The effect of shot blocker on vaccine pain in infants
Design
In this study, 80 cases of 6-month-old infants referred to Birjand Mehrshahr Comprehensive Health Services Center were selected by convenience sampling method and randomly assigned into two groups of block shot and control group.
Settings and conduct
In this single-blind study, the research setting will be Mehrshahr Integrated Health Services Research Center in Birjand. There is a test group and a 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: six-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
The test group will use a blocker shot 20 seconds before injection until the end of the vaccine injection And in the control group there will be no intervention and they will be vaccinated according to the routine of the center.The modified behavioral pain scale (flacc) and cry time will use to assess pain scores 15 second after immunization.
Main outcome variables
Pain severity; crying duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191128045534N1
Registration date:2020-04-22, 1399/02/03
Registration timing:retrospective
Last update:2020-04-22, 1399/02/03
Update count:0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
ghazal afshari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
ghazalafshari505@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-04, 1398/09/13
Expected recruitment end date
2020-03-03, 1398/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of shotblocker on vaccination pain among infants
Public title
The Effect of Blocker on Infant Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Qualify for a fivefold vaccine
birth is term (37-42)
Child's growth curve is normal
the child is quiet and without crying
Infant diaper is dry
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
history of surgery and hospitalization
Cerebral palsy
Mental retardation
Acute or chronic illness
Age
From 6 months old to 6 months old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
he allocation is via random blocks such that in each block, there will be two individuals. The first person will choose one of the two envelopes and will be placed in one of the two groups, and the other one will then be drawn into the other one groups by the same token
Blinding (investigator's opinion)
Single blinded
Blinding description
What is meant to be omitted from a single blind is that the researcher's assistant, the person reviewing the film to assess pain scores, is unaware of the aims and assumptions of the research, but that complete blinding is not possible, and that the aim was even with these measures. Reduce bias whenever possible
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ghazalafshari
Street address
Central Organization of Birjand University of Medical Sciences, Khorasan, Birjand, Ghafari Street
City
birjand
Province
South Khorasan
Postal code
۳۲۳۹۵۰۰۰
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.BUMS.REC.1398.238
Health conditions studied
1
Description of health condition studied
Vaccine pain in infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
20seconds befor vaccination Until the end of the injection
Method of measurement
flacc scale
2
Description
cry time
Timepoint
injection until the end of time crying
Method of measurement
cronometr
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The test group will use a shotblocker 20 seconds before the end of the vaccine injection.
Category
Other
2
Description
Control group: Control group will receive standard care in health centers.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehrshahr Health Center
Full name of responsible person
ghazalafshari
Street address
Birjand - Mehrshahr - Imam Ali Street - Corner of Imam Ali 4
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3230 8315
Email
Ghazalafshari505@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari Street
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
ghazalafshari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
ghazalafshari505@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
ghazalafshari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences, school in Nursing and Midwifery, Ghaffari Street
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 1444 0550
Email
ghazalafshari505@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
ghazqalafshari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 1444 0550
Email
ghazalafshari505@yahoo.com
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