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IRCT20180114038361N1 IRCT 2018-06-18 Mashhad University of Medical Sciences The effect NIDCAP on pain caused by eye examination of screening for ROP Study of the effect of Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on pain caused by eye examination of screening for retinopathy of prematurity. 2018-08-23 anticipated 60 Complete https://irct.ir/trial/29013 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: َA blinded person (supervisor) will watch the videos and will set score of the PIPP tool. N/A Retinopathy of Permaturity. Intervention 1: Intervention group: Newborn Individualized Developmental Care and Assessment Program (NIDCAP). Intervention 2: Control group: Infants of the control group are under common actions which are pouring anesthetic drops into their eyes and then eye examination by RetCam digital imaging system to determine their pain score based on PIPP tool. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no need to add this types of data to published information
public Monir Ramezani
School of Nursing and Midwifery, Doctora Junction, Eibn-sina st.
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3841 3007 ramezanim@mums.ac.ir Mashhad University of Medical Sciences scientific Monir Ramezani
School of Nursing and Midwifery, Doctora Junction, Eibn-sina st.
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3859 1511 ramezanim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Newborn infant with gestational age less that 34 weeks or birth weight less than 2000 g which four weeks have passed since their birth. Infant's mothers are present Their parents are satisfied to participate in this research At least one hour has passed from infant's feeding Infants must be calm and alert Infants must have no surgical history Infants must have no major congenital disorders like congenital heart or central nervous system disorders Infants take no sedatives in past 24 hours no limit 1 month Both Infants which need ventilator during examination Infants which had asphyxia during examination H35.1 Retinopathy of prematurity Behavior Behavior Intervention group: Newborn Individualized Developmental Care and Assessment Program (NIDCAP) Control group: Infants of the control group are under common actions which are pouring anesthetic drops into their eyes and then eye examination by RetCam digital imaging system to determine their pain score based on PIPP tool. Pain caused by eye exam of retinopathy of prematurity. Timepoint: Before, during and after eye exam. Method of measurement: using premature infant pain profile tool. Mashhad University of Medical Sciences Approved 2017-11-12 Ethics committee of Mashhad University of Medical Sciences Fakouri Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)