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IRCT20181211041922N1 IRCT 2019-05-27 Mashhad University of Medical Sciences Comparison of the effect of Lavendola Inhalation aroma and Benson relaxation on Anxiety in Patients with Major Depressive Disorder under ECT ECT Comparison of the effect of Lavendola Inhalation aroma and Benson relaxation on Anxiety in Patients with Major Depressive Disorder under ECT 2019-01-21 anticipated 90 Complete https://irct.ir/trial/36058 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: NO, Randomization description: Simple randomization with the help of throwing coins. N/A Major Depressive disorder. Intervention 1: Usual care control group, such as fasting, voiding, and will be carried out jewelry and metals. 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 (6-8) for six consecutive days by patients and supervised by the researcher. Intervention 3: 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 6:00 and 8:00 for six consecutive days. 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 No more information
public Reza Hesari
Abne Sina Street
Mashhad Iran (Islamic Republic of) 9195773391 +98 51 3711 2055 www.HesariR941@mums.ac.ir Mashhad University of Medical Sciences scientific Reza Hesari
Department Of Science and Technology, Mashhad University Of Medical Sciences, Next to the Hoveyze Cinema, University Avenue
Mashhad Iran (Islamic Republic of) 9195773391 +98 51 3859 1511 HesariR941@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) A definitive diagnosis of major depressive disorder is given by the psychiatrist No history of previous ECT Would like to participate in the study The level of upper secondary education is high Speech and voice noproblems Lack of physical illness leads to cognitive impairment Lack of psychotic disorder during ECT Lack of Mental retardation There are no major medical and medical problems involved in the research Anxiety disorder is not severe and not synchronous 20 years 60 years Both Unwillingness of the family or patient to continue to collaborate and participate in research for any reason If sensitized to the lavender extract F32 Major depressive disorder, single episode Other Other Other Usual care control group, such as fasting, voiding, and will be carried out jewelry and metals 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 (6-8) for six consecutive days by patients and supervised by the researcher. 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 6:00 and 8:00 for six consecutive days. Significant anxiety score in patients with major depressive disorder under ECT. Timepoint: The beginning of the study before intervention and after the intervention of the first and the sixth session of shock therapy. Method of measurement: Spielberger Anxiety Inventory. Mashhad University of Medical Sciences Approved 2018-10-04 Ethics committee of Mashhad University of Medical Sciences Crossing Doctora, Street Ibn Sina University School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)