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IRCT20190105042245N1 IRCT 2019-02-24 Kerman University of Medical Sciences Comparison the effect of breastfeeding and oral glucose (10%) on the severity of pain and physiologic characteristics due to venous sampling in infants Comparison the effect of breastfeeding and oral glucose (10%) on the severity of pain and physiologic characteristics due to venous sampling in infants who Hospitalized in neonatal intensive care unit 2019-02-20 anticipated 135 Complete https://irct.ir/trial/37169 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample will be selected from preterm infants according to inclusion criteria. Thus, blocks will be created based on personal information and inside of each block will be divided to three equal parts. Each part is assigned to intervention group 1, intervention group 2 and control group, respectively. N/A Condition 1: Physiological responses. Condition 2: pain. Intervention 1: Intervention group 1: this group will be embraced the mother and they will be eaten breast milk. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire. Intervention 2: Intervention group 2: this group will be embraced the mother and they will be eaten oral 10% glucose. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire. Intervention 3: Control group: this group will be embraced the mother and will not perform any intervention. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire. No - There is not a plan to make this available Justification or reason for not sharing IPD is Relied on secrecy
public Mojgan Saeidinejad
No 8., Esteghlal st.,
Kerman Iran (Islamic Republic of) 7617795988 +98 34 3247 2508 m.saedinejad@kmu.ac.ir Kerman University of Medical Sciences scientific Mojgan Saeidinejad
No 8., Esteghlal st.,
Kerman Iran (Islamic Republic of) 7617795988 +98 342472508 m.saedinejad@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Gestational age more than 30 weeks Lack of congenital anomalies Lack of mechanical ventilation 1 day 28 days Both Having nutritional problems receive sedatives three hours before intervention G89.18 Other acute postprocedural pain Other Other Other Intervention group 1: this group will be embraced the mother and they will be eaten breast milk. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire. Intervention group 2: this group will be embraced the mother and they will be eaten oral 10% glucose. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire. Control group: this group will be embraced the mother and will not perform any intervention. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire. Arterial oxygen saturation. Timepoint: Before, during and after intervention. Method of measurement: Pulseoximetery. Pulse rate. Timepoint: Before, during and after intervention. Method of measurement: Pulseoximetery. Pain. Timepoint: During intervention. Method of measurement: NIPS Questionnaire. Kerman University of Medical Sciences Approved 2018-12-15 Ethics committee of Kerman University of Medical Sciences Campus of Kerman medical science university,Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)