Protocol summary

Summary
The aim of current study was to examine the effect of distraction technique and oral sucrose in reducing pain due to vaccination. inclusion criteria was awake and silent of infant with score pain maximum ,pad infand dried , absence of confiend to bed hospital casuse medical or surgical , absence of cold or diearrhea time of vaccination , term baby , abcence of recive analgesic before 48 hours vaccination and exclusion criteria was mother not permitted is continous intervention , mother interrest to embrance baby before of finishing intervention and evaluation . this controlled trial study was performed on 152 healthy infants that were randomly assigned to distraction technique (n=38), oral sucrose(n=38) and application of oral sucrose and distraction together(n=38) and routine care(n=38).For Infants in distraction group, investigator provided distraction(Rattle), 30 second before, during, and 15 second after the injection, infant in sucrose group received 2 ml oral sucrose 2 minute before injection, and together group received 2 ml oral sucrose 2 minute before injection and after 90 second investigator provided distraction(Rattle) to 15 second after injection , and control group according to routine clinic lied on the examining table. The results showed that the MBPS scores were significantly lower in distraction group and sucrose groupand both groups compared with the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809012751N1
Registration date: 2012-11-26, 1391/09/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-26, 1391/09/06
Registrant information
Name
Masoomeh Kheirkhah
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8247 1000
Email address
kheirkhah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Oral sucrose, Distraction and application of oral sucrose and distraction together on pain infants immunization injection
Public title
Comparison of the effect of oral sucrose, distraction and application of oral sucrose and distraction together on pain infants immunization injection, health centers of West Tehran 2009 ”
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria : 1- awake and silent of infant with score pain maximum 3 2- pad infand dried 3- absence of confiend to bed hospital casuse medical or surgical 4- absence of cold or diearrhea time of vaccination 5- term baby 6- abcence of recive analgesic before 48 hours vaccination exclusion criteria : mother not permitted is continous intervention 2- mother interrest to embrance baby before of finishing intervention and evaluation .
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
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
Iran Univercity of Medical Science and Health Services
Street address
Shahid Easami St, Vanak avenue, Faculty Nursing and Midwifery
City
Tehran
Postal code
Approval date
2009-06-16, 1388/03/26
Ethics committee reference number
1289503

Health conditions studied

1

Description of health condition studied
Persons encountering health services for examination and investigation
ICD-10 code
Z00.6
ICD-10 code description
Examination for normal comparison and control in clinical research programme

Primary outcomes

1

Description
The Effect of Distraction Technique and Oral Sucrose in Reducing pain due to Vaccination.
Timepoint
During 5 second before immunization to 15 second after
Method of measurement
Modified Behavioral Pain Scale (MBPS)

Secondary outcomes

1

Description
Reduce of on pain due to vaccination injection
Timepoint
Reduce of on pain due to vaccination injection
Method of measurement
Reduce of on pain due to vaccination injection

Intervention groups

1

Description
Effect of oral sucrose, distraction and application of oral sucrose and distraction together on pain due to vaccination injection,
Category
Prevention

2

Description
2 ml oral sucrose25% among 30 second with niddle and 2fter 2 min vaccination injection doing in intervention isucrose group received
Category
Prevention

3

Description
30 second before, during, and 15 second after the injection Rattle in used.
Category
Prevention

4

Description
Both groups received 2 ml oral sucrose 2 minute before injection and after 90 second investigator provided distraction(Rattle) to 15 second after injection
Category
Prevention

5

Description
Control group according to routine clinic lied on the examining table
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of West Tehran
Full name of responsible person
Honarvari
Street address
Ostad moin st, Dastgib st, Health Centers of West Tehran, Tehran . Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran university of Medical Science and Health Services
Full name of responsible person
Mazear Moradi Laleh
Street address
Hemmat great way , Iran University Medical Science
City
Tehran
Grant name
Grant code / Reference number
پ/777
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran university of Medical Science and Health Services
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science and Health Services
Full name of responsible person
Masoomeh Kheirkhah
Position
Master Science
Other areas of specialty/work
Street address
Easami st , Vanak ave, Faculty Nursing and Midwifery
City
Tehran
Postal code
1438783941
Phone
+98 21 8801 3887
Fax
Email
m-kheirkhah@tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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