Objective: Comparing effectiveness of two methods of ring band & nipple massage on successful breastfeeding among mothers with nipple problems. Design: Randomized controlled clinical trial. Method: It will be conducted in hospitals of Tabriz (Al- Zahra and Taleghani). The qualified individuals will randomly be allocated to three groups of 33 persons with blocks of 6 and 9. One of the members of research team who is not involved in sample selection, will determine random allocation sequence using the computer program. The closed opaque envelopes will be scored respectively and used to hide the allocation. Intervention will begin 0.5 and 3 hours after vaginal delivery and cesarean section respectively, after mothers’ physical stability. Mothers in the intervention groups will receive: 1 (ring bond at the base of nipple which obtained from condom brim), 2 (massage of nipple or Hoffman massage) and 3 as control group (receive nipple's shield as the routine method of maternity ward). The variables of main outcome: The number of infants’ breast feeding during 1, 7 and 15 days, the ratio of infants’ bounding and the frequency of adverse events in mother and infants will be measured at groups of study during 1 and 15 days after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512078170N9
Registration date:2016-03-13, 1394/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-22, 1394/12/03
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of two methods of ring band & nipple massage on successes of breastfeeding among mothers with nipple problems
Public title
Successful breastfeeding with inverted nipples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18-40; willingness of women to participate at study; ability to read and write Persian; infant birth weight between 2000 and 4000 gr; mothers with flat or inverted nipple problem; phone number for follow-up
Exclusion criteria:Using pumps; caps or any other devices to facilitate breastfeeding; mothers' infants with physiological; anatomical and other abnormalities no able to feed orally; history of physical and mental illness of the mother (epilepsy; gastrointestinal disorders; cardiovascular; kidney); having stressful accidents 1 month ago such as divorce; death of family members; using effective drugs during breastfeeding (to increase and decrease milk and hormones); presence of a disease or disorder affecting the attachment of the baby on mother
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
99
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 Tabriz University of Medical Sciences
Street address
Azadi st; Golgasht Street ; Tabriz University of Medical Sciences Research & Technology
City
Tabriz
Postal code
51665118
Approval date
2015-11-26, 1394/09/05
Ethics committee reference number
rec.1394/779
Health conditions studied
1
Description of health condition studied
Breast-feeding problems
ICD-10 code
92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
The number of infants’ breast-feeding
Timepoint
1, 7, 15
Method of measurement
Device for weight gain
2
Description
Comparing the number of infants’ breast-feeding during 1, 7 and 15 days at massage group
Timepoint
1 , 7 and 15
Method of measurement
Calculating the number of infants’ breast-feeding and device for weight gain
3
Description
Comparing the number of infants breast-feeding during 1, 7 and 15 days at 3 groups
Timepoint
1, 7 , 15
Method of measurement
Calculating the number of infants’ breast-feeding and device for weight gain
Secondary outcomes
1
Description
Mother-infant bounding
Timepoint
Day 1 and 15 after intervention
Method of measurement
Maternal-fetal bounding scale
2
Description
Determining the frequency of adverse events in mother and infant at groups of study
Timepoint
1-14 after intervention
Method of measurement
Self- designed check List
Intervention groups
1
Description
The first group of intervention will receive ring bond at the base of nipple which cut from condom brim for successful breast-feeding
Category
Prevention
2
Description
The second group of intervention will receive massage of nipple or Hoffman massage for successful breast-feeding
Category
Prevention
3
Description
The control group will receive nipple's shield as the routine method of maternity ward for successful breast-feeding
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Maryam Kahfroshan
Street address
South Artesh street
City
Tabriz
2
Recruitment center
Name of recruitment center
Shahid Khanly
Full name of responsible person
Afkham Fazel Fard
Street address
Shahid Khanly: Health Center of Supporting Breast-Feeding Mothers; Beheshti st
City
Tabriz
3
Recruitment center
Name of recruitment center
Talegani Hospital
Full name of responsible person
Shakiba Poor Asad
Street address
Rah Ahan st
City
Tabriz
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
Number 2; Third floor; Golgasht Street; Azadi Avenue; Central Construction; Research department; Tabriz Medical Science University; 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
Faculty of Nursing and Midwifery, Tabriz Medical Science University
Full name of responsible person
Jamileh Malakouti
Position
Academic member; Faculty of Nursing and Midwifery; Tabriz
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati St
City
Tabriz
Postal code
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
malakoutij@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tabriz Medical Science University
Full name of responsible person
Jamileh Malakouti
Position
Academic member of School of Nursing and Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati St
City
Tabriz
Postal code
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
malakoutij@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz Medical Science University
Full name of responsible person
Jamileh Malakouti
Position
Academic member of School of Nursing and Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariat St
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)