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IRCT20250712066456N1 IRCT 2025-09-04 Mashhad University of Medical Sciences The Effect of Lavender Aromatherapy on the Behavioral Reactions of Preterm neonate in the neonatal intensive care unit. The Effect of Lavender Aromatherapy on the Behavioral Reactions of Preterm neonate in the neonatal intensive care unit. 2025-09-23 anticipated 86 Complete https://irct.ir/trial/84775 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the sequence of random allocation of individuals to the studied groups uses the method of replaced blocks and software Random Allocation Software. Due to the sample size of 43 cases per group, the first of the six possible blocks of four blocks of four "AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6)" was selected by accident and then the individuals were assigned to Group B and A. For example, if the first block, ABBA, is selected, the first and fourth person will be assigned to Group A and the second and third to Group B. This will continue until the sample size is completed. The characteristic of this method is that the two study groups will have equal number, Blinding description: It is inserted into the incubator to blind the aroma by a person. Group A is the intervention group and group B control. Due to the random sequence selected, the fragrance is inserted for one hour. Babies are kept in the incubator, which is a completely closed environment and there is no fragrance release. After an hour of evaluation, the evaluation of the neonates under study and scores the behavioral reaction of infants. The statistical analyst will also perform the analysis and interference without knowing the control group. 3 Behavioral reaction of premature neonate. Intervention 1: Intervention group: : The scent of lavender is placed ten centimeters away from the baby's head for one hour. The behavioral response of the infants will be observed for 30 seconds once before placing the lavender scent in the incubator, and twice after the aromatherapy is completed, once immediately after the aromatherapy is completed, and the second time half an hour after the aromatherapy is completed, and will be determined using the Anderson tool and recorded in a table. The study will be conducted from 3:00 PM to 5:00 PM, after feeding and routine nursing care, to minimize confounding factors. During the study, the infants' breathing rate and heart rate will be monitored to maintain patient safety.We dissolve one drop of 100% water-soluble lavender essential oil from the company Gaya Kala with 4 cc of warm distilled water and use it. The concentration of the solution obtained will be one percent.Linalool and linalyl acetate are the two main ingredients effective in calming.Dilution will be performed using standard droppers in the laboratory. Intervention 2: Control group: In routine conditions and according to the intervention group's schedule, the behavioral response of premature infants will be recorded according to the Anderson instrument. This study will be conducted after feeding and routine nursing care, from 3:00 PM to 5:00 PM in order to reduce confounding factors. During the study, the respiratory rate and heart rate of the infants will be monitored to maintain patient safety. . Yes - There is a plan to make this available What will be shared: The behavioral response of premature infants, which is the main outcome of this study, will be presented. When: After the publication of the article To whom: Academic and industrial researchers Conditions: Academic and industrial researchers Where to obtain: Maedeh Rababi, Master's student, Mashhad School of Nursing, Pediatric and Neonatal Department How to obtain: Send your request via email, it will be responded to as soon as possible. Comments:
public MAEDEH ROBABI
delavaran 21
Mashhad Iran (Islamic Republic of) 9177138738 +98 51 3822 4906 robabim4022@mums.ac.ir Mashhad University of Medical Sciences scientific naghme razaghi
Ferdowsi University, Shahid Kharazmi Complex
Mashhad Iran (Islamic Republic of) 9177949025 +98 51 3859 1511 Razaghin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of newborns 28-34 weeks of pregnancy Apgar score at birth at 5 minutes above 6 Lack of various neonatal anomalies The baby has not had an invasive procedure performed on him/her within the last 2 hours. Having stable vital signs 1 day 28 days Both Edict's mother Gestational age greater than 34 weeks Using narcotics and sedatives for the baby Intubate neonate Nasal cannula neonate. Behavior Behavior Intervention group: : The scent of lavender is placed ten centimeters away from the baby's head for one hour. The behavioral response of the infants will be observed for 30 seconds once before placing the lavender scent in the incubator, and twice after the aromatherapy is completed, once immediately after the aromatherapy is completed, and the second time half an hour after the aromatherapy is completed, and will be determined using the Anderson tool and recorded in a table. The study will be conducted from 3:00 PM to 5:00 PM, after feeding and routine nursing care, to minimize confounding factors. During the study, the infants' breathing rate and heart rate will be monitored to maintain patient safety.We dissolve one drop of 100% water-soluble lavender essential oil from the company Gaya Kala with 4 cc of warm distilled water and use it. The concentration of the solution obtained will be one percent.Linalool and linalyl acetate are the two main ingredients effective in calming.Dilution will be performed using standard droppers in the laboratory. Control group: In routine conditions and according to the intervention group's schedule, the behavioral response of premature infants will be recorded according to the Anderson instrument. This study will be conducted after feeding and routine nursing care, from 3:00 PM to 5:00 PM in order to reduce confounding factors. During the study, the respiratory rate and heart rate of the infants will be monitored to maintain patient safety. . Behavioral Reactions of Preterm neonate. Timepoint: Before the intervention, immediately after the intervention, half an hour after the intervention. Method of measurement: Anderson Behavioral Scale system.(ABSS). Mashhad University of Medical Sciences Approved 2025-07-15 Ethics committee of mashhad University Medical science Ferdowsi University kharazmi complex Mashhad Razavi Khorasan Iran (Islamic Republic of)