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The assessment of the jasmine oil aroma effectiveness on sleep quality in patients undergoing hemodialysis.

Protocol summary

Study aim
Determining the effect of jasmine oil on sleep quality of patients undergoing hemodialysis in Sabzevar dialysis centers in 2021
Design
Randomized Clinical trial with control group, with parallel, single -blind, and outcome assessment
Settings and conduct
The location of the project performong will be Vasei Hospital and Kashefi Dialysis Center in Sabzevar. Hemodialysis patients who meet the inclusion criteria are divided into two groups using random allocation: intervention (receiving jasmine aroma) and control (not receiving jasmine aroma) for one month. before and after intervention sleep quality of patients measured and compared by Pittsburgh questionnaire. In this clinical trial, the statistician will be blinded with lack of information about data in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Get a Pittsburgh questionnaire score greater than 5 • At least 18 years old and at most 70 years old • History of at least 6 months of hemodialysis • Perform hemodialysis at least twice a week for at least 3 hours each time • Having full consciousness exclusion criteria: • Significant hearing and speech disorders • Known respiratory problems such as asthma • Existence of olfactory disorder • Known mental illness and drug addiction
Intervention groups
The intervention group is exposed to 5 drops of jasmine oil every night before going to bed for a month with a cotton swab dipped in oil.This oil, which is prepared from the jasmine flower by Ben Marie method with a concentration of 50% by the Gold Company of Nature, contains the active ingredients of linalyl acetate and benzyl acetate.The control group will receive only standard therapeutic interventions during the study.
Main outcome variables
A sleep quality score based on the Pittsburgh Sleep Quality Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210217050396N1
Registration date: 2021-03-27, 1400/01/07
Registration timing: prospective

Last update: 2021-03-27, 1400/01/07
Update count: 0
Registration date
2021-03-27, 1400/01/07
Registrant information
Name
Alemeh Sultani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 6867
Email address
soltania98@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the jasmine oil aroma effectiveness on sleep quality in patients undergoing hemodialysis.
Public title
The assessment of the jasmine oil aroma effectiveness on sleep quality in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Get a Pittsburgh questionnaire score greater than 5 Having a minimum age of 18 and a maximum of 70 years Have a history of at least 6 months of hemodialysis Perform hemodialysis at least twice a week for at least 3 hours each time Having full consciousness
Exclusion criteria:
Significant hearing and speech disorders Known respiratory problems such as asthma Existence of olfactory disorder Known mental illness and drug addiction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available sampling and will be randomly assigned to intervention and control groups using random allocation blocks.R Software will be used to get the blocks. The blocks are made up of 6 English letters (A,B,C,D,E,F). A ,B,C will be considered for the intervention group, and other three letters (D,E,F) will be considered for the control group. The blocks will be randomly selected in blindfolded manner. Each block will determine the order of entry in the intervention and control groups. Assuming choosing the DCAFBE block means from left hand, first, fourth and sixth, respectively, will be located in the control group, and the second, third, and fifth of participants will be located in the intervention group, respectively. Thus, ten blocks will be selected to complete the sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the lack of a placebo and researcher assistant, blinding the participant and the researcher will not be possible. Only the data analyzer is blinded due to lack of knowing the patients and giving data as A and B group to her.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar university of medical sciences
Street address
Vice Chancellor for Research and Technology , University of Medical Sciences , Campus University , above the Memorial of the Unknown Martyrs, Nuclear Martyrs Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.MEDSAB.REC.1399.196

Health conditions studied

1

Description of health condition studied
Patients undergoing hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Sleep quality score on the Pittsburgh questionnaire is less than 5
Timepoint
اندازه گیری کیفیت خواب در ابتدای مطالعه و یکماه پس از شروع استفاده از رایحه روغن یاسمین
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Every night for a month, before going to bed, they are exposed to 5 drops of jasmine oil. This oil, which is prepared from jasmine flowers by the Ben Marie method with a concentration of 50% by the Golden Nature Company, contains the active ingredients linalyl acetate and benzyl acetate. The method of using this oil in the present study is that we ask the patient or his companion to put 5 drops of Yasmin oil in a dropper containing 10 ccs of oil on a cotton ball each night before going to bed. Drop the prepared material and attach it to the collar of the research unit with a pin, and after waking up, remove it and throw it away. The method of use will be explained to the patient or his companion by the researcher in a practical way.
Category
Treatment - Other

2

Description
Control group: Since the aroma of any type of oil to be used as a placebo may affect the sleep quality of the control group units, we prefer not to use a placebo for these people. Therefore, the control group will receive only standard therapeutic interventions during the study. After one month, the sleep scores of the control and intervention groups are determined using the Pittsburgh questionnaire.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Vasei Dialysis Center
Full name of responsible person
Alemeh Soltani
Street address
A large educational and medical hospital , Nuclear Martyrs Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
+98 51 4465 3861
Email
waseehospital@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Hossein Saghi
Street address
Vice Chancellor for Research and Technology , Nuclear Martyrs Boulevard above the Memorial of the Unknown Martyrs , Campus of the University of Medical Sciences ,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Fax
+98 51 4401 8102
Email
vc.Research@medsab.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Alemeh Sultani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 56, Besat Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618643771
Phone
+98 51 4465 6867
Fax
Email
SoltaniA98@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Education , University Campus , Tohid Shahr Boulevard Building , above the Tomb of the Unknown Martyrs ,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Fax
Email
Mostafarad633@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Alemeh Sultani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 56, Besat Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618643771
Phone
+98 51 4465 6867
Fax
Email
SoltaniA98@medsab.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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