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The effect of aromatherapy massage on severity of restless legs syndrome in hemodialysis patients

Protocol summary

Study aim
The effect of lavender aromatherapy message on severity of restless legs syndrome in patients undergoing hemodialysis
Design
Two arm parallel group randomised trial with blinded postoperative care
Settings and conduct
Hemodialys ward in Shahid Rahnemoun Hospital in Yazd In test group,samples underwent aromatherapy massage on the extremities for 30 minutes during the second to third hours of dialysis.Lavender oil was used by Barij Essence Pharmaceutical Company. The massage was performed over four weeks and a total of twelve days during hemodialysis. in control group, no intervention was made Sampling was performed using convenience sampling from mothers with restless legs syndrome who had the criteria to enter the study. Samples were divided into experimental and control groups based on Permuted block randomization (with four blocks).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Dialysis-requiring acute renal failure, at least 3 months of hemodialysis,Persian-speaking, having the ability to communicate verbally, having restless legs syndrome, 3 times a week dialysis, having the physical and mental ability, Having a normal neurological and vascular condition, ferritin > 100 ng/mL, transferrin saturation > 20%, no history of asthma, migraines or allergies, no musculoskeletal disorders disabling physical activity, lack of wounds and redness of the limbs, Any allergic reaction to lavender and, no diabetes. exclusion criteria :a history of cancer, lack of a healthy sense of smell, and a refusal to continue attending the study.
Intervention groups
patients suffering from restless legs syndrome underwent aromatherapy massage on the extremities for 30 minutes. No intervention was made for the control group.
Main outcome variables
severity of Restless leg syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140708018395N3
Registration date: 2020-06-22, 1399/04/02
Registration timing: retrospective

Last update: 2020-06-22, 1399/04/02
Update count: 0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Akram Amrollahi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
amrollahi.akram@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2019-12-21, 1398/09/30
Scientific title
The effect of aromatherapy massage on severity of restless legs syndrome in hemodialysis patients
Public title
The effect of oil massage therapy on severity of restless legs syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having restless legs syndrome undertaking dialysis 3 times a week Dialysis-requiring acute renal failure at least 3 months of hemodialysis being Persian-speaking having the ability to communicate verbally having the physical and mental ability Having a normal neurological and vascular condition ferritin > 100 ng/mL transferrin saturation > 20% no history of asthma, migraines or allergies no musculoskeletal disorders disabling physical activity lack of wounds and redness of the limbs Any allergic reaction to lavender and
Exclusion criteria:
suffering from cancer lack of a healthy sense of smell suffering from Diabetis refusal to continue attending the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 41
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed based on the judgmental sampling from patients with restless legs syndrome who had the criteria to enter the study. To unify the sample size, Samples were divided into experimental and control groups based on Permuted block randomization (with two blocks) and to conceal allocation, we used (Numbered drug containers).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
No.2 building,shahid sadoughi aveniue, Bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2014-12-07, 1393/09/16
Ethics committee reference number
187650

Health conditions studied

1

Description of health condition studied
rls
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Rls
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
the severity of restless legs syndrome
Timepoint
before the study and intervention- the last session of the study and intervention
Method of measurement
restless legs syndrome questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:This study is a randomized clinical trial. The population of this study was hemodialysis patients with restless legs syndrome hospitalized in the hemodialysis ward of Shahid Rahnemoun Hospital in Yazd. Sampling was performed by convenience method and randomly assigned into 2 groups.. The research units underwent effleurage massage on the extremities along with lavender oil for 30 minutes during the second to third hours of dialysis,3 times a week by researchers. The amount of oil used for each massage therapy session was 10 cc, and each foot was massaged for 15 minutes. Lavender oil was used by Barij Essence Pharmaceutical Company. The massage was performed over four weeks and a total of twelve days during hemodialysis by colleagues of the same-sex patient who had been trained.
Category
Treatment - Other

2

Description
Control group:No intervention was made for the control group, and they were only asked to move their legs during hemodialysis to relieve symptoms.Samples of the control group of patients undergoing hemodialysis were selected on Saturdays, Mondays, and Wednesdays.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahnemoon Hospital
Full name of responsible person
Akram Amrollahi
Street address
22Bahman Blvd
City
Yazd
Province
Yazd
Postal code
8917644488
Phone
+98 35 3724 1645
Fax
+98 35 3824 1755
Email
amrollahi.akram@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar square, shahid sadoughi aveniue, No.2 building
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
+98 35 3826 1500
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Akram Amrollahi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
22Bahman Blvd
City
Yazd
Province
Yazd
Postal code
8917644488
Phone
+98 35 3724 1645
Fax
+98 35 3824 1755
Email
amrollahi.akram@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Akram Amrollahi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
22Bahman Blvd
City
Yazd
Province
Yazd
Postal code
8917644488
Phone
+98 35 3724 1645
Fax
+98 35 3824 1755
Email
amrollahi.akram@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Akram Amrollahi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
22Bahman Blvd
City
Yazd
Province
Yazd
Postal code
8917644488
Phone
+98 35 3724 1645
Fax
+98 35 3824 1755
Email
amrollahi.akram@ssu.ac.ir

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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