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IRCT20210523051370N3 IRCT 2021-08-21 Mazandaran University of Medical Sciences Effect of aromatherapy with Citrus Aurantium essence on sleep quality and anxiety “The effect of inhalation aromatherapy with Citrus Aurantium essence on sleep quality and anxiety of patients with acute coronary syndrome” 2021-09-20 anticipated 84 Complete https://irct.ir/trial/56626 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: As patients will be recruited from several hospital wards, they will be divided into two groups, one control group (randomly divided into two subgroups) receiving aromatherapy with pure paraffin; one experimental group (randomly divided into two subgroups) receiving aromatherapy with 30% Citrus Aurantium essence) to reduce the impact of confounding variables. First, a comparison will be made between the two control subgroups as well as the two experimental subgroups. If there will be no difference between the two control subgroups and also between the two experimental subgroups, the final comparison between the experimental and control groups will be made. Otherwise, the CCU variable is considered as a moderating variable in the study and subsequently, a statistical analysis of the comparison between the two groups will be performed, Randomization description: The study design consists of an experimental group and a control group. Patients will be recruited using convenience sampling method and then will be randomly assigned to four groups by block randomization method. A quadruple block (A, B, C, D) will form letters A and B of the control group , the letters C and D of the patient to the experimental group. Using the letters A, B, C and D, 24 blocks of four are formed, which will be numbered from one to 24. Then, using Random Number Generator software, 21 numbers are selected from numbers 1 to 24. patients will be divided into two groups (one control group receiving aromatherapy with pure paraffin; one experimental group receiving aromatherapy with 30% Citrus Aurantium essence), Blinding description: The assessor will not be part of the research team and will be blind to participant allocation to study groups. The sharpness of the smell of aroma oil will be suppressed by adding a little oil to a face mask to be worn by the assessor during measurements. N/A anxiety and sleep quality. Intervention 1: Experimental group : The duration of aromatherapy is two consecutive nights and from 9 pm, after receiving the routine care, in experimental groups one and two, 1.5 cc of 30% citrus aurantium essential oil (prepared by Noorhan Pharmaceutical Company, Shiraz, Iran, is poured on a cotton ball with a syringe and the patient is asked to take three deep breaths and then the cotton ball will be attached to the patient's collar. In the morning (7 o'clock in the morning), cotton ball will be removed from the collar of the patient's clothes. Intervention 2: Control group: The duration of aromatherapy is two consecutive nights and from 9 pm, after receiving the routine drugs of the ward, in control groups one and two, 1.5 cc of pure paraffin (prepared by Fadak Shimi Toos Company, Mashhad, Iran, is poured on a cotton ball with a syringe and the patient is asked to take three deep breaths and then the cotton ball will be attached to the patient's collar. In the morning (7 o'clock in the morning), cotton ball will be removed from the collar of the patient's clothes. 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 All data will be kept confidential
public Dr. Seyed Afshin Shorofi
Imam Square, Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4815733971 +98 11 3633 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences scientific Dr. Seyed Afshin Shorofi
Vesal St., Nasibeh School of Nursing and Midwifery
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 years and older At least 24 hours have passed since admission to cardiac care unit Acute coronary syndrome diagnosed by treating physician Stability of vital signs No addiction to drugs and alcohol No mental disorders (such as Down syndrome and dementia) No history of hospitalization due to mental disorders Not experienced stressful events in the last 6 months (except for events related to their heart disease) Willingness to participate in the study 18 years no limit Both Pregnancy Breastfeeding History of allergies to essential oils and perfumes Acute respiratory diseases Shortness of breath and chronic cough F06.4 Anxiety disorder due to known physiological condition N/A Placebo Experimental group : The duration of aromatherapy is two consecutive nights and from 9 pm, after receiving the routine care, in experimental groups one and two, 1.5 cc of 30% citrus aurantium essential oil (prepared by Noorhan Pharmaceutical Company, Shiraz, Iran, is poured on a cotton ball with a syringe and the patient is asked to take three deep breaths and then the cotton ball will be attached to the patient's collar. In the morning (7 o'clock in the morning), cotton ball will be removed from the collar of the patient's clothes. Control group: The duration of aromatherapy is two consecutive nights and from 9 pm, after receiving the routine drugs of the ward, in control groups one and two, 1.5 cc of pure paraffin (prepared by Fadak Shimi Toos Company, Mashhad, Iran, is poured on a cotton ball with a syringe and the patient is asked to take three deep breaths and then the cotton ball will be attached to the patient's collar. In the morning (7 o'clock in the morning), cotton ball will be removed from the collar of the patient's clothes. Anxiety. Timepoint: Basic (before intervention time: time zero), follow-up (after the end of two nights of intervention and in the morning of the third day: time two). Method of measurement: Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A). Sleep quality. Timepoint: Basic (before intervention time: time zero), follow-up (after the end of two nights of intervention and in the morning of the third day: time two). Method of measurement: Schneider-Halpren Sleepers Scale. Mazandaran University of Medical Sciences Approved 2021-05-11 Biothics Committee of Mazandaran University of Medical Sciences Sari, Moallem Square, Deputy of Research and Technology Sari Mazandaran Iran (Islamic Republic of)