Comparing the effect of music and oral sucrose on vaccination's pain in infants.
Design
The clinical trial consisted of two intervention groups, one control group, single -blind and randomized on 135 infants. Children are assigned to groups based on a randomization sequence and first in first out that will be generated in advance, which is unpredictable and has no certain pattern. To assign samples to 3 groups, the block randomization method with the size of 3 and 6 blocks using block random number generator software will be used.
Settings and conduct
This study will be performed in health centers of Khomein city and in infants referred for injection of the Pentavalent vaccine.
Participants/Inclusion and exclusion criteria
Inclusion criteria: awakening of the infant; healthy hearing and eligibility for taking Pentavalent vaccine.
exclusion criteria: no history of hospitalization due to illness or surgery; no cold or diarrhea during vaccination; no taking of analgesic for 48 hours before vaccination.
Intervention groups
In the first intervention group (music), the melody of golden dreams by Javad Maroufi will be played from a distance of one meter from three minutes before to three minutes after the injection of the vaccine. The volume will be adjusted by Pazhand Teb Company using the mod-Tes 1354 sound meter made by Tes Taiwan Company at 65 decibels.
In the second intervention group (sucrose), one ml of 24% sucrose solution will be given to the infant, after ten seconds, vaccination will be performed. The sucrose powder used in this study is a product of Merck Company.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N12
Registration date:2021-02-23, 1399/12/05
Registration timing:registered_while_recruiting
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of music and oral sucrose on vaccination's pain in infants.
Public title
The effect of music and oral sucrose on vaccination's pain.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Awakening of the infant
Healthy hearing of the child
Having the conditions to receive Pentavalent vaccine
Exclusion criteria:
No history of hospitalization due to illness or surgery
No colds or diarrhea during vaccination
No taking of Analgesic (painkiller) for 48 hours before vaccination
Age
From 6 months old to 6 months old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Children are assigned to two intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 and 6 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the three groups. First, all the modes in which the 3 letters A, B and C can be put together in blocks of 3 and 6 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate children. Finally this block will be placed in the main container and another block will be selected again. Blocks of 3 and 6 will all be in the same container. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know how the samples are placed in the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam al-Huda St., Railway Square
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-11-02, 1399/08/12
Ethics committee reference number
IR.ARAKMU.REC.1399.223
Health conditions studied
1
Description of health condition studied
Vaccination's pain in infants.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
After intervention
Method of measurement
The pain scale used in this study is MBPS (Modified Behavioral Pain Scale).
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: music The melody of golden dreams by Javad Maroufi will be played from a distance of one meter from three minutes before to three minutes after the injection of the vaccine. The volume will be adjusted by Pazhand Teb Company using the mod-Tes 1354 sound meter made by Tes Taiwan Company at 65 decibels.
Category
Other
2
Description
The second Intervention group: sucrose One ml of sucrose solution 24% will be given to the infant, after ten seconds, vaccination will be performed. The sucrose powder used in this study is a product of Merck Company.
Category
Other
3
Description
Control group: In this group there is no intervention, only vaccination will be performed then the infant's pain intensity will be measured in a appropriate way by modified behavioral pain scale(MBPD).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Khomein city
Full name of responsible person
Mahbobeh Sajadi
Street address
Basij Sq., Sardasht Region, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 4634 3493
Email
zeynabbeheshti7941@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
دکتر علیرضا کمالی
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 4634 3493
Email
sajadimahbobeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
80
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
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098 863 41735057
Email
sajadimahbobeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098 863 41735057
Email
sajadimahbobeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098 863 41735057
Email
sajadimahbobeh@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
since the summer of 2021
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
In order to control pain in infants
From where data/document is obtainable
Vice Chancellor for Education and Research, Arak University of Medical Sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak University of Medical Sciences