The purpose of this study was to assess the effect of kangaroo mother care on pain intensity of heel lance in preterm newborns admitted to neonatal intensive care units.
in this cross over research, 64 vitally stable preterm infants between 30- 36 week gestational age admitted to neonatal intensive care units of Arash and Valiasr Hospitals affiliated to Tehran University of Medical Sciences and had need atleast two heal lance were randomly divided into two groups. In group A for the first heel lancing, infants recieved kangaroo care 15 minutes before the procedure. In group B, 15 minutes before lanceting, infants were kept in prone position, in incubator. For second heel lancing , the infants in group A were put in incubator, and group B received kangaroo care. Premature Infant pain profile (PIPP) were scored during and within 2 minutes after finishing the procedure in both conditions and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030412702N1
Registration date:2013-10-28, 1392/08/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-28, 1392/08/06
Registrant information
Name
Maliheh Javidpour
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 2527 8276
Email address
javidpour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-23, 1391/04/03
Expected recruitment end date
2012-10-14, 1391/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Kangaroo mother care on pain from heel lance in preterm newborns admitted to neonatal intensive care unit
Public title
The effect of Kangaroo care on pain in preterm newborns
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: were newborns with gestational age of 30 -36 weeks; within 3 - 14 days of birth; breathing unassisted; did not have any congenital anomalies and central nervous system diseases; had not undergone surgery; and were not receiving paralytic; analgesic; or sedative medications within 48 hours; Mothers had to be willing and able to hold their infant in the KMC position for the study.
Exclusion criteria: declining the mother from participation; discharging from the hospital before second heel lancing with written informed consent.
Age
From 30 years old to 36 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Gods Ave, Tehran
City
Tehran
Postal code
-
Approval date
2012-05-24, 1391/03/04
Ethics committee reference number
175/130/د/91
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
pain from heel lance
Timepoint
before, during and 2 minutes after the lancing
Method of measurement
PIPP was used
Secondary outcomes
empty
Intervention groups
1
Description
Kangaroo mother care position. In the Kangaroo mother care position, 15 minutes before, during and 2 minutes after the heel lancing, diaper-clad infant, was held upright, in skin to skin contact with their mother under her gown and between her breasts and a blanket were placed over the infant's back.
Category
Prevention
2
Description
In incubator. In incubator condition, newborn were placed in the incubator in a prone position and swaddled with a blanket 15 minutes before, during and 2 minutes after the heel lancing.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Javidpour Maliheh
Street address
Rashid Ave, Tehranpars, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Javidpour Maliheh
Street address
Tohid Ave, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rahmati Maryam
Street address
Faculty of Nursing and Midwifery, Tohid Av, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Emdadi Hospital
Full name of responsible person
Javidpour Maliheh
Position
MSC in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Khoramshahr Blvd, Abhar
City
Abhar
Postal code
4561915911
Phone
+98 24 2527 7741
Fax
-
Email
mjavidpour5@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mosayebi Ziba
Position
Neonatologist
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
-
Phone
+98 21 6691 7648
Fax
-
Email
mosayebiir@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Javidpour Maliheh
Position
Master Degree of Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Emdadi Hospital, Khoramshahr blvd, Abhar
City
Abhar
Postal code
4561915911
Phone
+98 24 2527 8276
Fax
-
Email
mjavidpour5@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)