The purpose of this study is to determine the effect of peer support on anxiety, self-esteem and postpartum depression in women who come to health centers in Tabriz. This study is a single-blind randomized controlled trial. Ten (10) centers with a high number of prenatal cares will be involved in this study.The initiation of sampling will be from busiest health center and will be continued to other centers until achieving to sample size. Clients who have inclusion criteria will get a phone call and invited to health centre. After explaining the study and completing the Edinburgh Depression Inventory, (100) persons, who earned 11 to 23 score and wanted to participate in the study, will be chosen. Two groups will be established randomly, control group and intervention group. The intervention group may access to routine care during pregnancy and postpartum, and additionally access to support from their peers. Demographic form will be completed at first, and questionnaires of anxiety, depression and self-esteem will be completed before intervention and after two months of delivery. Data analysis will be done with descriptive statistics and covariance analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202266582N7
Registration date:2012-04-11, 1391/01/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-11, 1391/01/23
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2012-04-18, 1391/01/30
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer support on anxiety, self-esteem and postpartum depression: a single blind randomized controled trial
Public title
Effect of peer support on anxiety, self-esteem and postpartum depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: score of 11 to 23 in the Edinburgh Inventory, Primiparous women in the last three months of pregnancy, lack of illnesses like diabetes, epilepsy, high blood pressure, anemia and hypothyroidism, not happening of adverse event in the six months before, not using of psychotropic drugs and not having diseases such as mental retardation, psychological disorders and psychosis. Exclusion criteria: no maternal desire to continue participating in the study, occurring of adverse event during the study, preterm delivery.
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical scienses
Street address
University of Medical Scienses and Health Services,Daneshgah street
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
911
Health conditions studied
1
Description of health condition studied
pstpartum depression
ICD-10 code
F53.0
ICD-10 code description
mild mental and behavioral disorders associated with the puerperium
2
Description of health condition studied
anxiety
ICD-10 code
F41.2
ICD-10 code description
mixed anxiety and depressive disorder
3
Description of health condition studied
self-steem
ICD-10 code
Z61.3
ICD-10 code description
Events resulting in loss of self-esteem in childhood
Primary outcomes
1
Description
postpartum depression
Timepoint
before intervention in the last trimester of pregnancy,after intervention in the second month after delivery
Method of measurement
Edinburgh Inventory
Secondary outcomes
1
Description
Anxiety
Timepoint
before intervention in the last trimester of pregnancy, after intervention in the second month after delivery
Method of measurement
Spielberger state and trait anxiety inventory
2
Description
self-esteem
Timepoint
before intervention in the last trimester of pregnancy, after intervention in the second month after delivery
Method of measurement
rosenberg self-esteem scale
Intervention groups
1
Description
A (intervention group): They will have access to phone call at least one time in a week lasts 10 minutes from selected peers for exchanging of experiences in pregnancy, delivery and problems related to postpartum .These phone calls will be begun from last trimester of pregnancy and will continue second month after delivery. Seventeen (17) peers will be selected among women, who usually come to health centers, that they recently have had delivery and successful breast feeding, and can read and write in Persian. Peers will be matched with pregnant mothers based on demographic characters. Peers will pass 4 hours training session and after that they will call mothers for exchanging their experiences in pregnancy, delivery and postpartum with new mothers. Also whenever mother wants, she can call to peer.
Category
Prevention
2
Description
B (control group): They will not receive any phone call. Only they have access to routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamieh Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Hakim nezami street
City
Tabriz
2
Recruitment center
Name of recruitment center
Molla Hassan Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
End of seghatoleslam street
City
Tabriz
3
Recruitment center
Name of recruitment center
Shahid Khanli Helth Center
Full name of responsible person
Rogayyeh Iraji
Street address
Mansur street
City
Tabriz
4
Recruitment center
Name of recruitment center
Gomtapeh Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Yeka Dokan
City
Tabriz
5
Recruitment center
Name of recruitment center
Seyyed Bavafa Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Monajem Street
City
Tabriz
6
Recruitment center
Name of recruitment center
Abuzar Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
End of Sarbaz Shahid Street
City
Tabriz
7
Recruitment center
Name of recruitment center
Sevome Khordad Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Azadi Street
City
Tabriz
8
Recruitment center
Name of recruitment center
Garamalek Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Garamalek Street
City
Tabriz
9
Recruitment center
Name of recruitment center
Shahid Chamran Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Akhmagieh Town
City
Tabriz
10
Recruitment center
Name of recruitment center
Shanb Ghazan Health Center
Full name of responsible person
Rogayyeh Iraji
Street address
Sento road
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences-Vice chancellor for research
Full name of responsible person
research service
Street address
Tabriz university of medical sciences-Vice chancellor for research
City
Tabriz
Grant name
Grant code / Reference number
85611
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences-Vice chancellor for research
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
nursing & midwifery faculty
Full name of responsible person
Mahin Kamalifard
Position
master of sciences/lecturer-academic member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, shariaty street
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)