Protocol summary

Summary
The purpose of this study is to examine the effect of educational program on maternal role attainment. A total of 100 pregnant women, 18 years of age and older, 36 WK and above, first- time mother with a singleton and uneventful pregnancy, without past psychiatric history are going to participate in this study. At first, all participants in the intervention group(n=50) and the control group (n=50) will be applied to complete questionnaires (Demographic Scale, Stress Scale, Maternal Identity Scale) after their informed consent about the research will be received. The expectant mothers in experimental group will take part in 3 educational sessions (a couple of sessions before and third session between 10 to 15 days after childbirth) and will be given 2 educational booklets and one CD.The education will be about different types of information about baby-care. This research is going to be conducted in two curative and health canters located in the southern region of Tehran that has similar socioeconomic situation. For prevention of exchanging educational information; the research will be conducted with control group in the curative and health center of Ayet and experimental group in the curative and health center of Aboozar. The participant will be excluded from the study in the case of fetal death or the death of baby and newborn anomalies or be quit of continuing in the study. All participants will complete questionnaires (Maternal Competence Scale, Stress Scale, and Maternal Identity Scale) at 6 and 12 weeks postpartum. The questionnaire of birthing and breastfeeding information will be completed at 12 weeks postpartum by all participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013060113542N1
Registration date: 2013-07-07, 1392/04/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-07, 1392/04/16
Registrant information
Name
Zohreh Khakbazan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 4339
Email address
khakbazanz871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-10-27, 1392/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on Maternal role Attainment and stress in the postpartum period among primiparous women
Public title
The effect of baby-care educational program on maternal role attainment among first-time mothers.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria in the research: Pregnant women ≥ 18 years old; Gestational age ≥ 36 weeks; Living with spouse; Singleton and uneventful pregnancy ; Healthy and without a past or family psychiatric history; No addiction to alcohol or drugs; With educational level of guidance school- registered or higher; Giving the informed consent to participate in the study Exclusion criteria from the study: To be quit of continuing in the research ; To consume drugs effecting on Nervous System; Happening of sudden unpleasant event or the death of close family member; Newborn anomalies like; Down’s syndrome &……………; The death of newborn or fetal death; Hospitalizing of newborn for jaundice &………….
Age
From 18 years old to 48 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of deputy of research Tehran University of Medical Sciences
Street address
6th Floor, Central Organization of Tehran University of Medical Sciences, Qods Ave, Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2013-05-16, 1392/02/26
Ethics committee reference number
130/282/د/92

Health conditions studied

1

Description of health condition studied
Maternal role attainment
ICD-10 code
F69
ICD-10 code description
Unspecified disorder of adult personality and behaviour

Primary outcomes

1

Description
Maternal Identity-Maternal Competence- Maternal Stress
Timepoint
Before intervention- 6 and 12 weeks Postpartum
Method of measurement
Maternal Identity Questionnaire-PARENTING SENSE OF COMPETENCE SCALE (PSOC)- stress questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The control group will receive routine cares alone.
Category
N/A

2

Description
The expectant mothers in experimental group will take part in 3 educational sessions (a couple of sessions before and third session between 10 to 15 days after childbirth) and will be given 2 educational booklets and one CD. The educational sessions will be held at least 60 minutes in the groups between 5 to minutes and the educational method is; lecture, demonstration, role playing and questioning. The educational content will be about different types of information about baby-care including; the care of cord, breastfeeding and its complications like breast schism, mastitis and about multivitamin drop, vaccination, baby bath, baby clothing, nutrition of infant and the care of urine-burn, fever, baby flatulence and…... The control group will receive routine cares alone.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Aboozar health center
Full name of responsible person
Forogh Abd Molayee
Street address
Fallah 30 meters, Aboozar Blvd, Navab Highway
City
Tehran

2

Recruitment center
Name of recruitment center
Shahid Ayat health center
Full name of responsible person
Arman Modarres
Street address
Against Shariati park, shariati ِDistrict, Mahan St, Behind Ghalaeh Morghi garrison
City
Tehran

3

Recruitment center
Name of recruitment center
ٍEmam Sadegh Health Center
Full name of responsible person
Hamid Talebi
Street address
No 32, Ahmadiyyeh District, Beheshti Ave, NematAbad Police Station
City
Tehran

4

Recruitment center
Name of recruitment center
NematAbad Health Center
Full name of responsible person
Fatemeh Shayegh
Street address
No3, Soheil St, Khlazyr Road, Saveh Road
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Yonesian
Street address
6th Floor.The central organization of Tehran University of Medical Sciences. Qods St.Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Name of organization / entity
Midwifery and Nursing Faculty of Tehran University of Medical Sciences
Full name of responsible person
Zohreh Khakbazan
Position
MSc and faculty member of Midwifery and Nursing of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Nosrat St. Tohid square.
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
khakbazanz871@mums.ac.ir
Web page address
fnm.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Midwifery and Nursing Faculty of Tehran Medical Sciences University
Full name of responsible person
Zohreh Khakbazan
Position
MSc and faculty member of Midwifery and Nursing Faculty of Tehran Medical Sciences University
Other areas of specialty/work
Street address
Nosrat St. Tohid Square.
City
Tehran
Postal code
1419733171
Phone
+98 21 8898 4339
Fax
+98 21 6690 4252
Email
khakbazanz871@mums.ac.ir
Web page address
fnm.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Midwifery and Nursing Faculty of Tehran University of Medical Sciences
Full name of responsible person
Shogra Jamshidbiki
Position
Bachelor/student
Other areas of specialty/work
Street address
Nosrat St.Tohid Square.
City
Tehran
Postal code
1419733171
Phone
+98 21 8840 5585
Fax
+98 21 6690 4252
Email
jamshidy2000@yahoo.com
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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