Evaluation of Breast Massage on the Mother's Need for support During Lactation and Successful Breastfeeding in Neonates born through Cesarean Section in the Selected Hospitals Affiliated to Shahid Beheshti University Medical Sciences 2019.
Definition of the effect of breast massage on the mother's need for support during lactation and the successful breastfeeding in neonates born through cesarean Section
Design
Clinical trials include an intervention group and a control group that are randomly assigned in parallel
Settings and conduct
The context of this study was to determine the effect of breast massage on successful lactation in mothers of cesarean section and their need for support during lactation in selected hospitals of Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
inclusion criteria
1.Single pregnancy
2.Maternal aged 18 to 35
3.Physical and mental illness is not based on mother's statement and file documentation
4.The gestational age is 37 to 41 weeks
5.There is no history of breast surgery, breast cancer, burn and scarring in the breast
6.There is not Prenatal illnesses, such as Gestational Diabetes(GDM), Preeclampsia, and viral diseases such as AIDS and Hepatitis.
7.There is not Prenatal abnormalities such as Placental abruption, Placenta Previa, heart and respiratory diseases.
exclusion criteria
1.severe hemorrhage during cesarean section
2.Uterine inertia and atony during cesarean section
3.use any drugs that Suppression lactation
4.The mother has no desire for breastfeeding to the baby.
5.The mother has no desire for to continue to intervene.
6.The neonates is transmitted to the neonatal unit
7. Apgar scores 1 and 5 minutes in neonates less than 7
Intervention groups
intervention group
performs oketani breast massage and examines the mother's need support during lactation and successful breastfeeding.
control group
receives routine care and examines the mother's need support during lactation and successful breastfeeding.
Main outcome variables
breast massage, mother's need support during lactation, breastfeeding, neonates, cesarean
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190129042542N1
Registration date:2019-05-13, 1398/02/23
Registration timing:registered_while_recruiting
Last update:2019-05-13, 1398/02/23
Update count:0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Maryam Mahdizadeh Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 2707
Email address
m.mahdizadeh.sh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Breast Massage on the Mother's Need for support During Lactation and Successful Breastfeeding in Neonates born through Cesarean Section in the Selected Hospitals Affiliated to Shahid Beheshti University Medical Sciences 2019.
Public title
Evaluation of Breast Massage on the Mother's Need for support During Lactation and Successful Breastfeeding in Neonates born through Cesarean Section in the Selected Hospitals Affiliated to Shahid Beheshti University Medical Sciences 2019.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy
Maternal aged 18 to 35
Physical and mental illness is not based on mother's statement and file documentation
The gestational age is 37 to 41 weeks
There is no history of breast surgery, breast cancer, burn and scarring in the breast
There is not Prenatal illnesses, such as Gestational Diabetes(GDM), Preeclampsia, and viral diseases such as AIDS and Hepatitis.
There is not Prenatal abnormalities such as Placental abruption, Placenta Previa, heart and respiratory diseases.
Exclusion criteria:
severe hemorrhage during cesarean section
Uterine inertia and atony during cesarean section
use any drugs that Suppression lactation
The mother has no desire for breastfeeding to the baby.
The mother has no desire for to continue to intervene.
The neonates is transmitted to the neonatal unit
Apgar scores 1 and 5 minutes in neonates less than 7
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
In this study, a suitable sampling method (selection among mothers of candidates for cesarean section) based on inclusion criteria, and random allocation in two groups of intervention and control by simple random method.
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 Shahid Beheshti University of Medical Sciences
Street address
in front of Shahid Rajaee Hospital,Intersection Hashemi Rafsanjani Hwy, Valiasr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.223
Health conditions studied
1
Description of health condition studied
Cesarean, Breast Massage, Lactation, Successful Breastfeeding, Neonates
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The first main variable in this study is successful breastfeeding
Timepoint
Time interval to measure the successful breast feeding variable, first breastfeeding and last one before discharge mother from hospital(22-28 hour after cesarean delivery).
Method of measurement
instrument to assess successful breastfeeding is IBFAT(Infant Breastfeeding Assessment Tool)
2
Description
The second main variable in this study is mother's need support during lactation.
Timepoint
Time interval to measure the mother's need support during lactation variable, first breastfeeding and last one before discharge mother from hospital(22-28 hour after cesarean delivery).
Method of measurement
instrument to assess mother's need support during lactation is LATCH(Breastfeeding Charting System and Documentation Tool).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oketani breast massage included eight manual techniques performed within 60 sec and repeated for 15-20 min. Levels 1-3 of the given therapy were associated with the detachment of the bottom of the breast from its pectoralis major muscle. Furthermore, levels 4-6 involved pulling the whole breast with two thumbs down and to both sides by both hands. Additionally, level 7 included rotating the breast gently clockwise with stretching of its base, and level 8 was about milking the breast in four different directionsroup. This massage is done in two steps; first step before cesarean and the second in recovery after cesarean.
Category
Prevention
2
Description
Control group: receive routine care for the mothers in the control group and review Successful breastfeeding and mother's need support during lactation by IBFAT and LATCH tools.This review is done in two steps; first step during first breastfeeding after cesarean delivery and the second during the last breastfeeding before mom's discharged (The interval is 22 to 28 hours after cesarean delivery).