A clinical trial aimed at psychosocial factors such as self-awareness and knowledge and effective communication with the medical staff and its impact on breast-feeding mothers. The inclusion criteria: nulliparous pregnant women and having at least 18 years of age who have decided to breastfeed. Not having Systemic disease during pregnancy and postpartum psychosis and not having training and experience of breastfeeding. On the first day postpartum mothers participating in the study will be discussed with the consent and demographic data will be completed by the investigator. If there is any disease in the mother's ability to breastfeed her baby, or that influenced excluded from the study. 104 mothers will be randomly divided into two groups (52 interventions and 52 controls). Random segmentation method using a permutation. Before intervention will be provided efficacy questionnaire, STAI Edinburgh and to mothers. How and number lactation, each time breastfeeding, duration of breastfeeding, use of food aid, food aid, and the use of artificial milk to those will asked to mothers at baseline and at 6, 12, 18 and 24 months by delivery telephone follow-up procedure . Interventions including education of health care personnel relation with pregnant women, providing training package for information on parenting and education of mothers in relation to maternal efficacy immediately after the delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013123010746N3
Registration date:2014-01-04, 1392/10/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-04, 1392/10/14
Registrant information
Name
Nasrin Abedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
abedinia@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Tehran University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of acknowledgement and self-awareness on breastfeeding
Public title
Effectiveness of acknowledgement and self-awareness on breastfeeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:nulliparous pregnant women at least 18 years of age who have decided to breastfeed. None of the samples was not affected by systemic diseases during pregnancy.There is not history of postpartum psychosis and before they have not trianed breastfeeding. Not having any disease or defects in newborns and mothers having any disease that affects her ability to breastfeed. These cases will be excluded.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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 Tehran University of Medical Sciences
Street address
Research Qods St., Keshavarz Blvd Tehran University of Medical Sciences
City
Tehran
Postal code
Iran
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
22127
Health conditions studied
1
Description of health condition studied
anxiety and depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Increase breastfeeding
Timepoint
Baseline and at 6, 12, 18 and 24 months from delivery
Method of measurement
Breastfeeding self-efficacy questionnaire; Edinburgh Test; Test Spielberger Trait anxiety and trait STAI -
Secondary outcomes
1
Description
Increased efficacy
Timepoint
Baseline and at 6, 12, 18 and 24 months from delivery
Method of measurement
Efficacy Questionnaire
Intervention groups
1
Description
In the intervention group, including training of health care workers (nurses or midwife delivery) to communicate proper of mothers who have given birth to their baby recently. The psychologist will be made at least two group sessions. The training consisted of four 10 skills are life skills. Listed four skills associated with effective communication, stress management and anger is. With this training, it is expected that staff communicate better and more responsive with mothers. In addition they attend their mothers’ demands to encourage breastfeeding. Also in relation to mothers' parenting awareness training package will be provided and it is necessary will be held individual psychological counseling sessions. In relationship self-Efficacy, mothers will reach with breastfeeding education and counseling psychology.
Category
Behavior
2
Description
In the control group, only if required to contact mothers with telephone when they have problems and we do not abandon ethically.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal clinic Imam Khomeini hospital and Milad Hospital
Full name of responsible person
Street address
Prenatal clinic Imam Khomeini hospital and Milad Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Street address
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
Research Council of 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
Research Center of Maternal-Fetal and Neonatal
Full name of responsible person
Nasrin Abedinia
Position
MSc/ Researcher
Other areas of specialty/work
Street address
Asr Hospital, Imam Khomeini Hospital Maternal Fetal and Neonatal Research Center
City
Tehran
Postal code
Iran
Phone
+98 21 6119 2357
Fax
Email
Nasrin.Abedinia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc
Other areas of specialty/work
Street address
Asr Hospital, Imam Khomeini Hospital Maternal Fetal and Neonatal Research Center
City
Tehran
Postal code
Iran
Phone
+98 21 6119 2357
Fax
Email
Nasrin.Abedinia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Maternal Neonatal Fetal Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc
Other areas of specialty/work
Street address
Vali asr hospital, Imam Khomeini Complex
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)