The effect of music therapy on breast milk secretion in premature infant mothers hospitalized in neonatal intensive care unit of Hazrat Zeinab (SA) Shiraz
The intervention study do in two stages for 4 days in two shifts, morning and afternoon.In this case, the amount of breast milk is measured with music and without music. Measuring the amount of milk will start from the third day after delivery.In the first phase and the fourth consecutive day, in two shifts, morning and afternoon mothers with the the standard of nursing care listening to instrumental music in 30 minutes(15 minutes before and 15 minutes during with breast milk by milkmaids). Immediately after the first stage do the second stage.In this case, the previous mothers fourth consecutive day do breast milk by milkmaids for 15 minutes without music.In the end, mean and variation in expressed breast milk can be compared in two stages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060628303N1
Registration date:2017-03-17, 1395/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-17, 1395/12/27
Registrant information
Name
Zeinab Zarei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4257
Email address
zezarei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Shiraz University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy on breast milk secretion in premature infant mothers hospitalized in neonatal intensive care unit of Hazrat Zeinab (SA) Shiraz
Public title
The effect of music therapy on breast milk secretion in premature infant mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the study: Mothers consent to participate in the study; Mothers of babies with a gestational age of 28 to 34 weeks; Do not use medications that decrease or increase the secretion of milk; The absence of severe hearing problems in mothers; Lack of substance abuse by the mother; No previous surgery on breast; Do not feed the baby through the breast; Lack of mental health problems in the mother
Exclusion criteria for the study: Not consent to continue cooperation mothers during the study; Discharge newborns during the study;The baby died during the study; Create problems in breast-fed during the study; use medications that decrease or increase the secretion of milk during the study; Create severe hearing problem in mothers during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For the same conditions of study for all the mothers in the study used a same milk vacum.befor study, Mothers will be trained to use the milkmaids.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences.Zand street,Shiraz
City
Shiraz
Postal code
713451978
Approval date
2016-11-06, 1395/08/16
Ethics committee reference number
IR.SUMS.REC.1395.141
Health conditions studied
1
Description of health condition studied
amount of secretion breast milk
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Premature infant mothers breast milk
Timepoint
15 minutes after intervention
Method of measurement
amount of milk according ml, use measure
Secondary outcomes
empty
Intervention groups
1
Description
Milk by milking,For 8 days and every day 2 times,4 days with music,4 The second day without music
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab (SA)
Full name of responsible person
Zeinab Zarei_nursing bachelor
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Research Department،Shiraz University of Medical Sciences
Street address
Seventh floor، Shiraz University of Medical Sciences،Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
University of Nursing and Midwifery Hazrate Fatemeh(SA) Shiraz
Full name of responsible person
Mitra Edraki
Position
Master neonates_Faculty member
Other areas of specialty/work
Street address
University of Nursing and Midwifery Hazrate Fatemeh(SA) Shiraz_Namazi Square
City
Shiraz
Postal code
713451978
Phone
+98 71 3647 4252
Fax
Email
vcrdep@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Nursing and Midwifery Hazrate Fatemeh(SA) Shiraz
Full name of responsible person
Sedighe Montaseri
Position
Master Infants_Faculty member
Other areas of specialty/work
Street address
Universityl of Nursing and Midwifery Hazrate Fatemeh(SA) Shiraz_Namazi Square
City
Shiraz
Postal code
713451978
Phone
+98 71 3647 4252
Fax
Email
montaseris@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Medical Sciences
Full name of responsible person
Zeinab Zarei
Position
Nursing bachelor
Other areas of specialty/work
Street address
Raajaei Hospital_Chamran Bolvar
City
Shiraz
Postal code
Phone
+98 71 3822 3926
Fax
Email
zezarei@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)