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IRCT20120215009014N304 IRCT 2019-09-30 Shahid Beheshti University of Medical Sciences Effect of aromatherapy with Melissa officinalis versus placebo on the sleep quality and physiological indicators in patients admitted at the cardiac care unit Effect of aromatherapy with Melissa officinalis versus placebo on the sleep quality and physiological indicators in patients admitted at the cardiac care unit: a single-blind randomized clinical trial 2019-04-21 anticipated 98 Complete https://irct.ir/trial/42236 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. Thus, the trial will be run as triple blind. N/A Sleep disorder. Intervention 1: Intervention group: Routine treatment as well as aromatherapy with Melissa officinalis for 2 hours twice a day for three consecutive days. Intervention 2: Control group: Routine treatment as well as aromatherapy with placebo prepared by sesame oil for 2 hours twice a day for three consecutive days. 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 It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Adeleh Lotfi
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2521 Adelelotfi2018@gmail.com Tehran University of Medical Sciences scientific Dr Jamileh Mohtashami
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2521 Jmohtashmi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 65 years, Sleep disorder 18 years 65 years Both History of sensitivity to Melissa officinalis, Olfactory sense disorder, History of respiratory allergy or asthma F51.8 Other sleep disorders not due to a substance or known physiological condition Treatment - Drugs Placebo Intervention group: Routine treatment as well as aromatherapy with Melissa officinalis for 2 hours twice a day for three consecutive days Control group: Routine treatment as well as aromatherapy with placebo prepared by sesame oil for 2 hours twice a day for three consecutive days Sleep quality. Timepoint: Before the intervention and 24, 48 and 72 hours after the intervention. Method of measurement: Using the Verran and Snyder-Halpern Sleep Scale. Blood pressure. Timepoint: Before the intervention and 15, 30 and 60 minutes after the intervention. Method of measurement: Using a monitoring machine. Heart rate. Timepoint: Before the intervention and 15, 30 and 60 minutes after the intervention. Method of measurement: Using a monitoring machine. Breathe rate. Timepoint: Before the intervention and 15, 30 and 60 minutes after the intervention. Method of measurement: Using a monitoring machine. Arterial blood oxygen saturation. Timepoint: Before the intervention and 15, 30 and 60 minutes after the intervention. Method of measurement: Using a monitoring machine. Shahid Beheshti University of Medical Sciences Approved 2019-05-05 Ethics Committee of Shahid Beheshti University of Medical Sciences Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences, Danshjou Bul. Tehran Tehran Iran (Islamic Republic of)