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IRCT20210516051316N1 IRCT 2021-09-18 Qazvin University of Medical Sciences The effect of valerian and lavender essential oil on coronary heart disease Evaluation of the effect of aromatherapy with valerian and lavender essential oil on vital signs, drug use and headache relief due to nitroglycerin infusion in coronary artery disease 2021-07-06 anticipated 90 Complete https://irct.ir/trial/56476 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, eligible patients will be divided into three groups: lavender, 2. valerian and 3. control group by random sampling with ball and bag tools. Patients are told that the effect of a scent on them is measured, which is not harmful to them. This process will be performed by one of the ward nurses who is not aware of the research (someone outside the research team). That is, this person numbers the scents and writes the name and number of each scent in an envelope and after completing the analysis to The researcher delivers. Both groups do not know the type of fragrance used and number 1 and 2 are used instead of the name on the fragrance. The researcher and statistical consultant is not aware of this numbering, Blinding description: Both groups did not know the type of fragrance used, and instead of naming the fragrance, numbers 1 and 2 were used by someone outside the research team, and the researcher was not aware of this numbering; Also, the statistical consultant did not know the names of the fragrances and only the analysis was performed with numbers 1 and 2 and the control group. The appearance of the scents and the packaging and the color and shape of their use are quite similar. N/A Coronary artery disease. Intervention 1: Intervention group: 1. Lavender" Patients of the experimental group (lavender group) After complaining of headache, lavender essential oil 1.5% prepared by Kazerun Agro-industrial Company with cotton soaked in 3 drops of it to the collar Inhaled for 30 minutes, vital signs including blood pressure, heart rate, temperature, and blood oxygen saturation before and after the intervention were measured in three groups. The time period (before the intervention and 15, 30 and 60 minutes after the intervention) was measured using the visual pain scale. Intervention 2: Intervention group: 2. Valerian "Patients of the experimental group (Valerian group) After complaining of headache, Valerian essential oil 1.5% prepared by Kazerun Agro-industrial Company with cotton soaked in 3 drops of it to the collar Inhaled for 30 minutes, vital signs including blood pressure, heart rate, temperature, and blood oxygen saturation before and after the intervention were measured in three groups. The time period (before the intervention and 15, 30 and 60 minutes after the intervention) was measured using the visual pain scale. Intervention 3: "Control group" In the control group, no intervention was performed and only the usual methods of pain control performed in the ward were performed in these patients. Vital signs including blood pressure, heart rate, temperature, blood oxygen saturation before and after the intervention were also measured in three groups. The severity of patients' headache in 4 time periods (before the intervention and 15, 30 and 60 minutes after the intervention) was measured using the visual pain scale. 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 After conducting the research, a decision is made
public Leili Yekefallah
Department of Nursing, Social Determinants of Health Research Center, School of Nursing & Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3333 8034 leili_fallah@yahoo.com Qazvin University of Medical Sciences scientific Fatemeh Ghapanvari
Shahid Bahonar Boulevard - Qazvin University of Medical Sciences, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3333 8034 fatemehghapanvari89@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) No previous history of nitrate use no history of allergies no use of painkillers 6 hours before the intervention no headache before the intervention no use of perfume or cologne before or during the intervention No history of drug addiction according to the patient no olfactory disorder according to the patient no limit no limit Both Withdrawal from the study having a headache before the infusion of nitroglycerin decreased level of consciousness during the study allergies caused by the essential oils of valerian and lavender or herbal essences during the study I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Other Treatment - Other Treatment - Other Intervention group: 1. Lavender" Patients of the experimental group (lavender group) After complaining of headache, lavender essential oil 1.5% prepared by Kazerun Agro-industrial Company with cotton soaked in 3 drops of it to the collar Inhaled for 30 minutes, vital signs including blood pressure, heart rate, temperature, and blood oxygen saturation before and after the intervention were measured in three groups. The time period (before the intervention and 15, 30 and 60 minutes after the intervention) was measured using the visual pain scale. Intervention group: 2. Valerian "Patients of the experimental group (Valerian group) After complaining of headache, Valerian essential oil 1.5% prepared by Kazerun Agro-industrial Company with cotton soaked in 3 drops of it to the collar Inhaled for 30 minutes, vital signs including blood pressure, heart rate, temperature, and blood oxygen saturation before and after the intervention were measured in three groups. The time period (before the intervention and 15, 30 and 60 minutes after the intervention) was measured using the visual pain scale. "Control group" In the control group, no intervention was performed and only the usual methods of pain control performed in the ward were performed in these patients. Vital signs including blood pressure, heart rate, temperature, blood oxygen saturation before and after the intervention were also measured in three groups. The severity of patients' headache in 4 time periods (before the intervention and 15, 30 and 60 minutes after the intervention) was measured using the visual pain scale. Blood pressure. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: manometer. Drug use following the inhalation of fragrance and its effect on headache The need for narcotics changes based on the visual pain scale. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: Visual Analogue Scale. Heart rate. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: Heart rate monitoring device. Temperature. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: Mercury thermometer. Respiratory Rate. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: Count the number of breaths per minute based on chest movements while breathing. Percentage of blood oxygen saturation. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: pulse oximetry. Pain. Timepoint: 30 minutes (before the intervention and 15, 30). Method of measurement: Visual Analogue Scale (VAS ). Qazvin University of Medical Sciences Approved 2019-11-21 Research Ethics Committee of Qazvin University of Medical Sciences Shahid Beheshti Boulevard Qazvin Qazvin Iran (Islamic Republic of)