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IRCT20221205056718N1 IRCT 2022-12-25 Ghoum University of Medical Sciences effect of aromatherapy with peppermint essential oil on pain and Hemodynamic parameters in patients with acute coronary syndrome Survey the effect of aromatherapy with peppermint essential oil on pain and Hemodynamic parameters in patients with acute coronary syndrome (ACS) 2022-12-22 anticipated 170 Complete https://irct.ir/trial/67257 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who are eligible for the study are entered into the study using the available method and are randomly assigned to two intervention and control groups using the block method (blocks of four and with an allocation ratio of 1:1 using a random number table). . For example, the first four participants enrolled form the first block and the next four form the next block, and so randomization occurs within blocks, so with blocks of size four there are six possible patterns: AABB, ABAB, ABBA , BAAB, BABA, and BBAA, each block is randomized based on one of these six patterns, and the patterns are chosen randomly and generally independently from block to block. N/A Condition 1: Diseases of the circulatory system. Condition 2: complementary medicine. Condition 3: Pain and hemodynamic symptoms. Condition 4: anxiety. Intervention 1: Intervention group: Peppermint essential oil of Barij company is 0.2 ml of 100% essential oil that they inhale on the eye pads. Mint essential oil and placebo with similar appearance produced by Barij Essan Daru Company are placed in dark bottles with similar sizes and shapes. Aromatherapy for the control group and the intervention group in different places and periods of different uses related to acute stress, treatment, hemodynamic treatments and the intensity of chest pain before aromatherapy (time 1), 5 (time 2) and 15 (time) 3) minutes, 30 minutes after aromatherapy (time 4) after the first stage of aromatherapy, then after 30 minutes (1 hour of aromatherapy) the numbers of the study will be measured (time 5) and the second stage of aromatherapy The patient will be exposed to aromatherapy for 20 minutes. Changes in the study will be recorded at 5 (time 6) and 15 (time 7) and 30 minutes after the second phase of aromatherapy (time 8). Intervention 2: In the control group, the patients will be treated with a non-absorbent eye pad with 0.2 ml of normal saline for 20 minutes, and for the intervention group, the same steps will be performed in another room, but instead of normal saline, the peppermint essential oil of Barij Essance Company will be used. 0.2 ml with a concentration of 100% is used on the pads, and in both groups the desired pads are attached to the clothes of the patients in the chest area by a pin. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The second half of 1402 To whom: There is no restriction on access to the results Conditions: There are no restrictions after de-identifying people Where to obtain: hossein sharafi tell:00989173596990 h_sharafi68@yahoo.com How to obtain: There are no restrictions Comments:
public Hossein Sharafi
Qom University of Medical Sciences ,pardisan
Qom Iran (Islamic Republic of) 3749153434 009892531971087 h_sharafi68@yahoo.com Ghoum University of Medical Sciences scientific Hossein Sharafi
Pardisan,Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3749153434 +98 25 3197 1087 h_sharafi68@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Full consciousness Age range 18-60 years Absence of valvular heart disease Severe disease conditions Any vision, hearing, or smell disorder Absence of respiratory and allergic problems No drug addiction Absence of liver and kidney problems Not taking sedatives 4 hours before the intervention No history of any confirmed mental illness such as depression, anxiety, stress 18 years 60 years Both Sudden occurrence of any severe changes in vital signs and the presence of dangerous cardiac dysrhythmias in patients Unwillingness to continue participating in the study I20.1 F41.9 Angina pectoris with documented spasm Anxiety disorder, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Peppermint essential oil of Barij company is 0.2 ml of 100% essential oil that they inhale on the eye pads. Mint essential oil and placebo with similar appearance produced by Barij Essan Daru Company are placed in dark bottles with similar sizes and shapes. Aromatherapy for the control group and the intervention group in different places and periods of different uses related to acute stress, treatment, hemodynamic treatments and the intensity of chest pain before aromatherapy (time 1), 5 (time 2) and 15 (time) 3) minutes, 30 minutes after aromatherapy (time 4) after the first stage of aromatherapy, then after 30 minutes (1 hour of aromatherapy) the numbers of the study will be measured (time 5) and the second stage of aromatherapy The patient will be exposed to aromatherapy for 20 minutes. Changes in the study will be recorded at 5 (time 6) and 15 (time 7) and 30 minutes after the second phase of aromatherapy (time 8). In the control group, the patients will be treated with a non-absorbent eye pad with 0.2 ml of normal saline for 20 minutes, and for the intervention group, the same steps will be performed in another room, but instead of normal saline, the peppermint essential oil of Barij Essance Company will be used. 0.2 ml with a concentration of 100% is used on the pads, and in both groups the desired pads are attached to the clothes of the patients in the chest area by a pin. Pain related to aromatherapy. Timepoint: Before and immediately after intervention. Method of measurement: Visual Analogue Scale. Anxiety related to aromatherapy. Timepoint: Before and immediately after intervention. Method of measurement: Depression Anxiety and Stress Scale 21 (DASS-21). Hemodynamic parameters. Timepoint: Before and immediately after intervention. Method of measurement: Digital heart monitoring system. Ghoum University of Medical Sciences Approved 2022-11-21 Research Ethics Committee of Qom University of Medical Sciences No. 83, Safashehr St., Shahid Lotfi Niaser- Shahid Lotfi Niaser Alley, Safashehr Street, Qom Qom Ghoum Iran (Islamic Republic of)