This study will be carried out in 2016 with the aim to determine the effect of inflating the balloon on the amount of pain during intravenous blood sampling for children 4-7 years old hospitalized in pediatric ward of Imam Khomeini Hospital Jiroft. A study (single-blind for both intervention and control groups due to lack of awareness of any group from the existence of the other group) on 80 children admitted to the pediatric ward who have the inclusion conditions will be done after obtaining personal consent from parents. Children will be placed randomly in one of the intervention group (n = 40) and control group (n = 40) that in the intervention group, pediatric pain during intravenous blood sampling will be measured at the same time with inflating balloon and in the control group, only pediatric pain during blood collection will be measured without any intervention. For pain assessment, Wong-Baker FACES Pain Rating Scale (WBS) will be used.
General information
Acronym
NOT
IRCT registration information
IRCT registration number:IRCT2016111329817N2
Registration date:2017-02-11, 1395/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
NOT
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Reviews the impact of the wind down the balloon on the amount of pain when venous blood ¬ dial in children admitted to the children's section
Public title
The impact of the wind down the balloon on the amount of pain when venous blood ¬ dial
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion criteria: children 4-7 years; written informed consent to participate in the study by parents, lack of known hypersensitivity to plastic materials in children, the lack of a specific disease in children (thyroid disorders, epilepsy and cardiovascular diseases and children hyperactivity), lack of disease or specific medication use that may result in lowering of consciousness. Exclusion criteria: children who visit more than once for blood sampling; children who do not clear vessel; children who have a history of hospitalization).
Age
From 3 years old 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
NOT
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman, the beginning of tCampus University of Medical Sciences, beginning around seven gardens Alavi, Kermanhe boulevard Haft Bagh Alavi, Medical Sciences Campus
City
Kerman
Postal code
--
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.Kmu.REC.1395.260
Health conditions studied
1
Description of health condition studied
pain in childraen
ICD-10 code
--
ICD-10 code description
--
Primary outcomes
1
Description
pain
Timepoint
Before and after intervention
Method of measurement
The questionnaire Wong-Bakker
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, a balloon is given to children and asked them to inflate it all the time of blood sampling (up to 10 seconds).
Category
Other
2
Description
In the control group, just blood sampling is done with no intervention.