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IRCT20190518043618N1 IRCT 2019-05-21 Mashhad University of Medical Sciences Effect of aromatherapy and breathing relaxation on anxiety and vital signs Comparing the effect of aromatherapy with lavender essential oil and respiratory relaxation on vital signs and anxiety before electroconvulsive therapy in patients with depression 2019-07-23 anticipated 90 Complete https://irct.ir/trial/39657 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization will be used. Using the random number table, the desired number of sample is selected. The numbers are printed and are placed inside an envelope. Then, randomly, patients are divided into three intervention, one, two, and control groups, Blinding description: Participants will be unaware of the intervention and control groups. Patients are randomly divided into three groups using the envelope method. In this method, random numbers are printed and placed inside the envelope. The purpose of the study is explained to the patient who met the inclusion criteria. He/she takes a numbered paper from the envelope and then unpacks it. Then, in this way, the specific number for each patient will identify. In the same way, the patient takes a printed letter (A, B, C) randomly to determine the group of patient. Finally, it is randomly determined that each English letter (A-B-C) is related to which group (intervention group one or two or control group). N/A Anxiety. Intervention 1: First intervention group, aromatherapy: A 5×5 pad dipped in two drops of lavender oil will be attached to the patient's cloth. The patient breathes it for 3 to 5 minutes. Intervention 2: Second intervention group, breathing relaxation: For 10 minutes, the patient is asked to slowly inhale and exhale while counting the numbers 2, 3, 4. Intervention 3: Control group: This group does not receive any intervention. An intervention is not routinely provided in the psychiatric department of Avicenna Hospital to reduce anxiety. No - There is not a plan to make this available Justification or reason for not sharing IPD is Disseminating information about patients with mental disorders may endanger their social lives.
public Zahra Emami Moghaddam
Acecinna Ave., Nursing school
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3859 1511 emamiz@mums.ac.ir Mashhad University of Medical Sciences scientific Farideh Delmoradi
Acecinna Ave., Nursing school
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3859 1511 delmoradif2@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient's caretaker must voluntarily sign an informed consent form for participation in the study. The patient should have a known diagnosis of depression. The patient should score higher than 7 from the Beck Anxiety Inventory. The patient should be referred for the first session of electroconvulsive therapy. The patient should have the ability to speak and understand Persian language. 18 years 60 years Both Having any physical illness that leads to cognitive impairment. Having a history of known anxiety disease Use of anxiolytic drugs 24 hours before the intervention Having a history of drug abuse Treatment - Other Treatment - Other Other First intervention group, aromatherapy: A 5×5 pad dipped in two drops of lavender oil will be attached to the patient's cloth. The patient breathes it for 3 to 5 minutes. Second intervention group, breathing relaxation: For 10 minutes, the patient is asked to slowly inhale and exhale while counting the numbers 2, 3, 4. Control group: This group does not receive any intervention. An intervention is not routinely provided in the psychiatric department of Avicenna Hospital to reduce anxiety. The number of patients whose anxiety scores are higher than 7 measured by Beck's anxiety inventory. Timepoint: Anxiety is measured before intervention and then 30 minutes after intervention. Method of measurement: Beck Anxiety Inventory. Respiratory rate. Timepoint: Before intervention and then 30 minutes after intervention. Method of measurement: Counting the patient's respiratory rate for 1 minutes. Blood pressure. Timepoint: Before intervention and then 30 minutes after intervention. Method of measurement: A mercury sphygmomanometer. Heart rate. Timepoint: Before intervention and then 30 minutes after intervention. Method of measurement: Reading HR from pulse oximetry attached to patient's finger. Arterial oxygen saturation (SaO2 %). Timepoint: Before intervention and then 30 minutes after intervention. Method of measurement: Reading SiO2 from pulse oximetry device attached to patient's finger. Mashhad University of Medical Sciences Approved 2019-05-15 Ethics committee of Mashhad University of Medical Sciences Avicenna Ave., School of Nursing & Midwifery, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)