This study aims to compare the effect of educational programs on prevention of postpartum depression. This is a quasi- experimental study using a two-team field trial . To prevent contamination of the control group with the intervention , The location of study will include two health care centers in Sanandaj , a center for educational intervention and the other as a control center, selected randomly . In this study 100 primiparous women with Edinburgh score 12 or less, a singleton healthy term baby and without having known history of mental illness, 10-14 days after delivery will be recruited. The women who will experience adverse events during the study or wish to withdraw from the study will be excluded . In the intervention group 100 primiparous women will be participated. An educational programs on postpartum depression in three sessions: 10-14 days, 6 and 8 weeks after delivery that will be lasted 20 minutes per session will be provided by the researcher for mothers individually and then booklets will be delivered to the mother to recall. The researcher will follow the mothers and remind them the educational materials every 15 days by the phone. Control group include 100 primiparous mothers who will receive the routine postpartum care in (10-14 days, 6 and 8 weeks) after delivery . The Edinburgh questionnaire will be completed by both of groups in 8 weeks and 3 months after delivery. The educational program’s effect will be measured by comparing the Edinburgh scores .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110163034N7
Registration date:2011-12-07, 1390/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-07, 1390/09/16
Registrant information
Name
Mansoureh Jamshidimanesh
Name of organization / entity
Iran University Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1811
Email address
delshad2@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, faculty of Nursing and MidwiferyTehran University of Medical Sciences
Expected recruitment start date
2011-10-22, 1390/07/30
Expected recruitment end date
2012-01-20, 1390/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program on postpartum depression in Primiparous Women
Public title
The effect of education on the prevention of postpartum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women who are able to read and write ; live with their husband; were pregnant naturally ; have singleton healthy term baby( infant) ; have Edinburgh score equal or less than 12 ; are without complications after delivery ; have no known history of psychiatric disorders in current and previous pregnancy.
Exclusion criteria:
Primiparous women who suffered during the study ; mothers who withdraw during the study
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
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 School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tohid SQ, East Nosrat Ave
City
Tehran
Postal code
Approval date
2011-08-13, 1390/05/22
Ethics committee reference number
130-791-د-90
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F53
ICD-10 code description
Mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
The Edinburgh postnatal depression scores
Timepoint
10-14 days after delivery (before intervention) - 8 weeks and 3 months after delivery
Method of measurement
The Edinburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individual educational program will be implemented by the researcher in 3 sessions of 20 minutes including: 10-14 days, 6 and 8 weeks after delivery. In the first session the mothers will be educated about post partum depression (definition, prevalence, symptoms, causes and practical solutions to deal with it,including :getting help from his wife and family - enough rest and sleep - good nutrition - exercise techniques, relaxation, and Infant massage ) then, a booklet, including discussed topics, delivered to recall the mothers and finally the mothers’ questions will be answered by the researcher. In the second (6 weeks) and third sessions (8 weeks), the educational program will include more complete explanation of postpartum depression and practical strategies to deal with it . The Edinburgh questionnaire will be completed at baseline, 10-14 days, 8 weeks and 3 months after delivery.
Category
Prevention
2
Description
In the intervention group, the researcher will remind the mothers about training tips by the phone every 15 days after starting the educational program, and then will answer to the mother’s questions. The researcher’s phone number will be given to the mothers in order to answer their questions.
Category
Prevention
3
Description
In control group:the mothers will receive routine post partum care in health care centers in 10-14 days, 6 and 8 weeks after delivery, the Edinburgh questionnaire will be completed at baseline, 14-10 days , then in 8 weeks and 3 months after delivery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghods urban Health care center
Full name of responsible person
Hoda Ghadimi
Street address
Ghods urban Health care center , Taleghani St., Sanandaj ,Kordestan ,Iran
City
Sanandaj
2
Recruitment center
Name of recruitment center
Nebovat Urban Health care center
Full name of responsible person
Soheila Daneshvar
Street address
Nebovat Urban Health care center , Ekbatan St.,Sanandaj , Kordestan , Iran
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Cheraghi
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences Tohid SQ East Nosrat Ave Tehran, Iran
City
Tehran
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,Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Jamshidimanesh
Position
MSc Midwifery, Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences , Tohid SQ , East Nosrat Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 2166927171222
Fax
Email
jamshidimanesh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Jamshidimanesh
Position
Midwifery, Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid SQ , East Nosrat Ave ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 2166927171222
Fax
Email
jamshidimanesh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)