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IRCT20140519017756N46 IRCT 2018-08-30 Birjand University of Medical Sciences Impact of hand-pressure and combination of vibration and cold on pain 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 2018-06-22 anticipated 90 Complete https://irct.ir/trial/33203 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. 1-2 Pain. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: The children will be vaccinated according to the routines of the center. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set When: When the extracted paper is published and for 6 months To whom: for researchers Conditions: research purposes Where to obtain: personal correspondence with the corresponding author How to obtain: email Comments:
public Azar Sajed
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3238 1361 sajed@bums.ac.ir Birjand University of Medical Sciences scientific Zahra Yunesi
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 32381425 z-unesi@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) 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 4 months 4 months Both 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 G89.18 Other acute postprocedural pain Prevention Prevention N/A 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. 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 routines of the center. Pain severity. Timepoint: 15 seconds after injection for 1 minute. Method of measurement: FLACC Behavioral Pain Assessment Scale. Crying duration. Timepoint: From the injection moment to the end of crying. Method of measurement: stopwatch. Birjand University of Medical Sciences Approved 2018-05-28 Ethics Committee of Birjand University of Medical Sciences Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)