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IRCT20200913048704N1 IRCT 2020-10-27 Babol University of Medical Sciences The effect of eye shield and ear muffs on the intensity of venous blood sampling pain in preterm neonates The Effect of Using Eye Shield and Ear Muffs on the Intensity of pain During Venous Blood sampling in Preterm Neonates 2019-11-24 anticipated 148 Complete https://irct.ir/trial/50927 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Health service research, Randomization description: Infants are randomly assigned to each of the four groups of "eye shield", "ear muffs", "ear muffs eye shield" and also "control group". Random allocation will be based on a sequence generated by computer software (QMinim) using the Block randomization with a block size of 4, Blinding description: Intervention groups are infants on whom blood sampling is performed. Infants are unaware of the effects of eye shields and earplugs and are actually blind to the purpose of the study. The analyzer is not aware of the intervention groups and therefore has no bias in interpreting the data. N/A Intensity of pain During Venous Blood sampling in Preterm Neonates. Intervention 1: "Intervention Group1: Eye shield group: Infants who receive eye shield from 15 minutes before injection to 15 minutes after injection". Intervention 2: Control group: infants that does not receive any interventions. Intervention 3: "Intervention group 2: Ear muffs: Infants who receive ear muffs from 15 minutes before injection to 15 minutes after injection". Intervention 4: "Intervention group 3: Ear muffs shield group: Infants who receive both eye shield and ear muffs from 15 minutes before injection to 15 minutes after injection". Yes - There is a plan to make this available What will be shared: The data will be provided to the interested parties in an encoded form in Excel format, taking into account ethical considerations. When: After completing the study To whom: Everyone Conditions: After the publication of the article, all analyzes on the data are allowed by all interested people Where to obtain: Correspond Author How to obtain: By sending an email Comments:
public Ali Zabihi
Babol University of Medical Sciences, Ganjafrooz Street , Babol , Mazandaran ,Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0595 zabihi_alii@yahoo.com Babol University of Medical Sciences scientific Zabihi Ali
Babol University of Medical Sciences, Ganjafrooz Street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0595 zabihi_alii@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Premature infants with a gestational age of 32 to 37 weeks Physiological stability of cardio respiratory (percentage of oxygen saturation above 88%, heart rate between 120 to 160, breath rates between 40 to 60 times per minute No congenital or genetic abnormalities Non use of drugs, antidepressants and anticonvulsants by the mother during pregnancy Not receiving anesthesia and anesthesia drugs Lack of intubation 5 minutes, Apgar score above 7 1 day 28 days Both Prevention Prevention Prevention Prevention "Intervention Group1: Eye shield group: Infants who receive eye shield from 15 minutes before injection to 15 minutes after injection" Control group: infants that does not receive any interventions "Intervention group 2: Ear muffs: Infants who receive ear muffs from 15 minutes before injection to 15 minutes after injection" "Intervention group 3: Ear muffs shield group: Infants who receive both eye shield and ear muffs from 15 minutes before injection to 15 minutes after injection" Intensity of pain during venous blood sampling in preterm infants. Timepoint: 15 minutes before, during and 15 minutes after blood sampling. Method of measurement: Neonatal Infant Pain Scale (NIPS). Infant heart rate changes 15 minutes before, during and 15 minutes after intravenous sampling. Timepoint: 15 minutes before, during and 15 minutes after intravenous sampling. Method of measurement: Cardiorespiratory monitoring device. Changes in infant respiration rate 15 minutes before, during and 15 minutes after intravenous sampling. Timepoint: 15 minutes before, during and 15 minutes after intravenous sampling. Method of measurement: Cardiorespiratory monitoring device. Babol University of Medical Sciences Approved 2019-10-22 Ethics committee of Babol University of Medical Sciences University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran Babol Mazandaran Iran (Islamic Republic of)