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IRCT20230702058649N1 IRCT 2024-02-10 Mazandaran University of Medical Sciences Effects of Lavender and Rosemary Essential Oils on Sleep Quality and Mental Well-Being in Coronary Artery Disease Patients 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 2024-02-20 anticipated 148 Complete https://irct.ir/trial/71060 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Coronary Artery disease. Intervention 1: First intervention group: Aromatherapy with lavender, samples will be exposed to the aromatic substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 4 drops of the relevant aromatic oil (provided by Barijesans Company) on a piece of gauze and attaching it to the patient's collar. This will be done for 30 consecutive days. Intervention 2: second intervention group: Aromatherapy with rosemary, samples will be exposed to the aromatic substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 4 drops of the relevant aromatic oil (provided by Barijesans Company) on a piece of gauze attached to the patient's collar. This will be done for 30 consecutive days. Intervention 3: The third intervention group: Simultaneous aromatherapy with rosemary and lavender, samples will be exposed to the aromatic substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 2 drops of lavender essential oil and 2 drops of rosemary essential oil (provided by Barijesans Company) on a piece of gauze attached to the patient's collar and this will be done for 30 consecutive days. Intervention 4: Control group: Samples will be exposed to the placebo substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 4 drops of saline solution on a piece of gauze and attaching it to the patient's collar and this will be done for 30 consecutive days. Yes - There is a plan to make this available What will be shared: All demographic information, sleep quality, depression and anxiety of the samples When: accessible from 2024 To whom: The data will be accessible to researchers working in academic and scientific institutions. Conditions: The data will be used in secondary data analysis or meta-analysis studies. Where to obtain: 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 How to obtain: 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. Comments:
public Fatemeh Ahmadjani
No.8 Keshavarz Alley, Keshavarz Blvd, Babol
Babol Iran (Islamic Republic of) ۴۷۱۶۱۴۱۷۷۶ +98 11 3223 1149 Fateme.Ahmadjanii@gmail.com Mazandaran University of Medical Sciences scientific Fateme Ahmadjani
No 161, Keshavarz8 Alley, keshavarz Blvd, ganjafrooz Road
Babol Iran (Islamic Republic of) 4716141776 +98 11 3223 1149 F.ahmadjani@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Being diagnosed with coronary artery Disease Having no history of neuropsychiatric disease by self report Having no history of taking psychiatric medications Normal olfactory function Not using benzodiazepines, sedatives and narcotics No history of asthma No history of allergies to plants or any seasonal allergies Absence of severe pain causes sleep disturbance Obtaining scores of greater than five from the PSQI Sleep quality questionnaire Having an ejection fraction above 45% Being able to read and write Access to social media no limit no limit Both Acute pain at the time of completing the questionnaire Any case that causes olfactory disorders during study Showing an allergic reaction to the smell of essential oils Showing discomfort with the smell of essential oils Occurrence of life-threatening complications such as cardiopulmonary resuscitation I20-I25 Ischaemic heart diseases N/A N/A N/A N/A First intervention group: Aromatherapy with lavender, samples will be exposed to the aromatic substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 4 drops of the relevant aromatic oil (provided by Barijesans Company) on a piece of gauze and attaching it to the patient's collar. This will be done for 30 consecutive days. second intervention group: Aromatherapy with rosemary, samples will be exposed to the aromatic substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 4 drops of the relevant aromatic oil (provided by Barijesans Company) on a piece of gauze attached to the patient's collar. This will be done for 30 consecutive days. The third intervention group: Simultaneous aromatherapy with rosemary and lavender, samples will be exposed to the aromatic substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 2 drops of lavender essential oil and 2 drops of rosemary essential oil (provided by Barijesans Company) on a piece of gauze attached to the patient's collar and this will be done for 30 consecutive days. Control group: Samples will be exposed to the placebo substance three times a day at 8 am, 3 pm and 10 pm for 20 minutes by pouring 4 drops of saline solution on a piece of gauze and attaching it to the patient's collar and this will be done for 30 consecutive days. Depression score in Cardiac Depression Scale (CDS). Timepoint: Before the intervention, 14 and 30 days after the start of the intervention. Method of measurement: Cardiac Depression Scale (CDS). Anxiety score in Hospital Anxiety and Depression Scale (HADS ). Timepoint: Before the intervention, 14 and 30 days after the start of the intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS ). Sleep quality score in Pittsburgh Sleep Quality Index (PSQI). Timepoint: Before the intervention, 14 and 30 days after the start of the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Mazandaran University of Medical Sciences Approved 2023-10-25 Ethics committee of Mazandaran University of Medical Science No.8 Keshavarz Alley, Keshavarz Blvd, Babol Babol Mazandaran Iran (Islamic Republic of)