The aim of this study was to compare the effect of Kangaroo mother care (KMC) and conventional methods (CMC) of care on response to pain secondary to Hepatitis B vaccination. A total of 40 preterm neonates between 32-37 weeks of gestational age, who are clinically stable, were randomly assigned into 2 groups. During vaccination against hepatitis B, in the intervention group (20 newborns) received KMC and the control group (20 newborns) received CMC. Response to pain with oxygen saturation by pulsoxymetery, pulse rate with monitoring, duration of crying by timer and pain score by NIPS test were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104211162N17
Registration date:2011-06-10, 1390/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-10, 1390/03/20
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-03-12, 1387/12/22
Expected recruitment end date
2010-02-09, 1388/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Kangaroo mother care (KMC) and conventional methods (CMC) of care on response to pain second to Hepatitis B vaccination
Public title
Effect of Kangaroo mother care (KMC) and conventional methods (CMC) of care on response to pain second to Hepatitis B vaccination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: newborn between 32-37 weeks gestational age, normal general condition, no respiratory problems, Apgar score above 7 and without congenital malformation
Exclusion criteria: cardiac and respiratory problems, congenital anomalies, hemodynamic problems, infants treated with sedative or analgesic drugs and usage of narcotics or sedatives by mother
Age
From 2 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research of Mashhad University of Medical Sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
511/2364
Health conditions studied
1
Description of health condition studied
Kangroo mother care
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Vaccination
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Response to pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Oxygen saturation
Timepoint
From 2 min before to 3 min after intervention
Method of measurement
pulsoxymetery
2
Description
Heart rate
Timepoint
From 2 min before to 3 min after intervention
Method of measurement
Cardiac monitoring
3
Description
Crying duration
Timepoint
From 2 min before to 3 min after intervention
Method of measurement
timer
4
Description
respose to pain
Timepoint
From 2 min before to 3 min after intervention
Method of measurement
NIPS test
Secondary outcomes
empty
Intervention groups
1
Description
Kangroo mother care, During the vaccination, baby was laid as cuddling in own mother.
Category
Prevention
2
Description
lying baby in bed, During the vaccination in control group baby was laid on bed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Research Center of Mashhad University of Medical Sciences
Full name of responsible person
Dr Ashraf Mohammadzadeh
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Jalil Tavakol Afshari
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr. Ashraf Mohammadzadeh
Position
Neonatologist, Professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ashraf Mohammadzadeh
Position
Neonatologist, Professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 5121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ashraf mohammadzadeh
Position
Neonatologist, Professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)