Infants routinely undergo painful procedures, such as immunization injection and heel lancing. Therefore, recognition and application of pain control strategies by health care worker is necessary. The objective of this study is to assess the effect of distraction on immunization injection pain in infants. This study is a randomized controlled trial that will be performed on healthy infants, who will be brought to Sajadshahr health center of birjand University of Medical Sciences by their mother and have DPT immunization. 80 healthy infants were randomly will assigne to experimental and control groups.During immunization, experimental group will receive a rattle as a distraction technique by the researcher 45seconds before vaccination until 15 seconds after, while the control group will receive standard care in health centers. The modified behavioral pain scale (MBPS) and cry time will use to assess pain scores 15 second after immunization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107277130N1
Registration date:2012-03-21, 1391/01/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-21, 1391/01/02
Registrant information
Name
Zahra Younesi
Name of organization / entity
Birjand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 0550
Email address
z-unesi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2012-01-10, 1390/10/20
Expected recruitment end date
2012-06-09, 1391/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Distraction Technique on Reducing the Infant's
Pain due to Immunization
Public title
The Impact of Distraction Technique on Reducing the Infant's
Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Breast feeding is the dominant; birth is term (37-42); Child's growth curve is normal; the child is quiet and without crying; child and mother have not received analgesia or sedative medications during 48h prior to the study; Infant diaper is dry; infant is eligible for DPT vaccination. Exclusion criteria: Child has history of surgery, hospitalization; Child with cerebral palsy and is mentally retarded; Child has acute or chronic illness.
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
Approval date
2011-10-04, 1390/07/12
Ethics committee reference number
58415/125
Health conditions studied
1
Description of health condition studied
immunization injection pain in infants
ICD-10 code
Z27.1
ICD-10 code description
Need for immunization against diphtheria-tetanus-pertussis, combined [DTP]
Primary outcomes
1
Description
pain
Timepoint
15 seconds after vaccination
Method of measurement
modified behavioral pain scale (MBPS)
2
Description
cry time
Timepoint
Injection until the end of time crying
Method of measurement
seconds
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group will receive a rattle as a distraction technique by the researcher, 45 seconds before vaccination until 15 seconds after that.
Category
Other
2
Description
Control group will receive standard care in health centers.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sajadshahr Health Center
Full name of responsible person
Zahra Younesi
Street address
Sajadshahr Health Center, Sajadshahr
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohamad Darmiani
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Grant name
Grant code / Reference number
496
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zahra Younesi
Position
MS in Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, school in Nursing and Midwifery, Ghaffari Street
City
Birjand
Postal code
Phone
+98 56 1444 0550
Fax
Email
z-unesi@bums.ac.ir , unesi500@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Younesi
Position
MS in Nursing
Other areas of specialty/work
Street address
Birjand University Of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
Phone
+98 56 1444 0550
Fax
+98 56 1444 0550
Email
z-unesi@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)