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IRCT20201020049088N1 IRCT 2020-11-15 Kerman University of Medical Sciences The effects of aromatherapy on the anxiety and sleep quality of the patients with COVID-19 The Investigation of effects of aromatherapy with lavender extract in comparison with placebo on the anxiety and sleep quality of the patients with COVID-19 2020-11-05 anticipated 60 Complete https://irct.ir/trial/51748 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block random allocation is used to assign the subjects to the intervention and control groups. In this method, blocks of size 4 are used, in each block two participant are in the intervention group and two participant are in the control group, Blinding description: Blindness in this study is single blind, so that the statistician is not aware of the study groups and the data analyst does not know which data is related to the intervention group and which data is related to the control group. N/A COVID-19. Intervention 1: Intervention group: includes aromatherapy with lavender essential oil (Zardband company) for the intervention group. The intervention in 3 consecutive nights and lasts 20 minutes each night; For aromatherapy, 2 drops of 2% lavender essential oil will be dropped on a napkin and will be attached it to the patient's clothes near the nose. Intervention 2: Control group: on 3 consecutive nights and every night for 20 minutes; 2 drops of distilled water will be dropped on a napkin and will be attached it to the patient's clothes near the nose. 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 The researcher doesn't have any interest to share because of ethical issues. ( there​ is No further information)
public Behnaz Bagherian
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 behnaz_bag@yahoo.com Kerman University of Medical Sciences scientific Behnaz Bagherian
Medical University Campus, Kerman University of Medical Sciences, Haft- Bagh- Alavi highway
kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 behnaz_bag@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Confirmed COVID-19 Physical and mental ability to answer questions Ability to understand and speak Persian Being able to give informed consent 18 years 65 years Both Absence of healthy sense of smell Having a history of allergy to lavender essential oil Having severe dyspnea Use of sedatives and anti-anxiety drugs Suffering from sleep disorders, depression and anxiety before illness U07.1 COVID-19, virus identified N/A Other Intervention group: includes aromatherapy with lavender essential oil (Zardband company) for the intervention group. The intervention in 3 consecutive nights and lasts 20 minutes each night; For aromatherapy, 2 drops of 2% lavender essential oil will be dropped on a napkin and will be attached it to the patient's clothes near the nose. Control group: on 3 consecutive nights and every night for 20 minutes; 2 drops of distilled water will be dropped on a napkin and will be attached it to the patient's clothes near the nose. Anxiety. Timepoint: Before the intervention and after the intervention for 3 consecutive nights. Method of measurement: Spielberger state- trait anxiety. Sleep quality. Timepoint: Before the intervention and on the morning of the fourth day at the end of the intervention. Method of measurement: Verran and Snyder-Halpern Sleep Scale. Kerman University of Medical Sciences Approved 2020-10-20 Ethics Committee of Kerman University of Medical Sciences Medical University Campus; Kerman University of Medical Sciences; Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)