Comparison of the effect of vibration bee with heat or cold on the pain of Intravenous catheter insertion in 3-6 years old children
Design
A randomized controlled clinical trial (3 groups) with parallel group, double-blind ( evaluator and statistical).
Settings and conduct
location: Emergency Department and Clinic of Mashhad Pediatric Hospital.
Patients will be included in the study with inclusion criteria and will be excluded if excluded. First, the purpose of the study is explained to children (who are eligible for inclusion) and their parents. After obtaining verbal consent from the child and written consent from the parents, the children will be included in the study. The intervention will be performed by the nurse injecting the intravenous catheter and the assessor will be blind. Questionnaires will be written in group code and the assessor will be blinded.
Participants/Inclusion and exclusion criteria
Child 3 to 6 years old with elective problem
The first experience of injection for child in this admission.
The child has no sensory-neurological, vascular, hematologic, verbal and cognitive impairment and chronic illness
Before intervention, the child is alert and has not received sleepy, sedative and narcotic drugs.
Intervention groups
First Intervention group : Heat vibrating bee group: The vibrate bee puppet, which is attached to a warm bag with a local heat of 39-40 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply.
Second Intervention group : At the same condition; But the cold bag is used at zero degrees instead of the local heat.
Control group ; Group of vibrating bees at room temperature
Main outcome variables
Reduce the pain of intravenous catheter insertion for children
General information
Reason for update
Acronym
زنبوک ویبره
IRCT registration information
IRCT registration number:IRCT20181104041553N1
Registration date:2019-09-13, 1398/06/22
Registration timing:registered_while_recruiting
Last update:2019-09-13, 1398/06/22
Update count:0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Maryam Sahebkar Moeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 7980
Email address
sahebkarmm961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-31, 1398/06/09
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vibration bee with heat and cold on the pain caused by intravenous cannula insertion in children 3 to 6 years
Public title
Comparison of the effect of vibration bee with heat and cold and room temperature on the pain caused by intravenous cannula insertion in children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Child 3 to 6 years old with elective surgery
Before entering the section or operating room, child need to Intravenous Catheter insertion
At least one of the parents is present during Intravenous Catheter insertion
The first experience of injection for child in this admission.
The injection site is internal flexure of elbow or forearm and should not have a scar or skin problem
The child has no sensory-neurological, vascular, hematologic, verbal and cognitive impairment and chronic illness
Before intervention, the child is alert and has not received sleepy, sedative and narcotic drugs
Before the intervention, the child's pain level is below three with the Wong-Baker FACES tool
The child and parents have informed consent to participate in the intervention
Exclusion criteria:
Dissatisfaction of parents and the child from the research
Not successful first injection
If the catheter insertion to the vein after it enter into the hand of child, it will take more than 20 seconds.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The method used to generate a random allocation sequence is blocked.
Block randomization ensures that there are no groups between the groups at any time interval during the randomization of a significant imbalance, and at each point the number of participants in each group is equal. Sampling in this research will be that sampling initially will be conducted in a "non-random" way for the purpose of children entering the research and assigning them to 3 groups (groups: vibration bee with heat/ vibration bee with cold/ vibration bee with room temperature) will be random; In this way, the assignment of samples to intervention groups (vibration bee with heat and vibration bee with cold) or control group(vibration bee with room temperature) will be done by random assignment (lottery by blocking). In this intervention, we have three groups; first by assigning the code to the groups, the groups will be determined(Group A: vibration bee with heat and Group B: vibration bee with cold and Group C: vibration bee with room temperature). 6 blocks with 3 pieces Characterized [(ABC(1)- ACB (2)-CAB (3)-BCA (4)- CBA (5)- BAC(6)]. Then, random numbers are selected between one to six (eg, 1, 4, 5, ...), and finally the list of treatment allocations based on random numbers will be determined. By drawing a lot, it will be clear what the sequence of doing the job is.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurse who do this procedure(Intravenous Catheter Insertion) draws and either cools or warms the pack itself (in the intervention group) or at room temperature (in the control group):Therefore, the researcher will be blind when scoring on the relevant tool (for evaluation of the outcome) .
Only the code for each child's tool will be written: so the statistical evaluator will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad School of Nursing and Midwifery, Ibn Sina Street, Doctoral intersection, University Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-06-13, 1398/03/23
Ethics committee reference number
شماره IR.MUMS.NURSE.REC.1398.019
Health conditions studied
1
Description of health condition studied
the pain induced with Peripheral venous catheter
ICD-10 code
ICD-10 code description
R52.0
Primary outcomes
1
Description
Pain caused by Peripheral Vein Catheter Insertion
Timepoint
Before and Immediately after Peripheral Vein Catheter Insertion
Method of measurement
Wong-Baker FACES
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group : Heat vibrating bee group: The vibrate bee puppet, which is attached to a warm bag with a local heat of 39-40 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply.
Category
Treatment - Devices
2
Description
Second Intervention group : Cool vibrating bee group: The vibrate bee puppet, which is attached to a cool bag with a local cold of 0 ° C below, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply.
Category
Treatment - Devices
3
Description
Control group: vibrating bee group with room temperature : The vibrate bee puppet, will be closed for 5 minutes at the location mentioned and in the last minute the vibration will apply.