Healing Aromas: The Effects of Lavender and Rosemary Essential Oils on Sleep Quality and Mental Well-Being in Coronary Artery Disease Patients: a Parallel Arm, Randomized, Controlled Trial

Comparing the Effect of Lavender and Rosemary Essential Oil Inhalation and the Simultaneous Use of These Two Scents on Sleep Quality, Anxiety and Depression in Patients Suffering from Coronary Artery Disease

This single-blind randomised clinical trial study will have three intervention groups (lavender aromatherapy, rosemary aromatherapy and simultaneous aromatherapy with these two aromas) and a control group. The study phase is not applicable here. The randomization method will be block randomization on 148 patients.

Amol, Iran. single-blind (the data analyst and researcher will be blinded but the data collector and samples will not be blinded). The samples will be randomly divided into three intervention groups and one control group and will be exposed to the aromatic substance three times a day for 20 minutes by pouring 4 drops of the relevant aromatic oil on a piece of gauze and attaching it to the collar. It is done for 30 consecutive days. In the simultaneous aromatherapy group, two drops of lavender oil and two drops of rosemary oil and in the control group, a saline solution will be used.

Entry conditions: suffering from coronary artery disease, obtaining scores of greater than five from the PSQI sleep quality index, able to read and write, EF above 45%, access to social networks Conditions not to enter: having a history of asthma, active mental illness, taking neuropsychiatric drugs, allergies to plants or any seasonal sensitivity, severe pain causing sleep disturbance, smell disturbance

Aromatherapy with lavender, rosemary, Simultaneous aromatherapy with these two scents and control.

Anxiety, depression and sleep quality

The title of the trial was modified due to an effort to choose a more attractive title for publication in reputable journals. The sample size was reduced to 120 samples due to the lack of financial budget and the time limit in carrying out the project. The timing of sampling was changed according to the changes made in the schedules of the respective universities. The end time of the clinical trial was added. By reviewing more literature, a saline solution (0.9% sodium chloride) was used instead of distilled water in the control group.

Eligible people will be selected by the available method and will be placed in three intervention groups and one control group using block randomization method. For this purpose, 37 blocks of 4 will be allocated using www.randomizer.org website, and each block will have 4 random numbers from 1 to 4. Then these blocks will be written on paper and sealed and then randomly one block will be chosen at each turn and people will enter the study in the order written on the paper. In fact, one block of four out of every 37 blocks of four will be randomly selected and the patients, as specified in the block, will divided into these groups: aromatherapy with lavender (1), aromatherapy with rosemary (2), simultaneous aromatherapy with these two aromas (3) and control (4). In this way, four patients (one patient in each group) will be examined each time. For the next time, another block is randomly selected and the patients are divided into one of the four study groups based on the selected block. Some blocks of four will be facing as follows: 2341, 1342, 1234.

In this study, the data analyst and the researcher who evaluates the results will be blinded and unaware of the nature of the groups, but the nurse assessor (data collector) will not be blinded. For this purpose, first of all, bottles containing essential oils and distilled water, which are completely similar in appearance, will be provided to the nurse evaluator, and she will randomly give them to the samples. without the researcher and data analyst knowing the nature of the groupings. It should be noted that the distinctive smell of essential oils makes it difficult to blind the study participants.

All demographic information, sleep quality, depression and anxiety of the samples

accessible from 2024

The data will be accessible to researchers working in academic and scientific institutions.

The data will be used in secondary data analysis or meta-analysis studies.

Address of the University: The Headquarters of Mazandaran University of Medical Sciences and Health Services, the beginning of ValiAsr Highway (AJ), Sari Postal code: 48157-33971 Contact phone numbers: 09811-33044000 and 09811-33044001 Contact number of Research and Technology Unit: 09811-34484800 Email of Research and Technology Unit: pajhoheshi@mazums.ac.ir Assistant of Research and Technology Unit: Dr. Pedram Ebrahimnejad

At first, official request will be sent from the applicant organization to Mazandaran University of Medical Sciences, and if there is no legal prohibition, the information will be provided to the researcher with the coordination and permission of the university's Research and Technology Unit.