Immunization is a common painful event during childhood, which is typically performed without pain control. Regarding Importance of pain control in children, the purpose of this study was to investigate the effectiveness of the two methods of distraction (inflating a balloon and watch cartoons) on pain of Diphtheria –Tetanus- Pertussis (DTP) vaccine in school age children.
In a clinical trial,120 healthy at school age children who received DTP vaccine at Seyedoshohada health care center of Zahedan were randomly divided into three groups: In group1 one minute before and during the vaccination a distraction technique (blowing up balloons by children) was used. In group2 five minutes Cartoon Film was displayed on Lap tops (two minutes before and three minutes during and after vaccination) and in group 3 (control group), children were vaccinated according to routine instruction health centers. In all of groups, vaccine was injected in similar conditions and by a trained person. Primary outcomes included pain scores of children immediately after the DTP vaccine injection. The Pain score was assessed by the Behavioral Pain Scale (FLACC Scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080313889N2
Registration date:2016-01-02, 1394/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-02, 1394/10/12
Registrant information
Name
Hasan Robabi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1243 6643
Email address
robabi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of distraction through inflating balloon and watching cartoons on DTP pain vaccine in school age children
Public title
Comparison of the effect of inflating balloon and watching cartoons on the pain of DTP vaccine in school age children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. having DPT vaccine qualification.
2. No history of surgery or hospitalization.
3. Not having serious illness.
4. Eating breakfast before the injected vaccine.
Exclusion criteria: Consuming sedative or hypnotic in last 24 hours.
Age
From 6 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a clinical trial study. Randomized selecting sampling was performed through placing letters A, B and C in envelope which for each participant as follows: ask children select one of these letters, letters A ,B and C indicated of group injection1, 2, 3 respectively.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Vice Chancellor for research, Zahedan University of Medical Sciences -Dr Hesabi Square- Zahedan
City
Zahedan
Postal code
98167-43463
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.ZAUMS.REC.1394.62
Health conditions studied
1
Description of health condition studied
Pain of injection vaccine
ICD-10 code
Z27.1
ICD-10 code description
Need for immunization against diphtheria-tetanus-pertussis, combined [DTP]
Primary outcomes
1
Description
pain score of DTPvaccine injection
Timepoint
Immediately after DTPvaccine injection
Method of measurement
children Pain Scale(FLACC Scale)
Secondary outcomes
empty
Intervention groups
1
Description
blowing up balloons by children one minute and during the vaccination
Category
Prevention
2
Description
Five minutes Cartoon Film displaying(two minutes before and three minutes during and after DTP vaccination)
Category
Prevention
3
Description
children were vaccinated according to routine health centers
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada Health Care Center
Full name of responsible person
Hasan Robabi
Street address
Seyedoshohada Health Care Center - Shahid Rajaie str. Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Zahedan University of Medical Sciences
Full name of responsible person
Dr M.Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences -Dr Hesabi Square- Zahedan
City
Zahedan
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,Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe Kerman Saravi
Position
MSc/ Instructor of Nursing, Zahedan Nursing and Midwifery School
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery - Mashahir Square - Zahedan
City
Zahedan
Postal code
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
Fatihe @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Robabi
Position
MSc/ Instructor of Nursing, Zahedan Nursing and Midwifery School
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery - Mashahir Square - Zahedan
City
Zahedan
Postal code
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
harobabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Robabi
Position
MSc/ Instructor of Nursing, Zahedan Nursing and Midwifery School
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery - Mashahir Square - Zahedan
City
Zahedan
Postal code
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
harobabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)