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IRCT20090810002324N16 IRCT 2020-06-06 Iran University of Medical Sciences Aromatherapy and orientation tour on anxiety, stress and depressed mood The effect of aromatherapy and orientation tour on anxiety, stress, and depressed mood in mothers of preterm infants 2020-07-31 anticipated 126 Complete https://irct.ir/trial/47469 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Blinding description: All questionnaires at all stages, will be gathered by the research assistant who is unaware of the groups' allocation. N/A The state and trait anxiety, stress, depressed mood. Intervention 1: Orientation tour: At first, four drops of distilled water, as a placebo, will be dripped on a pad and attached to the mother’s collar of clothes. The mother will inhale it normally for 30 minutes. After removing the pad, the mother and the researcher will enter into the neonatal intensive care unit (NICU) for the first time. Then the orientation tour will be individually held for the mother in a 30- minute section. The mother will be familiarized with the NICU by brief and understandable explanations about equipment such as ventilator, incubator, phototherapy set, pulse oximeter, monitor, warmer and other devices. Employees will be introduced and rules in the NICU will also be explained. At the end of intervention’s day, the mothers of this group will re-inhale pad which drips with four drops of distilled water, for 30 minutes before bedtime. Intervention 2: Aromatherapy and Orientation tour: At first, four drops of 2% orange essence (made by the Barij Essence Pharmaceutical Company) will be dripped on a pad and attached to the mother’s collar of clothes. The mother will inhale it normally for 30 minutes. After removing the pad, the mother and the researcher will enter into the neonatal intensive care unit (NICU) for the first time. Then the orientation tour will be individually held for the mother in a 30- minute section. The mother will be familiarized with the NICU by brief and understandable explanations about equipment such as ventilator, incubator, phototherapy set, pulse oximeter, monitor, warmer and other devices. Employees will be introduced and rules in the NICU will also be explained. At the end of intervention’s day, the mothers of this group will re-inhale pad, which drips with four drops of 2% orange essence, for 30 minutes before bedtime. Intervention 3: Control group: The control group will meet their baby for the first time in the usual way, and all schedules for completing the questionnaires in this group will be included. None of the aromatherapy and orientation tour methods will be performed for this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decisions will be made in the future
public Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1813 Keshavarz.m@iums.ac.ir Iran University of Medical Sciences scientific Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1813 keshavarz.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iranian primiparous women Single Pregnancy Pregnancy age 30 - 36 weeks First entry into the neonatal intensive care unit Ability to at least read and write Respiratory distress in the newborn 18 years 40 years Female Substance-abusing (cigarettes, alcohol, and psychotropics) The problem of smell, respiratory diseases, sensitivity to the orange aroma Use of herbal oils and sedatives at least six weeks before the intervention Mental illness (according to the personal reporting) History of recurrent miscarriage or infertility Congenital anomaly in newborn The referred newborn from other hospitals Apgar score of 6 or less at minutes 5 Prevention Prevention N/A Orientation tour: At first, four drops of distilled water, as a placebo, will be dripped on a pad and attached to the mother’s collar of clothes. The mother will inhale it normally for 30 minutes. After removing the pad, the mother and the researcher will enter into the neonatal intensive care unit (NICU) for the first time. Then the orientation tour will be individually held for the mother in a 30- minute section. The mother will be familiarized with the NICU by brief and understandable explanations about equipment such as ventilator, incubator, phototherapy set, pulse oximeter, monitor, warmer and other devices. Employees will be introduced and rules in the NICU will also be explained. At the end of intervention’s day, the mothers of this group will re-inhale pad which drips with four drops of distilled water, for 30 minutes before bedtime. Aromatherapy and Orientation tour: At first, four drops of 2% orange essence (made by the Barij Essence Pharmaceutical Company) will be dripped on a pad and attached to the mother’s collar of clothes. The mother will inhale it normally for 30 minutes. After removing the pad, the mother and the researcher will enter into the neonatal intensive care unit (NICU) for the first time. Then the orientation tour will be individually held for the mother in a 30- minute section. The mother will be familiarized with the NICU by brief and understandable explanations about equipment such as ventilator, incubator, phototherapy set, pulse oximeter, monitor, warmer and other devices. Employees will be introduced and rules in the NICU will also be explained. At the end of intervention’s day, the mothers of this group will re-inhale pad, which drips with four drops of 2% orange essence, for 30 minutes before bedtime. Control group: The control group will meet their baby for the first time in the usual way, and all schedules for completing the questionnaires in this group will be included. None of the aromatherapy and orientation tour methods will be performed for this group. The score of state anxiety. Timepoint: One hour before the mother's first visit to the neonatal intensive care unit (NICU), an hour after leaving the ward, Twenty-four hours after the intervention. Method of measurement: The state anxiety of Spielberger questionnaire. The score of trait anxiety. Timepoint: One hour before the mother's first visit to the NICU, an hour after leaving the ward, Twenty-four hours after the intervention. Method of measurement: The trait anxiety of Spielberger questionnaire. The score of parental stress. Timepoint: Twenty-four hours after the intervention. Method of measurement: The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). The score of depressed mood in the Profile of Mood States Questionnaire (POMS) (McNair). Timepoint: One hour before the mother's first visit to the NICU, twenty-four hours after the intervention. Method of measurement: Depressed mood in the Profile of Mood States Questionnaire (POMS) (McNair). Iran University of Medical Sciences Approved 2020-05-27 Ethic committee of Iran University of Medical sciences Iran University of Medical Sciences, Milad Tower, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)