Objectives: Comparison of the efficacy of breastfeeding babies in NICU nurse's support in the training and routine methods. Design: Randomized, single-blind, single-center, phase II clinical trial. Performance: For group A nursing support training method is done. For group B the routine procedure is done. After training, self-efficacy is evaluated. The main conditions entry and departure of participants: Inclusion criteria: nulliparous mothers who have childbirth during the last week, their infants, the baby reached the top 37 completed weeks. Exclusion criteria: Dissatisfaction mother, physician order because of not to breast feeding. Interventions: For group A nursing support training method is done. For group B the routine procedure is done. The main outcome variables: Self breastfeeding
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071913691N8
Registration date:2017-03-24, 1396/01/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-24, 1396/01/04
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nursing protection education for breast feeding on self-efficacy
Public title
Effect of nursing protection education for breast feeding on self-efficacy in mothers with newborns admitted to the neonatal unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous mothers who have childbirth during the last week; their infants; the baby reached the top 37 completed weeks. Exclusion criteria: Dissatisfaction mother; physician order because of not to breast feeding.
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, City University, Tabriz
City
Tabriz
Postal code
Approval date
2017-02-20, 1395/12/02
Ethics committee reference number
IR.TBZMED.REC.1395.1257
Health conditions studied
1
Description of health condition studied
Self Efficacy
ICD-10 code
P92.9
ICD-10 code description
Feeding problem of newborn, unspecified
Primary outcomes
1
Description
Breastfeeding self-efficacy
Timepoint
Pre intervention- Post Intervention
Method of measurement
Breast Feeding Self Efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Breast feeding Education
Category
Treatment - Other
2
Description
Breast feeding in routin method
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hadis Asadi
Street address
Imam Khomeini Hospitalو Shahid Chamran Ave
City
West Islam Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Arshadi Bostanabad
Position
Academic Member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty-Sharyati Ave
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
arshadi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arshadi Bostanabad Mohammad
Position
Assistant Professor
Other areas of specialty/work
Street address
South Sharyati Ave-Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
arshadi_m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Arshadi Bostanabad
Position
PhD in Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty- South Sharyati Ave
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
arshadi@tbzmed.ac.ir; arshadi_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)