Comparison of Inhalation Aromatherapy with Lavender Scent and Back Surface Stroke Massage on Fatigue and Sleep Quality in Hemodialysis Patients
Design
Case study: Hemodialysis patients - A clinical trial study - available sampling and assignment method to patients randomly andd blocks with block size 6
Settings and conduct
Place: Shahid Beheshti Abadan
How to do: At first, serum urea, creatinine, albumin, and hemoglobin tests of patients' blood are recorded according to the latest test in the case.
In the next step, in the aroma group, the herbal fragrances will be healed for 12 sessions during the night after each hemodialysis session. In this way, two drops of pure lavender essential oil in a dropper are given to the patient and they are told that exactly before bedtime 2 drops of essential oil on a pre-prepared cotton ball, pinched and attached with a pin to his collar And then throws it in the morning.
The second intervention is a superficial impact massage that is performed in the Massage Therapy intervention group in which patients undergo 12 sessions of 10 minutes overnight after 2 hours of onset of hemodialysis at night by a researcher who has been trained and certified. It will be under massage
In the third group, the control group, there is no intervention and patients receive routine daily care.
Participants/Inclusion and exclusion criteria
Patients under hemodialysis for at least 6 months,Aged 18 years and older.
Perform 3 hemodialysis sessions per week and each session 4 hours/patient expire
Intervention groups
Aromatherapy
Massage therapy
Control
Main outcome variables
fatigue; sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181119041702N1
Registration date:2018-12-28, 1397/10/07
Registration timing:registered_while_recruiting
Last update:2018-12-28, 1397/10/07
Update count:0
Registration date
2018-12-28, 1397/10/07
Registrant information
Name
zeinab raiesifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5336 2608
Email address
raiesifar.z@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavender aromatherapy and surface stroke back massage on the level of fatigue and sleep quality of hemodialysis patients
Public title
Comparison of the effect of aromatherapy and surface stroke back massage on the level of fatigue and sleep quality of patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under hemodialysis for at least 6 months
-able to communicate
willingness to participate in the study
aged 18 years-and-up
3 hemodialysis sessions per week and 4 hours each session
non using of other complementary therapies
Lack of sensitivity to aromatherapy
Exclusion criteria:
Age under 18 years
Unwillingness to participate in research
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
- Assignment of intervention randomly and random block method with block size 6
-The unit of randomization of individuals
-Randomization by a statistics specialist using the table of random permutations
- In this study, depending on the nature of the interventions, there is no blinding condition for patients and researchers.
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
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Nursing Blvd -Negin Irvand 25
City
َAbadan
Province
Khouzestan
Postal code
6975116955
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.AJUMS.REC.1397.620
Health conditions studied
1
Description of health condition studied
dialisis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
The quality of sleep in patients with dialysis
Timepoint
Sleep quality measurement before intervention and 1 and 2 months after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
the level of fatigue in dialysis patients
Timepoint
Fatigue measurement before intervention and 11 times during intervention and 1 and 2 months after intervention
Method of measurement
NRS numerical checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aromatherapy group:After each dialysis session, in a dialis unit of two drops, Two drops of lavender is given to the patient in a syringe to take home, and precisely before bed, the essential oil is poured on a cotton and connected to a pocket with a pin, and it blinks in the morning, and at the next session of the dialysibimar, the effect This intervention is measured using relevant questionnaires, and this process continues for up to 12 sessions.
Category
Treatment - Other
2
Description
Intervention group: Massage Therapy Group:In this group, 12 sessions of back stroke massage in the dialysis unit are performed for patients, and then in the next session of dialysis, the effect of this intervention is measured using relevant questionnaires.
Category
Treatment - Other
3
Description
Control group: The control group does not receive any intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadan Shahid Beheshti Hospital
Full name of responsible person
Shahram Baraz
Street address
No.25, Valie Asr Blvd., Abadan Town
City
Abadan
Province
Khouzestan
Postal code
6975116955
Phone
+98 61 5336 2608
Email
raiesifar.z@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Golestan Blvd, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
40
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
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6975116955
Phone
+98 61 5336 2608
Email
shahrambaraz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6975116955
Phone
+98 61 5336 2608
Email
shahrambaraz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Raiesifar
Position
Msc Stusent
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valie Asr Blvd., Abadan Town
City
Abadan
Province
Khouzestan
Postal code
6975116955
Phone
+98 61 5336 2608
Email
raiesifar.z@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
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
Yes - There is 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
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
The data from this research will only be available to researchers working in academia and academia
Under which criteria data/document could be used
The data is indexed on the site and accessible via personal email
From where data/document is obtainable
To site or email, the person who registered the information
What processes are involved for a request to access data/document
Approximately after 6 months from the publication of the article, data is available to the responsible author via the site or email