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IRCT20221026056310N1 IRCT 2022-11-21 Tehran University of Medical Sciences Investigating the effectiveness of lavender scent inhalation on fatigue and stress of mothers of premature babies The effect of inhaling Lavender scent on fatigue and stress of mothers of premature infants admitted to neonatal intensive care unit 2022-11-22 anticipated 72 Complete https://irct.ir/trial/66510 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, we put the studied hospitals (Medical Center, Bahrami, Shariati, Valiasr, Yas, Baharlo and Arash hospitals) into two intervention and control groups through lottery. Then, in the mentioned hospitals, based on the entry criteria and exit criteria, we consider a number of mothers of premature babies as the statistical population. In the next step, we assign a unique number to each of the mothers and put the numbers in a bag. Based on the lottery, we draw numbers until we reach the desired sample size in each of the intervention and control groups. 3 Stress and fatigue of mothers of premature babies hospitalized in neonatal intensive care unit. Intervention 1: Intervention group: In this study, lavender essential oil (Lavandula angustifolia) produced by Zardband Yasouj Company - Iran, which is prepared from the flowering branches of the plant and contains 45% linalool, will be used. This substance is inhaled by mothers of premature babies through a neck pendant. This neck pendant is placed at a distance of 20 cm from the nose and inhaled with a dose of two drops for 4 weeks every other day for 30 minutes. Intervention 2: Control group: No aromatherapy is performed in the control group. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: 3 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Researchers are allowed to use the results of the data for use in future articles. Where to obtain: Azita Ghorbani, contact number 0098 9180857399, E-mail address: Trasib54@gmail.com, North Kargar St., in front of 16th St., Tehran University of Medical Sciences Girls' Dormitory, Postal code 1439957181 How to obtain: The applicant can send his request by e-mail. If you wish, the data will be sent to them after 3 days. Comments:
public Azita Ghorbani
North Kargar St, in front of 16th St, Koi complex Tehran university of medical sciences
Tehran Iran (Islamic Republic of) 1439957181 +98 21 8801 6071 Trasib54@gmail.com Tehran University of Medical Sciences scientific Azita Ghorbani
North Kargar St, in front of 16th St, Koi complex Tehran university of medical sciences
Tehran Iran (Islamic Republic of) 1439957181 +98 21 8801 6071 Trasib54@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Having a baby in the neonatal intensive care unit No history of neurological and mental illness No history of allergies and respiratory disorders No history of drug use (anti-anxiety, anti-stress and anti-depressant) willingness to participate in the study Avoid drinking caffeinated beverages one hour before the intervention (due to the close relationship between insomnia and fatigue). The age of the baby is between 30 and 37 weeks Absence of congenital malformation of the baby no limit no limit Female Death of a baby Creating postpartum depression The smell of lavender is unpleasant for the mother Causing allergic reactions such as headache, nausea and other allergic symptoms for the mother F54 Psychological and behavioral factors associated with disorders or diseases classified elsewhere Other N/A Intervention group: In this study, lavender essential oil (Lavandula angustifolia) produced by Zardband Yasouj Company - Iran, which is prepared from the flowering branches of the plant and contains 45% linalool, will be used. This substance is inhaled by mothers of premature babies through a neck pendant. This neck pendant is placed at a distance of 20 cm from the nose and inhaled with a dose of two drops for 4 weeks every other day for 30 minutes. Control group: No aromatherapy is performed in the control group. Fatigue score in Multidimensional Fatigue Measurement Questionnaire. Timepoint: (before the start of the intervention) and 14 and 28 days after the start of the intervention. Method of measurement: Multidimensional fatigue measurement questionnaire. The Multidimensional Fatigue Measurement Questionnaire is a 20-item self-report tool that provides a deeper and more accurate understanding of a person's fatigue by evaluating 5 dimensions. The multidimensional fatigue measurement questionnaire has 5 areas: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), activity-related fatigue (4 items) and decreased motivation (4 items). In the fatigue questionnaire, people are measured both in the physical dimension and in the mental dimension. The answer range for each question was a 5-point Likert scale ranging from "yes, completely true" to "no, completely false". Stress score in parental stress questionnaire in neonatal special care unit. Timepoint: (before the start of the intervention) and 14 and 28 days after the start of the intervention. Method of measurement: Parental stress questionnaire in neonatal special care unit. The parental stress questionnaire in the neonatal intensive care unit is a 34-item self-report tool that is used to measure parents' perception of stress in the neonatal intensive care unit. In this questionnaire, there are three subscales that include stress related to: 1- the sights and sounds of the neonatal intensive care unit environment (6 items), 2- the appearance and behavior of the baby and the special treatments performed on the baby (17 items). and 3- parents' relationship with the baby and parental roles (11 items). Answers were scored on a 5-point Likert scale with "1" being "no stress" and "5" being "extremely stressful". A higher score in this questionnaire indicates more stress experience. Tehran University of Medical Sciences Approved 2022-09-27 Working Group/Committee Ethics in Research Faculty of Nursing and Midwifery and Faculty of Rehabilit End of Kargar North, in front of Masjid al-Nabi, Koi Complex for Girls of Medical Sciences, Tehran Tehran Tehran Iran (Islamic Republic of)