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IRCT20191021045178N3 IRCT 2021-04-27 Shiraz University of Medical Sciences Evaluation of the effect of lemon balm on anxiety and symptom burden of patients undergoing hemodialysis The Effect of Inhalation of Melissa officinalis essence on symptom burden and Anxiety of Patients under Hemodialysis 2020-12-21 anticipated 68 Complete https://irct.ir/trial/52836 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization: First, the researcher selects the samples randomly based on the list in the section based on a table of random numbers. Then, patients are selected according to the inclusion criteria and based on the purpose, and due to the fact that patients are referred to the hemodialysis center as couples and individuals, the days of individuals and couples will be determined as days of intervention or control by tossing a coin. Then, by simple random sampling in each group, patients will be placed in the experimental and control groups, Blinding description: To blind the study, participants are given full explanations on how to perform the intervention before the intervention, but participants are unaware of the allocation of study groups. Also, in collecting data and completing questionnaires, the help of a researcher who is not aware of the division of groups will be used. Also, the statistician who analyzes the data will not know about the assignment of groups. N/A Condition 1: Anxiety. Condition 2: Chronic renal failure. Patients undergoing hemodialysis. Intervention 1: Intervention group: Intervention group: In the intervention group, 200 microliters of pure Melissa officinalis essence is poured on a cotton ball and for 20 minutes, at the beginning of hemodialysis, at a distance of 20 cm from the patient's nose by pin to The patient's clothes are attached and we ask the patient to breathe normally during hemodialysis. Intervention 2: Control group: In the control group, 200 microliters of bitter almond oil is poured on a cotton ball and inhaled by patients. The intervention will be performed 3 times a week during hemodialysis (initial 20 minutes of dialysis) for one month. Yes - There is a plan to make this available What will be shared: Obtaining an official letter of introduction from Hazrat Fatemeh School of Midwifery and Nursing in Shiraz and obtaining permission from the officials of Shiraz University of Medical Sciences Obtaining written consent from the samples to participate in the study - Assuring the research units about the confidentiality of the information received - Participate freely and completely voluntarily in the research samples and considering the right to withdraw from the research - Creating a private environment for interviewing the patient and completing a questionnaire Provide the results of the research if desired by the training center where the researcher has sampled. When: After studying and printing the results To whom: The results of the research will be provided to the participants and relevant organizations upon request. Conditions: Obtain permission from the relevant authorities in the faculty, university and hospital. Keeping participants' information confidential Where to obtain: Shiraz. Zand St., Library of Shiraz School of Nursing and Midwifery. Mr. Ghasemi's library manager. Phone: 00987136474254 How to obtain: The request for the results will be sent to the library of Shiraz School of Nursing and Midwifery. It will be provided to them with the coordination done. Comments:
public Nilofar Pasyar
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3647 4254 Npasyar@sums.ac.ir Shiraz University of Medical Sciences scientific Nilofar Pasyar
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3647 4254 Npasyar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 years and older At least 6 months have passed since the start of hemodialysis hemodialysis three times a week to do Able to understand and speak Persian 18 years no limit Both Patients who do not have the desire or ability to collaborate with researchers Patients with acute respiratory problems History of allergies to plants Chronic mental illness Intolerance to essential oils during the intervention Acute pain during the intervention F40 N18.5 Phobic anxiety disorders Chronic kidney disease, stage 5 Treatment - Other Placebo Intervention group: Intervention group: In the intervention group, 200 microliters of pure Melissa officinalis essence is poured on a cotton ball and for 20 minutes, at the beginning of hemodialysis, at a distance of 20 cm from the patient's nose by pin to The patient's clothes are attached and we ask the patient to breathe normally during hemodialysis. Control group: In the control group, 200 microliters of bitter almond oil is poured on a cotton ball and inhaled by patients. The intervention will be performed 3 times a week during hemodialysis (initial 20 minutes of dialysis) for one month. Anxiety. Timepoint: Before the intervention and 30 days after the intervention. Method of measurement: Spielberger state- trait anxiety inventory. Symptom burden. Timepoint: Before the intervention and 30 days after the intervention. Method of measurement: Dialysis Symptoms Index. Shiraz University of Medical Sciences Approved 2020-12-10 Ethics committee of Shiraz University of Medical Sciences Zand St., in front of Phelestine St., the central building of Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)