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IRCT20160704028781N3 IRCT 2018-04-28 Iran University of Medical Sciences Comparative study of the effect of aromatherapy with lavender and Benson relaxation technique on anxiety in patients with acute coronary syndrome Comparative study of the effect of aromatherapy with lavender and Benson relaxation technique on anxiety in patients with acute coronary syndrome 2018-05-22 anticipated 96 Complete https://irct.ir/trial/30619 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of allocating samples to the groups will be in a random senary blocked without permutation (16 senary blocks from 96) of each center. In this sampling method, different modes of the three groups using the random numbers table are written on six cards, each card will be placed in an envelopes. These envelopes are placed in a box and the researcher does not know which groups of research will be selected before choosing the card. The statistician (unaware of the study and the groups) identifies with the removal of one of the envelopes from the box, which of the three patients included in the study will fall into the groups, respectively. The process continues to remove all 6 cards from the box, and again the cards are returned to the box, and this random selection is repeated to provide the desired sample size. N/A Acute coronary syndrome. Intervention 1: Intervention group 1:Aromatherapy with lavender:Our point is an aroma of lavender extract in the form of an inhaler, in which people will be asked to smear two drops of 2% lavender smeared on 10-10 cm of gas and inhale it for at least 5 cm distance from the nose for 20 minutes.Patients will do this action Once a day, between 18:00 and 18:00 for two consecutive days. Intervention 2: Intervention group 2: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed once a day between the hours (18-20) for two consecutive days by patients and supervised by the researcher. Intervention 3: Control group: Patients in the control group receive regular care. They are asked to stay on their bed for 20 minutes. Then, the Spielberger Anxiety Inventory will be completed. Yes - There is a plan to make this available What will be shared: General data such as demographic variables and outcomes under study will be published. When: Get started 6 months after printing results To whom: All researchers working in academic and scientific institutions who want the results of the study will be allowed to receive the data. Conditions: Data can be used to enhance science and use results in research. Where to obtain: School of Nursing & Midwifery, Rashid Yasemi St, Vali Asr St,Tehran 00982143651000 nsahraea@gmail.com How to obtain: Once requested, the data will be delivered electronically or in person within one week. Comments:
public Samaneh Sahraei
School of Nursing & Midwifery, Shahid Rashid Yasemi Street, Valiasr Street, Tehran
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 8888 2886 nsahraea@gmail.com Iran University of Medical Sciences scientific Tahereh Najafi Ghezeljeh
School of Nursing & Midwifery, Shahid Rashid Yasemi St, Vali Asr St,Tehran
Tehran Iran (Islamic Republic of) 1۹۹۶۷۱۳۸۸۳ +98 21 4365 1000 nsahraea@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of acute coronary syndrome by a cardiologist 24-48 hours from the time they began to be hospitalized Understanding and speaking in Farsi to provide contact with the patient 18 years of age or older No history of allergies, Eczema and allergy to herbal medicines and essential oils according to the patient's self-report No olfactory defects and respiratory illnesses, such as asthma according to patient's self-report Failure to have known psychiatric or anxiety disorders according to self-report and examination of the patient's file Failure to perform Surgical or therapeutic interventions such as angiography on the day of intervention No hearing problems according to patient's self-report not having muscle paralysis according to patient's self-report non-addiction to drugs and alcohol according to patient's self-report expressing patient from having anxiety 18 years no limit Both Patient's death Any symptoms of allergy, pain, shortness of breath or disorientation during the intervention Transferring the patient from the cardiac care unit to another section I25.1 Atherosclerotic heart disease of native coronary artery Rehabilitation Rehabilitation N/A Intervention group 1:Aromatherapy with lavender:Our point is an aroma of lavender extract in the form of an inhaler, in which people will be asked to smear two drops of 2% lavender smeared on 10-10 cm of gas and inhale it for at least 5 cm distance from the nose for 20 minutes.Patients will do this action Once a day, between 18:00 and 18:00 for two consecutive days. Intervention group 2: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed once a day between the hours (18-20) for two consecutive days by patients and supervised by the researcher. Control group: Patients in the control group receive regular care. They are asked to stay on their bed for 20 minutes. Then, the Spielberger Anxiety Inventory will be completed. Anxiety: Anxiety is an unpleasant mental sensation, discomfort and tension. The meaning of anxiety in this study is a score that patients receive from the Spielberger questionnaire. Timepoint: The Spielberger anxiety inventory questionnaire will be completed before and immediately after each intervention by the researcher's assistance and by interviewing the participant samples. Method of measurement: The Spielberger anxiety inventory questionnaire. Iran University of Medical Sciences Approved 2018-03-27 Ethics Committee of Iran Medical Sciences University of Medical Sciences Iran University of Medical Sciences. Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)