Objective: study of comparative effect of balloon inflation and distraction techniques on intravenous catheter pain among 4-7 years old children. Methods: 90 child [balloon group (30), distraction group (30) and control group (30)] were selected by using available random sampling from 4-7 years old children community admitted in Ghods hospital of Qazvin, Iran in 1387. Questionnaire of this study included three sections: demographic, Wong-Baker (FACES) Pain Rating Scale and scale of reactions and behaviors caused by pain FLACC (Face Legs Arms Cry Consolability Scale). In Balloon and distraction group, before injection we talked with child and trained them how to inflate balloon and press a rubber ball. During intravenous catheter using tools, the level of pain was determined, but in the control group without any intervention intravenous catheter was injected and then the level of pain for this group was determined; and ultimately the rate of pain in the three groups were compared together using inferential statistics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808182688N1
Registration date:2008-06-26, 1387/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-06-26, 1387/04/06
Registrant information
Name
Tahereh Sadeghi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0990
Email address
tsadeghi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin university of madical sciences
Expected recruitment start date
2008-06-26, 1387/04/06
Expected recruitment end date
2008-09-29, 1387/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Evaluation of effect of Balloon Inflation and distractions on self report pain and behavior reactions of venipuncture in 4-7 year children
Public title
Effect of balloon inflation and distraction techniques on intravenous catheter pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1-Age of 4-7 years and need to intravenous catheter, 2-Before injecting intravenous catheter, Wong-Baker FACES Pain Rating Scale should be zero. Exclusion criteria: 1-no history of hospitalization, 2-no history of injection of intravenous catheter, 3- not to use any particular drug, (drugs that affect on child's consciousness), 3-no Specific diseases (such as hypothyroidism, epilepsy and cardiovascular disease...), 4- acute disease that decreases child consciousness.
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Qazvin university of medical sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qzvin
Postal code
Approval date
empty
Ethics committee reference number
1429
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
before and after the venipuncture
Method of measurement
Pain Assessment Scale
Secondary outcomes
1
Description
Complication of pain control
Timepoint
during Venipuncture
Method of measurement
Pain Assessment Scale
Intervention groups
1
Description
distraction during injection
Category
Treatment - Other
2
Description
balloon inflation during injection
Category
Treatment - Other
3
Description
no intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Tahereh Sadeghi
Street address
Qods Square
City
Qzvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Akram Shahrokhi
Street address
Shahid Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Faculty Member, School of Nursing Midwifery
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 912 614 7746
Fax
Email
tsadeghi@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin university of medical sciences
Full name of responsible person
Tahereh Sadeghi
Position
BSc / Faculty Member, School of Nursing Midwifery
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qzvin
Postal code
Phone
+98 28 1336 0990
Fax
Email
tsadeghi@Qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Tahereh Sadeghi
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)