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IRCT20241029063534N1 IRCT 2025-03-20 Yazd University of Medical Sciences Investigating the effect of the smell of Rosa damascena on suction pain in infants ندارد The effect of aromatherapy with Rosa damascena on pain during airway suctioning of infants admitted to neonatal intensive care 2025-03-21 anticipated 62 Complete https://irct.ir/trial/80299 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible infants will be selected and then through a simple random method divided into two equal groups. A table of numbers from 1 to 62 will be prepared, with the intervention group labeled as A and the control group as C .Thirty one papers marked with the letter A and thirty one papers marked with the letter C will be placed in an envelope. For each number in the table, one paper will be drawn from the envelop until the last number is reached. This process ensures randomization, Blinding description: In this study, each infant will be assigned to one of two groups (intervention or control ) based on a randomization table. During the suctioning process a video will be recorded of the infant using a Samsung mobile phone. The pain score is evaluated based on the pain criterion in the newborns in both groups before, during, and 2 minutes after the suction based on the video taken by the research colleague who does not know about the groups (outcome assessor). 3 Pain during airway suctioning in infants. Intervention 1: Intervention group: 31 infant in this group, from 3 minutes before the beginning of suction to 2 minutes after the end of suction, the airways were under aromatherapy with 2 drops of 10% rosehip essential oil made by Ide Daru Pars Company, which was poured on a cotton ball and a distance of 3 cm from the infant's nose. In both groups, the infant is placed in a lying position on the back and the head is placed in a non-rotating position. In both groups, due to the presence of secretions in the babies receiving CPAP with a nasopharyngeal tube, the oropharynx area will be suctioned once and then the nasopharynx area once, and during suctioning, the baby will be filmed using a Samsung mobile phone. Suction will be done using a 6 or 8 french catheter and the pressure of the device will be less than 80 mmHg. The suction time will be less than 6 seconds. Intervention 2: Control group: Infants were exposed 2 drops of sterile distilled water from a 5 ml vial (produced by Shahid Ghazi Pharmaceutical Company), poured onto a cotton pad and placed 3 cm away from the infant 's nose, from 3 minutes before until 2 minutes after the completion of suctioning. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Saeede Karamshahi
SHahid Dadalhi Alley-Aliabad Sazeman
Jiroft Iran (Islamic Republic of) 7861410043 9834436336 saeedekaramshahi@gmail.com Yazd University of Medical Sciences scientific Saeede Karamshahi
SHahid Dadalhi Alley-Ali Abad Sazeman
Jiroft Iran (Islamic Republic of) 7861410043 034436336 saeedekaramshahi@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) mother's consent for the newborn to participate in the research Newborns on respiratory support with a non-invasive method with a nasopharyngeal tube (NCPAP) with a gestational age of 27 to 37 weeks Confirmation of the absence of olfactory problems in the newborn by a specialist doctor no systemic disease or early anomalies. Having an Apgar score higher than and equal to 7 at the time of birth, Birth weight above 1000 grams The baby being calm and awake Not taking acetaminophen or any other painkillers. 4 hours before the suction procedure The temperature is between 36 and 37.5 The absence of hypoglycemia The absence of previous painful interventions such as circumcision, vein ligation 1 day 28 days Both Infants with congenital anomalies and diseases Infants who do not have stable vital signs N/A N/A Intervention group: 31 infant in this group, from 3 minutes before the beginning of suction to 2 minutes after the end of suction, the airways were under aromatherapy with 2 drops of 10% rosehip essential oil made by Ide Daru Pars Company, which was poured on a cotton ball and a distance of 3 cm from the infant's nose. In both groups, the infant is placed in a lying position on the back and the head is placed in a non-rotating position. In both groups, due to the presence of secretions in the babies receiving CPAP with a nasopharyngeal tube, the oropharynx area will be suctioned once and then the nasopharynx area once, and during suctioning, the baby will be filmed using a Samsung mobile phone. Suction will be done using a 6 or 8 french catheter and the pressure of the device will be less than 80 mmHg. The suction time will be less than 6 seconds. Control group: Infants were exposed 2 drops of sterile distilled water from a 5 ml vial (produced by Shahid Ghazi Pharmaceutical Company), poured onto a cotton pad and placed 3 cm away from the infant 's nose, from 3 minutes before until 2 minutes after the completion of suctioning. Suction pain. Timepoint: 3 minutes before suction and during and 2 minutes after suction. Method of measurement: Neonatal Infant Pain Scale. The neonatal's heart rate. Timepoint: Three minutes before the start of suction and during and two minutes after suction. Method of measurement: Pulse oximetry. Blood oxygen saturation percentage. Timepoint: Three minutes before the start of suction and during and two minutes after suction. Method of measurement: Pulse oximetry. Yazd University of Medical Sciences Approved 2024-10-09 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Vice-Chancellor of Research and Technology, Shahid Sadoughi University of Medical Sciences-Student Blvd-Imam Hossein Square -Yazd Yazd Yazd Iran (Islamic Republic of)