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Comparative study of the effect of lavender, rosemary and orange essential oil on retrospective, prospective memory and drug compliance in hemodialysis patients

Protocol summary

Study aim
Effect of Lavender, Orange and Orange Essences on Retrospective, Prospective, and Pharmaceutical Follow-up in Hemodialysis Patients
Design
Clinical trial with control group, with parallel groups, non-blind, randomized minimization, with sample size 128
Settings and conduct
All patients with hemodialysis who are eligible to study in the dialysis departments of Shafa Hospital and Javad Alaeman, affiliated to Kerman University of Medical Sciences, are the sample of the study. Patients are entered into the study with available sampling method and are divided into four groups in the form of a lottery.
Participants/Inclusion and exclusion criteria
Not having any personality disorder with your doctor's diagnosis Not having chronic respiratory disease History of at least 6 months hemodialysis; If you need to be admitted during the study In case of allergy during the study
Intervention groups
In the control group, only the usual care of the dialysis units and in fact training on adherence to the drug regimen is presented, and only the drug compliance questionnaire, retrospective memory and prospective memory are completed by these individuals. Intervention groups include lavender, rosemary and orange, which will use these essential oils for three months a week. Drug compliance questionnaires, retrospective and prospective memory are completed by these individuals.
Main outcome variables
Effect of lavender essential oil on retrospective, prospective and pharmacological follow-up of hemodialysis patients Effect of rosemary essential oil on retrospective, prospective memory and drug compliance in hemodialysis patients Effect of orange essential oil on retrospective, prospective memory and drug compliance of hemodialysis patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190428043410N1
Registration date: 2019-06-25, 1398/04/04
Registration timing: prospective

Last update: 2019-06-25, 1398/04/04
Update count: 0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
neda dehghan Ahmadabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3377 8760
Email address
n.dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of lavender, rosemary and orange essential oil on retrospective, prospective memory and drug compliance in hemodialysis patients
Public title
The effect of essential oil on memory in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having any personality disorder with your doctor's diagnosis Not having chronic respiratory disease Lack of alcohol or other narcotics Not having history of head trauma or seizure, stroke and brain tumor There is no problem in the sense of smell Not sensitized to plants Not having a disturbance in consciousness History of hemodialysis for at least 6 months Not having a history of dementia, and Alzheimer, Parkinson, Huntington Having physical and mental ability to answer questions
Exclusion criteria:
If you need to be admitted during the study In case of allergy during the study If more than three sessions during a month do not tend to get a healing scent
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Random Minimization
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
National Ethics Committee for Biomedical Research
Street address
Faculty of Nursing and Midwifery, Razi University of Medical Sciences, Beginning of Seven Alavi Gardens
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2019-06-03, 1398/03/13
Ethics committee reference number
IR.KMU.REC.1398.118

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

Primary outcomes

1

Description
The effect of lavender essential oil on memory and drug compliance in patients undergoing hemodialysis
Timepoint
Three times a week for a month
Method of measurement
Demographic and field information questionnaire, Drug Abuse Measurement Questionnaire, and Retrospective and Prospective Memory Measurement Questionnaire

2

Description
Effect of rosemary essential oil on memory and drug compliance in patients undergoing hemodialysis
Timepoint
Three times a week for a month
Method of measurement
Demographic and field information questionnaire, Drug Abuse Measurement Questionnaire, and Retrospective and Prospective Memory Measurement Questionnaire

3

Description
The effect of orange essential oil on memory and drug compliance in patients undergoing hemodialysis
Timepoint
Three times a week for a month
Method of measurement
Demographic and field information questionnaire, Drug Abuse Measurement Questionnaire, and Retrospective and Prospective Memory Measurement Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the control group, only the usual care of the dialysis units and in fact training on adherence to the drug regimen is presented, and only the drug compliance questionnaire, retrospective memory and prospective memory are completed by these individuals.
Category
Treatment - Other

2

Description
Intervention group: Lavender group: In this group, the samples will use lavender essential oil (2%) three times a week for the usual care (they will be manufactured by Kashan Barij Essen). One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of lavender essential oil are poured into a gassus and placed within a distance of ten centimeters from the patient's nose. The lavender gas is put into a small 10cm container and the patient is asked to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.
Category
Treatment - Other

3

Description
Intervention group: Routine group: In this group, the samples will use 100% essential oil (for the production of Barij Essen, Kashan) three times a week, for a period of one month. One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of daily essential oil are placed on a gas and placed at a distance of ten centimeters from the patient's nose. The daily gas is dipped in a small 10cm container and the patient is instructed to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.
Category
Treatment - Other

4

Description
Intervention group: Orange group: In this group, the samples will be used, in addition to receiving regular care, three times a week for orange essential oil (100%) (the construction of the Bariji Essential Oil Factory of Kashan). One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of orange essential oil are placed on a gas and placed within a distance of ten centimeters from the patient's nose. The orange gas is put into a small 10cm container and the patient is instructed to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital - Javad Alaeman Clinic
Full name of responsible person
Neda Dehghan Ahmadabady
Street address
Faculty of Nursing and Midwifery of Razi, Campus of Medical Sciences, Beginning of Seven Alavi Gardens
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3377 8135
Email
Ndeh197@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Campus of Medical Sciences, Beginning of Seven Alavi Gardens
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
Ndeh197@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Neda Dehghan Ahmadabady
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Razi University of Medical Sciences Campus, Alavi Road
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3377 8135
Email
Ndeh197@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Neda Dehghan Ahmadabady
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Razi University of Medical Sciences Campus, Alavi Road
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3377 8135
Email
Ndeh197@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Neda dehghan ahmadabady
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Razi University of Medical Sciences Campus, Alavi Road
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3377 8135
Email
Ndeh197@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data on the main implications is shared
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Data is available to researchers at academic, scientific and industrial institutions
Under which criteria data/document could be used
Data for use in supplementary research, use in treatment and supplementary research
From where data/document is obtainable
Neda Dehghan Ahmadabady Kerman University of Medical Sciences Ndeh197@gmail.com
What processes are involved for a request to access data/document
Send your written request to Ndeh197@gmail.com. Then, the request will be reviewed and the information will be available.
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