Protocol summary

Study aim
Determining and 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.
Design
Clinical trial without control group, with parallel groups, non-blind, randomized groups, 72 patients.
Settings and conduct
The studied population is hemodialysis patients referred to Shahid Beheshti and Shahid Jalil hospitals in Yasouj. After the approval of the research proposal by the Research Ethics Committee of Yasouj University of Medical Sciences, at the beginning of the study, questionnaires of demographic characteristics and short form of kidney disease quality of life will be completed and a saliva sample will be taken early in the morning. One month later, the patient's saliva will be collected again using ELISA kits to measure the salivary cortisol level and the short-form kidney disease quality of life questionnaire will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. At least three months have passed since hemodialysis. 2. Doing dialysis at least 2 to 3 times a week Exclusion criteria: 1. Allergy to Rosa damascene and patient reaction to it 2. Taking anti-anxiety and anti-depressant drugs
Intervention groups
The two intervention groups will be aromatherapy and oral intake. In aroma therapy group, 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 collar 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. In oral intake group when the patient is connected to the dialysis machine, 15 drops of rose extract will be poured into some water and every 8 hours given to him/her (3 doses in day).
Main outcome variables
Salivary cortisol levels and Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200610047725N1
Registration date: 2023-04-18, 1402/01/29
Registration timing: retrospective

Last update: 2023-04-18, 1402/01/29
Update count: 0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Tahereh Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 1350
Email address
t60.taheri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-03, 1399/07/12
Expected recruitment end date
2020-11-02, 1399/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.YUMS.REC.1399.135

Health conditions studied

1

Description of health condition studied
Patients with chronic renal failure under hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
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

2

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Tahereh Taheri
Street address
Shahid Mohammad Montazeri St., Shahid Beheshti Hospital, Yasuj, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
beheshtihospital@yasooj.ir

2

Recruitment center
Name of recruitment center
Martyr Dr. Jalil Hospital
Full name of responsible person
Tahereh Taheri
Street address
Martyr Dr. Jalil Hospital, Qarani Blvd., Yasuj, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7004
Email
t60.taheri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591977833
Phone
+98 74 1333 7251
Fax
+98 74 3333 7230
Email
Oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Tahereh Taheri
Position
M.S student of medical-surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, 7th Saadi Alley, Old Terminal, Yasuj, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591974433
Phone
+98 74 3322 1350
Email
t60.taheri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Tahereh Taheri
Position
M.S student of medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, 7th Saadi Alley, Old Terminal, Yasuj, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591974433
Phone
+98 74 3322 1350
Email
t60.taheri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Tahereh Taheri
Position
M.S student of medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, 7th Saadi Alley, Old Terminal, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591974433
Phone
+98 74 3322 1350
Email
t60.taheri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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