Goal: The comparison of oral sucrose, breastfeeding and combination method on decreasing the first infant immunization local pain in health centres of Tabriz-Iran in 2009. Study sample: 120 infant (under 3 month in age) referring to Tabriz Health centres. Intervention: this study involved 3 intervention groups and one control group. First, Infant pain controlled by using NIPS checklist, then randomly samples classified into four groups, 0.6 cc/kg sucrose 25% was given to first intervention group, in the second group infants were breastfeeded, duration of breastfeeding was based on the infant's reluctant. In the third group breastfeeding was done at first and then 0.6 cc/kg sucrose 25% was given. In control group there was no intervention. Two minutes after intervention vaccination was done, and then pain, crying duration and heart pulse number were controlled in 0, 5th and 10th minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802101864N1
Registration date:2010-09-21, 1389/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-21, 1389/06/30
Registrant information
Name
Mohammad Hassan Sahebihagh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 313 5837
Email address
sahebihagh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sceinces
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-08-22, 1388/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of oral sucrose , breastfeeding and combination method on decreasing the first injective vaccines local pain in infants
Public title
Effect of oral sucrose and breastfeeding on decreasing pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Infants were under 3 old months. 2. Infants were eligible for receiving first time injective vaccines. 3. Infants had no diseases. 4. Infants had acceptable weight (3-97 percentiles) 5. Infants' parents were satisfied to participate in research. 6. Infants didn't receive sweet food 30 minutes before vaccination. 7. Infants weren't born from diabetic mothers. 8. Infants didn't receive drugs before vaccination especially acetaminophen. 9. Infants were fullterm. 10. Infants weren't breastfeeded or received pacifier at least 30 minutes before vaccination. 11. Infants' mothers did not have any limitations for breastfeeding. 12. Infants' mothers didn't receive drugs. 13. Infants should have vaccination injection pain experiment. 14. Infants sould came to health center with their mothers. Exclusion criteria: 1 - Parents' non-tendency to take part in research process in every stage of study. 2– Breastfeeding from starting infants' monitoring until pain control in 10th minute in control and sucrose groups. 3 – Intensive and long crying which is caused by DPT vaccine, not by pain injection.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Vice Chancellor for researchr, No. 2 centeral building of Tabriz University of Medical Sciences, Daneshghah Ave.
City
Tabriz
Postal code
5166615731
Approval date
2009-06-01, 1388/03/11
Ethics committee reference number
2568/4/5
Health conditions studied
1
Description of health condition studied
Pain after first time vaccine injection
ICD-10 code
T88.1
ICD-10 code description
Other complications following immunization, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
pre-intervention, immediately after intervention, 5th and 10th minutes after intervention
Method of measurement
NIPS (Neonatal Infant Pain Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 0.6 cc/kg sucrose 25%
Category
Prevention
2
Description
Control group: no intervention.
Category
N/A
3
Description
Intervention group 3: at first breastfeeding was done and then 0.6 cc/kg sucrose 25% was given.
Category
Prevention
4
Description
Intervention group 2: infants were breastfeeded; duration of breastfeeding was based on the infant’s reluctant.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Eram and shahidan Ebrahimi Health Centers
Full name of responsible person
Mohamad Hasan Sahebihagh
Street address
Health Group, Nursing and midwifery Faculty, South Shariaty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Rashidi
Street address
Research Department, 3rd floor of 2nd central bulding of Tabriz university of Medical Sciences, Daneshghah Ave.
City
Tabriz
Grant name
-------
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mohamad Hasan Sahebihagh
Position
Master Science in Community Health Nursing and Nursing Management
Other areas of specialty/work
Street address
Health Group, Nursing and midwifery Faculty, South Shariaty
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
sahebihagh@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
Mohamad Hasan Sahebihagh
Position
Master Science in Community Health Nursing and Nursing Management
Other areas of specialty/work
Street address
Health Group, Nursing and midwifery Faculty, South Shariaty
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
sahebihagh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mohamad Hasan Sahebihagh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)