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IRCT20191114045439N1 IRCT 2020-01-14 Vice chancellor for research, Babol University of Medical Sciences 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 Volume, fat, total protein and albumin of breast milk in mothers of premature infants admitted to neonatal intensive care unit. 2020-01-21 anticipated 90 Complete https://irct.ir/trial/43671 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Volume, Fat, Total Protein, and Albumin of Breastfeeding Mothers Hospitalized in Neonatal Intensive Care Unit. Intervention 1: Intervention group: A group that listens to lullaby with routine training. Intervention 2: Intervention group: A group that looks at their pre-baby photo taken during lactation, in addition to listening to lullaby. Intervention 3: Control group: Who receive only routine training. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Somayyeh Sefidhagi
Babol Medical University
Babol Iran (Islamic Republic of) 4717641367 +98 11 3233 7506 s.sefidhaji@mubabol.ac.ir Babol University of Medical Sciences scientific Somayyeh Sefidhagi
Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4717641367 +98 11 3223 8301 sshagi1362@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Female 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. Other Other Other Intervention group: A group that listens to lullaby with routine training. Intervention group: A group that looks at their pre-baby photo taken during lactation, in addition to listening to lullaby. Control group: Who receive only routine training. 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. Triglyceride. Timepoint: The first day of study and the sixth day of study in all three groups. Method of measurement: By spectrophotometer. Cholesterol. Timepoint: The first day of study and the sixth day of study in all three groups. Method of measurement: By spectrophotometer. Total protein. Timepoint: The first day of study and the sixth day of study in all three groups. Method of measurement: By spectrophotometer. Albumin. Timepoint: The first day of study and the sixth day of study in all three groups. Method of measurement: By spectrophotometer. 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. Vice chancellor for research, Babol University of Medical Sciences Approved 2019-11-09 National Ethics Committee on Biomedical Research 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 Tehran Tehran Iran (Islamic Republic of)