Pain response in infants is higher than adults. Therefore, applying methods of pain control by health team members is essential. Vaccination is one of the most painful events during infancy that often is done without pain management. The purpose of this study is to compare the effect of EMLA cream with rattles on reducing immunization pain in infants of four months. This study is a randomized clinical trial which will be conducted on 50 healthy infants referred to health centers for DTP vaccine in Gonabad, Iran. The will be randomly assigned to three groups as EMLA cream, rattles and control. Control group of infants will be placed in the blankets on the bed to be injected as usual. Researcher will shake rattles from 30 seconds before until 15 seconds after injection of the vaccine for rattles group of infants. For EMELA group, 2 g of EMLA cream will be applied in place of vaccine. After an hour, infant pain questionnaire will be completed before, during and after vaccination of infants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207153150N3
Registration date:2012-09-29, 1391/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-29, 1391/07/08
Registrant information
Name
Mahdi Basiri Moghadam
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
basiri1344@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for reserarch of Gonabad university of medical sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of EMLA cream with rattles on reducing immunization pain in infants of four months
Public title
Comparison of EMLA cream with rattles on reducing immunization pain in infants of four months
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being awake and calm before vaccination; not suffering from diarrhea and colds during the vaccination; term infants; analgesic drug for 48 hours before vaccination is not received by the mother and infant. Exclusion criteria: mother refusing to continue after applying EMLA cream.
Age
From 4 years old to 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Gonabad univercity of medical sciences
Street address
Vice chancellor for research, Gonabad university of medical sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90/7
Health conditions studied
1
Description of health condition studied
The pain of vaccine
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
pain
Timepoint
Before, during and after injection
Method of measurement
modified behavioral pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: routine procedures
Category
N/A
2
Description
EMLA group: In addition to routine procedures, applying 2 g of EMLA cream in place of vaccine
Category
Prevention
3
Description
Rattles group: In addition to routine procedures, Shaking rattles from 30 seconds before until 15 seconds after injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of Gonabad city
Full name of responsible person
Street address
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Ali Ekrami
Street address
Gonabad University of Medical Sciences and Health Services, Next to the Asian Road
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Basiri Moqadam
Position
Master of Science in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences and Health Services, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3733 2629
Fax
+98 53 3722 3814
Email
Basiri1344@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical sciences
Full name of responsible person
Mahdi Basiri Moghadam
Position
Master of Science in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Vice chancellor for research, Gonabad University of Medical Sciences and Health Services, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3733 2629
Fax
+98 53 3722 3814
Email
basiri1344@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of medical sciences
Full name of responsible person
Mahdi Basiri Moghadam
Position
Master of Science in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Vice chancellor for research, Gonabad University of Medical Sciences and Health Services , Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3733 2629
Fax
+98 53 3722 3814
Email
basiri1344@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)