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IRCT20171007036599N4 IRCT 2020-07-25 Zahedan University of Medical Sciences The effect of aromatherapy with Rosa ِdamascenes on the sleep state of premature neonates The effect of aromatherapy with Rosa damascenes on the sleep state of premature neonates admitted to the neonatal intensive care unit of Ali ebne Abitaleb hospital in Zahedan ,2020 2020-10-05 anticipated 64 Complete https://irct.ir/trial/44937 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The permuted block stratified randomization method will be used. The stratified randomization method allows the elimination of possible heterogeneities between the two groups in terms of age and sex. Also, the block randomization method provides the possibility of creating a balance in the number of samples assigned to each of the study groups. The randomization method is that the participating infants are classified at the beginning of the arrival in terms of age (30-33 and 33-37 weeks) and sex (girl-boy). In the next step, the infants will be assigned individually to group A or B according to the quadruple blocks. Random sequence of quadruple blocks will be selected as ABAB / ABBA / BAAB / BABA / AABB / BBAA from the random number table. The classification and blocking process will continue until the study sample size is reached, Blinding description: In this research,sampling and intervention will be done with the help of the researcher. All interventions will be recorded by the video camera . First, the researcher will be placed on the newborn's bed to evaluate and complete the form while examining the infant's sleep status and then the researcher will review the film's information to confirm the accuracy and the final score will be given. Researchers are unaware of the newborn's sleeping position on the newborn's bed , as well as the researcher's help when watching the recorded video of the intervention and control group. N/A Premature neonate's sleep. Intervention 1: Intervention group:The baby is placed embryonically in the nest inside a double-walled incubator. The type of sleeping position of the baby within 20 minutes, according to the Ales tool, is determined every 2 minutes before, during and after placing the pad soaked in Zahra's organic rose at a distance of 30 cm from the baby's head and is recorded in the table. Intervention 2: Control group:The baby is placed embryonically in the nest inside a double-walled incubator. The type of sleeping position of the baby within 20 minutes, according to the Ales tool, is determined every 2 minutes before, during and after placing the pad soaked in" Distilled water" at a distance of 30 cm from the baby's head and is recorded in the table. Yes - There is a plan to make this available What will be shared: The main outcomes of the participants are public. When: The main outcomes of the participants are public. To whom: The researchers in academic and scientific institutions. Conditions: The statistical result. Where to obtain: Faculty of Nursing and Midwifery, Zahedan Telephone: 05433442481 Postcode: 9816913396 Address: Mashahir Square, Nursing and Midwifery Faculty, Zahedan How to obtain: Contact the Nursing Faculty Library section. Comments: does not have.
public Fereshteh Ghaljaei
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
Zahedan Iran (Islamic Republic of) 9816913396 +98 54 3344 2481 Ghaljaei-f@zaums.ac.ir Zahedan University of Medical Sciences scientific Fereshteh Ghaljaei
Mashahir square, Faculty of Nursing and Midwifery, Zahedan
Zahedan Iran (Islamic Republic of) 9816913396 +98 54 3344 2481 Ghaljaie-f@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Age between 30 and 37 fetal weeks Sustainable physiological symptoms Lack of severe respiratory distress No history of drug abuse in the mother Completion of the infant consent form for participation in research by parents 1 day 28 days Both Having a chest tube and a umbilical catheter Use of narcotic, sedative and anesthetic drugs for the neonate Having diseases: icterus, congenital neurological abnormalities, meningitis, seizures, encephalopathy and interstitial hemorrhage P07.0 Extremely low birth weight newborn Treatment - Drugs Placebo Intervention group:The baby is placed embryonically in the nest inside a double-walled incubator. The type of sleeping position of the baby within 20 minutes, according to the Ales tool, is determined every 2 minutes before, during and after placing the pad soaked in Zahra's organic rose at a distance of 30 cm from the baby's head and is recorded in the table. Control group:The baby is placed embryonically in the nest inside a double-walled incubator. The type of sleeping position of the baby within 20 minutes, according to the Ales tool, is determined every 2 minutes before, during and after placing the pad soaked in" Distilled water" at a distance of 30 cm from the baby's head and is recorded in the table. Sleep status of preterm neonate. Timepoint: During 20 minutes before the intervention, 70 minutes during intervention and 20 minutes after the intervention. Method of measurement: Observation the behavior of neonate with use of sleep and waking scale of Als, by researcher and helpre. Physiological signs of the neonate. Timepoint: Before, during and after the intervention. Method of measurement: Pulse oximetry. Zahedan University of Medical Sciences and Health Services Approved 2019-11-18 Ethics Committee of Zahedan University of Medical Sciences Dr. Hassabi Square, Janat Blvd, Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)