Comparing the effects of hand-pressure, combination of vibration and cold, and routine infusion on pain induced by vaccine injection in 4-month-old children
Comparing the effects of hand-pressure, combination of vibration and cold, and routine infusion on pain induced by vaccine injection in 4-month-old children
Design
Ninety 4-month-old infants referring to Tohid Comprehensive Health Services Center in Birjand and eligible for inclusion in the study will be selected via convenience sampling method and randomly assigned into three groups of hand pressure, vibration and cold, and control.
Settings and conduct
In this double-blind study, the research setting will be Tohid Center of Comprehensive Health Services in Birjand. There are two intervention groups and one control group. In addition to the participants who are unaware of their allocations, two individuals who are not aware of the objectives of the project will check the videos and review the variables of the study after the sampling is completed.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Four-month-old children; guardian consent for participation in the study; referral to receive the pentavalent vaccine; and term baby at birth (37-42 weeks). Main exclusion criteria: Consumption of analgesics by the child and mother during 48 hours before intervention; history of injections other than post-birth vaccine and screening tests.
Intervention groups
Intervention group 1 (hand pressure): After placing the child on the vaccination bed, hand pressure is applied to the injection site with the thumb, such that the thumb will be posited 0.5 centimeters above the injection site, and the pressure is applied until tissue resistance is observed and the thumb whitening is occured. The pressure is applied from 10 seconds before until the end of the injection. Intervention group 2 (cold vibration): A device inducing vibration and cold called Buzzy is placed 0.5 centimeters above the injection site and after 10 seconds, the injection is performed. Control group: The children will be vaccinated according to the routine procedure.
Main outcome variables
Pain severity; crying duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N46
Registration date:2018-08-30, 1397/06/08
Registration timing:registered_while_recruiting
Last update:2018-08-30, 1397/06/08
Update count:0
Registration date
2018-08-30, 1397/06/08
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of hand-pressure, combination of vibration and cold, and routine infusion on pain induced by vaccine injection in 4-month-old children
Public title
Impact of hand-pressure and combination of vibration and cold on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Four-month-old children
guardian consent for participation in the study
term baby at birth (37-42 weeks)
referral to receive the pentavalent vaccine
normal growth curve between the 5th and 95th percentiles
children who are calm, awake, and without crying
The baby's diaper should be dry
Exclusion criteria:
Consumption of analgesics by the child and mother from 48 hours before intervention
history of injections other than post-birth vaccine and screening tests
history of surgery and hospitalization
Cerebral palsy or mental retardation
Acute or chronic illness
Age
From 4 months old to 4 months old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation is via random blocks such that in each block, there will be three individuals. The first person will choose one of the three envelopes and will be placed in one of the three groups, and the other two will then be drawn into the other two groups by the same token.
Blinding (investigator's opinion)
Double blinded
Blinding description
In addition to the participants who are unaware of their allocations, two individuals who are not aware of the objectives of the project will check the videos and review the variables of the study after the sampling is completed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.BUMS.REC.1397.50
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
pain severity
Timepoint
15 seconds after injection for 1 minute
Method of measurement
FLACC Behavioral Pain Assessment Scale
2
Description
Crying duration
Timepoint
From the injection moment to the end of crying
Method of measurement
stopwatch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (hand pressure): After placing the child on the vaccination bed, hand pressure is applied to the injection site with the thumb, such that the thumb will be posited 0.5 centimeters above the injection site, and the pressure is applied until tissue resistance is observed and the thumb whitening is occurred. The pressure is applied from 10 seconds before until the end of the injection.
Category
Prevention
2
Description
Intervention group 2 (cold vibration): A device inducing vibration and cold called Buzzy is placed 0.5 centimeters above the injection site and after 10 seconds, the injection is performed.
Category
Prevention
3
Description
Control group: The children will be vaccinated according to the routines of the center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Comprehensive Health Services Center
Full name of responsible person
Azar Sajed
Street address
Valiasr St., Mehrshahr
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3230 8315
Email
sajed@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Azar Sajed
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1361
Email
sajed@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Yunesi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 32381425
Email
z-unesi@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3244 0447
Email
mbroozgar@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
When the extracted paper is published and for 6 months
To whom data/document is available
for researchers
Under which criteria data/document could be used
research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document