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IRCT20161210031328N12 IRCT 2021-02-23 Arak University of Medical Sciences The effect of music and oral sucrose on vaccination's pain. Comparing the effect of music and oral sucrose on vaccination's pain in infants. 2020-12-20 anticipated 135 Complete https://irct.ir/trial/52736 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 description: The data analyzer will not know how the samples are placed in the intervention and control groups. N/A Vaccination's pain in infants.. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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). Yes - There is a plan to make this available What will be shared: Only part of the data related to the original outcome will be able to be shared. When: since the summer of 2021 To whom: Researchers and students in this field Conditions: In order to control pain in infants Where to obtain: Vice Chancellor for Education and Research, Arak University of Medical Sciences How to obtain: These documents will be available on the website of Arak University of Medical Sciences Comments:
public Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 0098 863 41735057 sajadimahbobeh@yahoo.com Arak University of Medical Sciences scientific Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 0098 863 41735057 sajadimahbobeh@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Awakening of the infant Healthy hearing of the child Having the conditions to receive Pentavalent vaccine 6 months 6 months Both 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 Other Other Other 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. 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. 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). Intensity of pain. Timepoint: After intervention. Method of measurement: The pain scale used in this study is MBPS (Modified Behavioral Pain Scale). Arak University of Medical Sciences Approved 2020-11-02 Ethics Committee of Arak University of Medical Sciences Arak University of Medical Sciences, Alam al-Huda St., Railway Square Arak Markazi Iran (Islamic Republic of)