This study is a double-blind clinical trial that was performed In order to compare the effect of oral glucose with breastfeeding on pain of vaccination in infants. The study population were 195 healthy infants aged 2, 4, or 6 months referred to health centers of Yasuj city to receive DPT vaccine. The infants were randomly allocated into three groups. In the first group, the infants received breastfeeding started two minutes before injection of DPT vaccine and continued until the completion of injection. The other group received 2 cc of 50 percent glucose, orally by syringe. Control group didn’t receive any intervention and stayed in the mother's arms. Children's behavioral responses were observed 5 seconds before to 15 seconds after the injection according to modified behavioral pain by two observers unaware of the type of intervention. The duration of crying in seconds was recorded until 3 minutes after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905124359N2
Registration date:2010-09-01, 1389/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-01, 1389/06/10
Registrant information
Name
Leila Nikrooz
Name of organization / entity
Yasouj Univercity Medical Siencese
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 4115
Email address
l-nikrooz@yums.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2005-06-20, 1384/03/30
Expected recruitment end date
2005-08-11, 1384/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of the breastfeeding and sugar water on vaccination pain in infants
Public title
Comparing the effect of the breastfeeding and sugar water on vaccination pain in infants
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: being healthy, age 2, 4, 6 months, breastfed
Exclusion criteria: having a crying grade 3, receiving analgesic 48 hours prior to the intervention, receiving nutrition 30 minutes prior to the intervention, having a history of surgery, having a chronic disorder
Age
From 2 years old to 6 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
195
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondi Shapur University of Medical Sciences,
Street address
Golestan, Ahwaz
City
Ahwaz
Postal code
Approval date
2005-06-18, 1384/03/28
Ethics committee reference number
2387/20/8/پ
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52, Y60.3
ICD-10 code description
Acute pain, During injection or immunization
Primary outcomes
1
Description
Behavioral pain responses
Timepoint
5 seconds before injection until 15 seconds after injection
Method of measurement
Modifed Behavior Pain Scale
Secondary outcomes
1
Description
Duration of crying
Timepoint
Start of injection to calm down infants up to 3 minutes after injection
Method of measurement
cornometr
Intervention groups
1
Description
Breast feeding starting and continued until the injection
Category
Prevention
2
Description
No intervention, infants kept in the mother’s arm
Category
N/A
3
Description
Glucose, 50%, 2 cc, orally 2 minutes before DPT vaccination
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Yasuj
Full name of responsible person
Street address
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondi Shapur University of Medical Sciences,
Full name of responsible person
Shahnaz rostami
Street address
Golestan, Ahwaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jondi Shapur 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
Yasuj Univercity of Medical Sience
Full name of responsible person
Leila Nikrooz
Position
Faculty member,
Other areas of specialty/work
Street address
Nursing and midwifery faculty, Next to Imam Sajjad Hospital, Yasuj
City
Yasuj
Postal code
Phone
+98 74 1223 4115
Fax
Email
lnikrooz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Shahnaz Rostami
Position
Master of Nursing faculty member, Ahwaz University of Medical Sciences Professor
Other areas of specialty/work
Street address
Golestan, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 1338 0393
Fax
Email
shanaz_n00@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Leila Nikrooz
Position
Faculty mentor
Other areas of specialty/work
Street address
City
Yasuj
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)