referred to health centers will be randomly selected, and then will be divided into two intervention and control groups randomly. For the intervention group counseling session from 34 weeks of pregnancy will be held. The number of counseling sessions are 4 sessions. In the control group no intervention will be done. Two months after childbirth, postpartum depression in intervention and control groups will be measured by using a questionnaire Edinburgh. Inclusion criteria: gestational age of 34 weeks and nulliparity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060828340N1
Registration date:2016-12-17, 1395/09/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-17, 1395/09/27
Registrant information
Name
Atefeh Yas
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
yas.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research of University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of couple counseling based on couples post partum depression
Public title
post partum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for womens: Nullipar of; Pre-test score of less than 9; The absence of abnormalities in the fetus; Gestational age of 34 weeks; Lack of depression known; Failure stressful event in the past 6 months
Inclusion criteria for men :Lack of drug addiction; have a job; Lack of depression known
Exclusion criteria:Non-attending counseling; Abnormalities in the baby or infant death; Maternal and child needs special care after birth
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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 the University of Medical Sciences
Street address
Street Jahad ،Urmia
City
Urmia
Postal code
Approval date
2016-06-10, 1395/03/21
Ethics committee reference number
IR.UMSU.rec.1395.102
Health conditions studied
1
Description of health condition studied
postpartum deprassion
ICD-10 code
f53
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
postpartum deprassion
Timepoint
Before and four months after the intervention.
Method of measurement
Edinburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will participate in counseling sessions.The meetings will be held with the participation of couples in four sessions
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers
Full name of responsible person
Street address
City
uromia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Assistance for Research and Technology of Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Jahad street
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistance for Research and Technology of Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Soheila Rabeepoor
Position
faculty member
Other areas of specialty/work
Street address
Jahad Street
City
Urmia
Postal code
Phone
+98 44 3275 4963
Fax
Email
soheila80@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Atefeh Yas
Position
Masters student
Other areas of specialty/work
Street address
Zaker Street
City
Urmia
Postal code
Phone
+98 442754963
Fax
Email
atefehyas@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Atefeh Yas
Position
Masters student
Other areas of specialty/work
Street address
Zaker Street
City
Urmia
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)