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IRCT20210523051370N5 IRCT 2021-12-20 Mazandaran University of Medical Sciences The effect of lavender on dialysis patients The effect of different doses of lavender on the psychological states and physical fatigue in dialysis patients 2021-12-22 anticipated 120 Complete https://irct.ir/trial/57284 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be selected based on systematic random sampling. Since about 140 patients are at the dialysis center every day, and the number of participants in each group is 40, the fixed periodic interval becomes 3 (140/40~3). Therefore, every third of the patients admitted to this center on Saturdays, Mondays, and Wednesdays are recruited into the experimental group, and the next one enters the control group-1. If any of these patients do not meet the inclusion criteria, the next one will be selected. If they do not meet the inclusion criteria, the previous one will be selected. Finally, 80 patients will be allocated to the experimental group and control group-1. Likewise, the number of patients referring to the center is 140 on Sundays, Tuesdays, and Thursdays. Since the number of required participants in the control group-2 is 40, every third patient will be selected, Blinding description: In this study, the assessor will be blinded to treatment allocation. To eliminate the effect of lavender fragrance on the assessor, a few drops of lavender essential oil will be splashed on the internal layer of their face mask. N/A hemodialysis patients. Intervention 1: Experimental group undergo inhalation of Lavender Angustifolia essential oil with herbarium number 1-133 procured from the Barij Essence Pharmaceutical Company (Kashan, Iran) and stored in semi-opaque UV-resistant glass bottles at room temperature. Lavender essential oil is inhaled on dialysis days for 5 weeks. A cotton ball soaked in two drops of lavender essential oil with concentrations of 10% in the first week (3 sessions), 20% in the second week (3 sessions), 30% in the third week (3 sessions), 40% in the fourth week (3 sessions) and 50% in the fifth week (3 sessions) will be attached to the collar at a distance of 10 cm from the patient's nose. Patient will be asked to breathe normally for 20 minutes. All patients will be in a semi-sitting position when inhaling lavender essential oil. Intervention 2: Control group 1: a cotton ball soaked in two drops of sweet almond oil is attached to the patients' collars at a distance of 10 cm from the nose. Intervention 3: Control group 2: a cotton ball soaked in two drops of sweet almond oil is attached to the patients' collars at a distance of 10 cm from the nose. The difference between the two control groups is the hemodialysis days. If these two control groups have outcomes that differ significantly, then this cannot reflect an effect of the treatment. The power of two control groups exceeds the probability of falsely detecting a treatment effect. No - There is not a plan to make this available Justification or reason for not sharing IPD is All data will be kept confidential.
public Dr Seyed Afshin Shorofi
Mazandaran University of Medical Sciences, Sari, Iran
Sari Iran (Islamic Republic of) 4816715793 +98 911 676 6280 arabhoda1364@gmail.com Mazandaran University of Medical Sciences scientific Dr Seyed Afshin Shrofi
Mazandaran University of Medical Sciences, Sari, Iran
Sari Iran (Islamic Republic of) ۴۸۱۶۷۱۵۷۹۳ 098 11 33367342 ashorofi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 18 years and older Willingness to participate in the study Undergoing dialysis three times a week Ability to communicate Absence of mental disorders No experience of any stressful event in the last 6 months (such as the death of a close relative) Not using sedatives No history of hospitalization due to psychological problems No history of drug and alcohol addiction Dialysis treatment for a minimum of 6 months 18 years no limit Both Kidney transplant candidates Pregnancy or decision to become pregnant Breastfeeding History of allergies to essential oils and perfumes Acute respiratory disease Prevention Prevention Prevention Experimental group undergo inhalation of Lavender Angustifolia essential oil with herbarium number 1-133 procured from the Barij Essence Pharmaceutical Company (Kashan, Iran) and stored in semi-opaque UV-resistant glass bottles at room temperature. Lavender essential oil is inhaled on dialysis days for 5 weeks. A cotton ball soaked in two drops of lavender essential oil with concentrations of 10% in the first week (3 sessions), 20% in the second week (3 sessions), 30% in the third week (3 sessions), 40% in the fourth week (3 sessions) and 50% in the fifth week (3 sessions) will be attached to the collar at a distance of 10 cm from the patient's nose. Patient will be asked to breathe normally for 20 minutes. All patients will be in a semi-sitting position when inhaling lavender essential oil. Control group 1: a cotton ball soaked in two drops of sweet almond oil is attached to the patients' collars at a distance of 10 cm from the nose. Control group 2: a cotton ball soaked in two drops of sweet almond oil is attached to the patients' collars at a distance of 10 cm from the nose. The difference between the two control groups is the hemodialysis days. If these two control groups have outcomes that differ significantly, then this cannot reflect an effect of the treatment. The power of two control groups exceeds the probability of falsely detecting a treatment effect. Anxiety and depression. Timepoint: Before the intervention and the end of the first, second, third, fourth and fifth weeks. Method of measurement: The Hospital Anxiety and Depression Scale. Fatigue. Timepoint: Before the intervention and the end of the first, second, third, fourth and fifth weeks. Method of measurement: Fatigue Severity Scale. Wellbeing. Timepoint: Before the intervention and the end of the first, second, third, fourth and fifth weeks. Method of measurement: Visual Analog Scale. Mazandaran University of Medical Sciences Approved 2020-03-25 Bioethics Committee of Mazandaran University of Medical Sciences Vice Chancellor (Research), Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)