The purpose of this study was determine effects of kangaroo mother care on level of bilirubin newborns after cesarean and satisfaction mothers from care after birth. The study is single blind. The samples were placed randomly in two groups control and intervention. The study population included mothers and infants from cesarean delivery admitted in the women surgical ward of Fatima Hospital in the City Miyandoab. Inclusion criteria newborns were term, cesarean delivery, and mothers criteria receive spinal anesthesia. If during study the newborns have respiratory distress or pathological jaundice will be excluded. Mother use antidepressants or drug, have a history prior experience kangaroo mother care, diabetes and hypertension will be excluded. The number of samples is fifty eight for each group. The intervention group infants received kangaroo mother care immediately after birth, and this act repeated at hours 7, 13 and 19 later days, and control group infants receive routine care. Bilirubin both groups of babies at birth, 24 hours, 36 hours and the fifth day after birth from the forehead with Billy Check control and will compared. Mother's both groups receive satisfaction questionnaire from care after birth on the discharge day from hospital (third day), and will compare. The intervention group mothers receive experience questionnaire from kangaroo mother care and will compare. Bilirubin levels considered in newborns as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506064617N12
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of kangaroo mother care on the level of bilirubin in the newborn after cesarean and maternal satisfaction from care after birth
Public title
Effects of kangaroo mother care on the level of bilirubin in the newborn after cesarean and maternal satisfaction from care after birth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria newborns: infants born by cesarean delivery with spinal anesthesia; neonates (37 to 40 weeks of gestation); the apgar score birth fifth minute above 7. Inclusion criteria mothers: mothers of term infants; literate mothers; mothers are alert and awake; mothers receive spinal anesthesia. Exclusion criteria newborns: during the study, infants with respiratory distress or other problems; If, after the arrival newborn to the study inclusion criteria was not been observed; the newborn discharge during the study with parents satisfaction; pathologic jaundice factors (incompatibilities ABO-RH) or aggravating factors (deficiency glucose six phosphate dehydrogenase); cephalohematoma or significant contusion; respiratory distress syndrome or any condition that prevents of the delivery of newborn to mother; having a baby's skin disease; congenital anomalies; life-threatening problems; newborn alcohol syndrome. Exclusion criteria mothers: if the mothers does not want continued the study; after random selection of mothers in the control group was insisted to be in the intervention group; use psychotropic antidepressants, cigarette or other drugs; having previous experience of kangaroo mother care, study or employment mother in the field of medical sciences; mother's skin disease; having diabetes or hypertension; mother received general anesthesia.
Age
From 1 day old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study will done with random selection. Assigned acts to the mothers will be done in admission time with use of number opaque sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research,Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
9775138947
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
TBZMED.REC.1394.342
Health conditions studied
1
Description of health condition studied
Kangaroo mother care
ICD-10 code
Z39.0
ICD-10 code description
Care and examination immediately after delivery
Primary outcomes
1
Description
The amount of bilirubin
Timepoint
Immediately after birth, 24 hours after birth, 36 hours after birth, 5 days after birth
Method of measurement
With using from Billy Check (K-J-8000 model, made in Chin)
Secondary outcomes
1
Description
Mothers satisfaction from care after birth
Timepoint
Mothers discharge day from hospital
Method of measurement
Questionnaire
2
Description
The mothers experience of kangaroo mother care
Timepoint
Mothers discharge day from hospital
Method of measurement
Questionnaire
Intervention groups
1
Description
The control group after mother exit of the operating room will be receive routine care in recovery room. Newborns baseline bilirubin will controlled through forehead skin after birth with Billy Check (K-J-8000 model, made in China). Twenty-four and thirty-six hours and fifth day after birth neonatal bilirubin will be control and recorded again.On the third day postpartum mothers' satisfaction will be measured through questionnaires
Category
Prevention
2
Description
The intervention group before mothers transfer to the operating room will be trained about kangaroo mother care for 30 minutes. Newborns baseline bilirubin will controlled through forehead skin after birth with Billy Check (K-J-8000 model, made in China). The this group babies will be placed between mother's breasts immediately after birth in the recovery room. With blanket will be kept warm and dry, and a hat will be placed on baby's head to prevent heat loss. Appropriate position will be given to mother with folding bed or pillows. Kangaroo mother care will continue for 30 minutes. This position will be continued time mother transfer to surgery ward. Kangaroo mother care will be continued in the ward after transfer three times a day, each time for 30 minutes at hours 7, 13 and 19 until discharge. Curtain will help to privacy during kangaroo mother care. The baby's bilirubin will be controlled with Billy Check from forehead skin at hours 24, 36 after birth and fifth day, and will be recorded. Two questionnaires will be giving to the mothers on the third day. Maternal satisfaction from postpartum care and their experiences of kangaroo care will be measured on the third day after birth
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Hospital
Full name of responsible person
Street address
Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Tabriz University of Medical Sciences
Full name of responsible person
Doctor Rashidi
Street address
Deputy of Research, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of 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
Tabriz University of Medical Sciences
Full name of responsible person
Seyyedrasooly Alehe
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
9775138947
Phone
+98 41 3479 6770
Fax
Email
seyyedrasooly@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jabraeili Mahnaz
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
9775138947
Phone
+98 41 3479 6770
Fax
Email
jebreilim@yahoo.com; Jabraeilim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khiry Ziba
Position
Master student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
9775138947
Phone
+98 41 3479 6770
Fax
Email
zibakhiy@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)