Healthy neonates routinely are undergoing painful minor procedures. The aim of this study was to explore the effect of breastfeeding and pain relief in full-term neonates during injection of hepatitis B vaccination.
This was a randomized clinical trial. A sample of full-term neonates were randomly allocated into two groups: the experimental group (group 1) and the control (group 2). Neonates in the experimental group were breastfed two minutes before, during, and after the hepatitis B immunization and group 2 were held in mothers’ arms but not fed. Pain was assessed using the Douler Aigue Nouveaune (DAN) scale measuring facial expressions, limb movements and vocal expressions. The assessments were carried out after hepatitis B immunization.
Criteria for inclusion were: full- term neonate; had APGAR scores 7 higher at five minutes after birth; delivered by spontaneous and vaginal delivery; were breastfed; postnatal age not more than 24 hours. We excluded infants with any evidence of congenital abnormalities, medical complications, or drug exposure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104166206N1
Registration date:2011-04-26, 1390/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Parvin Rahnama
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8587
Email address
prahnama@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-11-12, 1386/08/21
Expected recruitment end date
2008-03-29, 1387/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breastfeeding on pain relief in full-term neonates during B vaccination
Public title
The effect of breastfeeding on pain relief in newborns during vaccination
Purpose
Prevention
Inclusion/Exclusion criteria
Criteria for inclusion were: full- term neonate; had APGAR scores 7 higher at five minutes after birth; delivered by spontaneous and vaginal delivery; were breastfed; postnatal age not more than 24 hours. We excluded infants with any evidence of congenital abnormalities, medical complications, or drug exposure.
Age
To 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences.
Street address
Ghods St, Keshavarz Blv, Tehran University of Medical Sciences
In the intervention group: Participating neonates and their mothers were taken to a quiet nursery room for immunization. The study did not start until the infant was observed to be sucking at the breast. Effective sucking movements were defined as movements in which the sucking sufficiently moved the temporomandibular joints to allow the infant to obtain maternal milk and eventually swallow it. This usually required 30-60 seconds to achieve. None of the infants had been breastfed for at least 30 minutes before the study procedures commenced. In experimental group, feeding was begun two minutes before, during, and after hepatitis B vaccination (n=65). At the end of the second minute of breastfeeding, while the infants were still sucking, the immunization injections were performed.
Category
Prevention
2
Description
In the control group: neonates were not breastfed but held by the mother for the same length of time at the experimental group. In the controls experienced the same procedure while were held in mothers arms but not fed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirzakochak Khan ( women hospital)
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
Ghods St, Keshavarz Blv,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of 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
Shahed University
Full name of responsible person
Parvin Rahnama
Position
Assistant professor
Other areas of specialty/work
Street address
Enghelab Sq, Kargar St, Shahed University
City
Tehran
Postal code
Phone
+98 21 4482 2258
Fax
Email
p_rahnama1381@yahoo.com; prahnama@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
faculty of nursing and midwifery,Tehran University of Medical Sciences
Full name of responsible person
Maryam Modarres
Position
Instructor,MSc
Other areas of specialty/work
Street address
Tohid Sq, Nosrat St., Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2252 1485
Fax
Email
ma_modars@yaho.com; modarres@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Parvin Rahnama
Position
assistant professor/Ph.D
Other areas of specialty/work
Street address
North Kargar, Enghelab Sq. Shahed University
City
Teharan
Postal code
1417653761
Phone
+98 21 4482 2258
Fax
Email
p_rahnama1381@yahoo.com; prahnama@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)