The effect of lullaby on Volume, fat, total protein and albumin of breast milk in mothers of premature infants admitted to neonatal intensive care unit.
The effect of lullaby on the volume, fat, total protein and albumin of breast milk in preterm neonatal mothers hospitalized in neonatal intensive care unit of Ayatollah Rohani
Design
A randomized controlled clinical trial with parallel groups, without blinding
Settings and conduct
The study population was mothers of premature infants hospitalized in the neonatal intensive care unit of Rohani hospital in Babol. and three groups of 30 in the first group on the first and sixth day of mother's milk sample, in the second group on the first day of the mother's milk sample and on the sixth day the sampling was repeated after listening to lullaby. In the third group, the mother was sampled on the first day after routine lactation training and listening to the lullaby for 30 minutes with the mother looking at her infant's picture, and again on the sixth day.
Participants/Inclusion and exclusion criteria
1) mother's willingness to participate in research 2) mother's breastfeeding 3) mother's ability to breastfeed at least once a day 4) intrauterine age 37-34 weeks 5) lack of anatomical problems in the breast such as nipple and fissure and mastitis 6) A physician's written instruction to allow breastfeeding by the mother 7) Not to have a previous pregnancy that may even lead to miscarriage.
Intervention groups
In this study we will have three groups:
Group 1) Routine breastfeeding training only
Group 2) Routine Breastfeeding Training with Lullaby for Mother,
Group 3) Routine breastfeeding training with lullaby voice for mother with baby photo of mother
Main outcome variables
The variables of this study are: breast milk volume, breast milk triglyceride, breast milk cholesterol, breast milk total protein, breast milk albumin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191114045439N1
Registration date:2020-01-14, 1398/10/24
Registration timing:prospective
Last update:2020-01-14, 1398/10/24
Update count:0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
Somayyeh Sefidhagi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 7506
Email address
s.sefidhaji@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lullaby on Volume, fat, total protein and albumin of breast milk in mothers of premature infants admitted to neonatal intensive care unit.
Public title
The effect of lullaby on Volume, fat, total protein and albumin of breast milk in mothers of premature infants admitted to neonatal intensive care unit.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
mother's willingness to participate in research
mother's breastfeeding
mother's ability to breastfeed at least once a day
intrauterine age 37-34 weeks
no anatomical problems in the breast such as nipple and fissure and mastitis
Written doctor's order that the mother be allowed to breast-feed
Not have a previous pregnancy that may even lead to abortion
Exclusion criteria:
1) mothers having cigarettes and addiction
2) use of drugs that affect milk production
3) active mothers with tuberculosis
4) mothers with AIDS
5) mothers who have undergone breast surgery
6) use Mothers who have hearing problems
7) using mothers who have postpartum depression or experiencing a life-threatening crisis
8) using mothers who are using nutritious ingredients
9) using mothers who have dietary and vegetable diets.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Given that the study population does not enter the study at the same time, and the researchers do not anticipate which group of individuals will belong to the study, randomization and hiding are used. To assign mothers of target group to one of three study groups (A, B and C), Block Randomization method is used, using random list generated by Random Allocation Software. Random will be put into opaque envelopes (concealment) until the assignment of people to groups is unpredictable.
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
National Ethics Committee on Biomedical Research
Street address
13th Floor, Block A, Headquarters of the Ministry of Health and Medical Education, , Iran Sima Ave, between South Flamak and Zarafshan, , Quds Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-11-09, 1398/08/18
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.217
Health conditions studied
1
Description of health condition studied
Volume, Fat, Total Protein, and Albumin of Breastfeeding Mothers Hospitalized in Neonatal Intensive Care Unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
breast milk volume
Timepoint
The first day of study and the sixth day of study in all three groups
Method of measurement
By the graduated container
2
Description
triglyceride
Timepoint
The first day of study and the sixth day of study in all three groups
Method of measurement
By spectrophotometer
3
Description
cholesterol
Timepoint
The first day of study and the sixth day of study in all three groups
Method of measurement
By spectrophotometer
4
Description
total protein
Timepoint
The first day of study and the sixth day of study in all three groups
Method of measurement
By spectrophotometer
5
Description
albumin
Timepoint
The first day of study and the sixth day of study in all three groups
Method of measurement
By spectrophotometer
Secondary outcomes
1
Description
We have no secondary consequence.
Timepoint
21/1/2020
Method of measurement
The volume of breast milk is measured by a graduated container in milliliters. Breast milk triglyceride, breast milk cholesterol, total breast milk protein and albumin were calculated by standard kit and UK Spectrophotometer (UNICO 9344) with a precision measurement of mg / dl.
Intervention groups
1
Description
Intervention group: A group that listens to lullaby with routine training.
Category
Other
2
Description
Intervention group: A group that looks at their pre-baby photo taken during lactation, in addition to listening to lullaby.