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IRCT20141004019399N2 IRCT 2018-09-02 Mashhad University of Medical Sciences Comparison of topical cryotherapy and Non-Nutritive Sucking on the pain caused by vaccine injection Comparison of the effect Cooling Gel Pad Versus Non-Nutritive Sucking on the pain caused by the injection of hepatitis vaccine in newborns 2014-06-20 anticipated 90 Complete https://irct.ir/trial/17346 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization. N/A pain. Intervention 1: Intervention group1:The first group we laid 90 second Cooling Gel Pad on selected tissue region then injection performed in same cooled region. Intervention 2: Intervention group2: The second group, sucking was done for 2 minutes before and during the injection of the vaccine. Intervention 3: Control group : The control group did not receive any intervention during vaccine injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is Babies are admitted to the mother's case and there is no comprehensive information.
public Hadi Najafi
School of Nursing and Midwifery, Doctora Crossroadsوءشساء
Mashhad Iran (Islamic Republic of) 91775-1365 +98 51 3859 1511 najafih901@mums.ac.ir Mashhad University of Medical Sciences scientific soheila karbandi
School of Nursing and Midwifery, Doctora Crossroads
Mashhad Iran (Islamic Republic of) 91775-1365 +98 51 3859 1511 karbandis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Parent's informed consent and cooperation fetal gestational age 42-37 weeks 4000-2500 gm birth weight At least the last two hours of birth Within 24 hours of birth is past Body temperature is between 37.2 to 36 At least 30 minutes have passed since the last feeding a baby Babies do not have addicted mothers 1 day 1 day Both No desire to cooperate and participate parents Mothers who are taking anti-epileptic drugs and anti convulsants The baby cried, severe restlessness Poor sucking and non- effective infant M79.60 Pain in limb, unspecified Rehabilitation Rehabilitation Rehabilitation Intervention group1:The first group we laid 90 second Cooling Gel Pad on selected tissue region then injection performed in same cooled region. Intervention group2: The second group, sucking was done for 2 minutes before and during the injection of the vaccine. Control group : The control group did not receive any intervention during vaccine injection. Intensity of pain. Timepoint: Every 30 seconds to 2 minutes after the needle is inserted. Method of measurement: neonatal infant pain scale(NIPS). Duration of crying. Timepoint: Cry time was recorded during 2 minutes after needle penetration by stopwatch. Method of measurement: by Stopwatch. Mashhad University of Medical Sciences Approved 2014-03-15 Ethics Committee of Mashhad University of Medical Sciences Deputy of Research and Technology University, Building Qureshi, Daneshgah ُSt, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)