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IRCT20200610047725N1 IRCT 2023-04-18 Yasouj University of Medical Sciences Comparison of the effect of aromatherapy and edible rose essential oil on saliva cortisol level and quality of life of chronic renal failure patients undergoing hemodialysis Comparison of the effect of aromatherapy and edible rose essential oil on saliva cortisol level and quality of life of chronic renal failure patients undergoing hemodialysis 2020-10-03 anticipated 72 Complete https://irct.ir/trial/51312 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants will be selected by purposive sampling from the available population and will be allocated through random block allocation to intervention group No.1 (aromatherapy) and intervention group No.2 (oral intake). In this way, by multiplying the number of studied groups (two groups) by 2, the number of samples of each block was calculated as 4. Then, through factorial calculation, the number of blocks resulting from all arrangement modes of people was calculated as 24 blocks (4! = 4 x3 x2 x1 = 24). Possible arrangement blocks of people will be A (gray dummy) for the intervention group No.1 (aromatherapy) and B (white dummy) for intervention group No.2 (oral intake). Since the number of people in each block is 4 people and the estimated sample size is 72 people, therefore by matching 18 random numbers generated by the Sample Randomizer software, The arrangement of people in the research sample and the allocation of each number from 1 to 72 to each one of the intervention group No. 1 (aromatherapy) and intervention group No. 2 (oral consumption) will be determined. Then the block random allocation list will be compiled. In the following, patients suffering from chronic renal failure under hemodialysis will be referred and qualified research samples will be selected by fully explaining the objectives of the study. Based on the priority of the referral, a code is assigned to each of them, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to one of the groups of intervention number 1 (aromatherapy) and intervention number 2 (oral intake) ) will be allocated. This process will continue until the estimated sample size is completed. 0 (exploratory trials) Patients with chronic renal failure under hemodialysis. Intervention 1: Intervention group number 1 (aroma therapy): When the patient is connected to the dialysis machine, a piece of cloth soaked in 3 drops of rose essence with a concentration of 2% is attached to the patient's neck and the patient will be asked to breathe normally. This work will be done 3 times a day and each time for 5 minutes for 4 weeks. Intervention 2: Intervention group number 2 (oral intake): When the patient is connected to the dialysis machine, 15 drops of rose extract will be poured into some water every 8 hours and given to him/her. Totally, 3 doses of medicine will be given to the patient daily. 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 There is no more information.
public Tahereh Taheri
No. 6, 7th Saadi Alley, Old Terminal, Yasuj, Iran.
Yasuj Iran (Islamic Republic of) 7591974433 +98 74 3322 1350 t60.taheri@gmail.com Yasouj University of Medical Sciences scientific Tahereh Taheri
No. 6, 7th Saadi Alley, Old Terminal, Yasuj, Iran.
Yasuj Iran (Islamic Republic of) 7591974433 +98 74 3322 1350 t60.taheri@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Ability to communicate and answer questions Consent to participate in the study and sign the informed consent form Healthy sense of smell Not having an anxiety disorders Not having a history of using aromatherapy Not having asthma and allergies Not brushing teeth At least three months have passed since hemodialysis Doing dialysis at least 2 to 3 times a week Not taking corticosteroids and immunosuppressants Not having active infection Not having a history of organ transplant rejection Dialysis in the morning shift No history of cancer no limit no limit Both Allergy to Rosa damascene and patient reaction to it Taking anti-anxiety and anti-depressant drugs Performing a kidney transplant during the study Change of dialysis method from hemodialysis to peritoneal dialysis during the intervention Hospitalization in the intensive care unit during the intervention N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Treatment - Drugs Intervention group number 1 (aroma therapy): When the patient is connected to the dialysis machine, a piece of cloth soaked in 3 drops of rose essence with a concentration of 2% is attached to the patient's neck and the patient will be asked to breathe normally. This work will be done 3 times a day and each time for 5 minutes for 4 weeks. Intervention group number 2 (oral intake): When the patient is connected to the dialysis machine, 15 drops of rose extract will be poured into some water every 8 hours and given to him/her. Totally, 3 doses of medicine will be given to the patient daily. Salivary cortisol levels. Timepoint: Salivary cortisol levels at the beginning of the study (before the intervention) and one month later. Method of measurement: By ELISA kits. Quality of life. Timepoint: Quality of life at the beginning of the study (before the intervention) and one month later. Method of measurement: Kidney Disease Quality of Life-Short Form (KDQOL-SF) questionnaire. Yasouj University of Medical Sciences Approved 2020-10-03 Ethics committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Iran. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)