Effect of foot massage with lavender essential oil 1.5% in comparison to paraffin oil on the severity of restless legs syndrome and anxiety levels in hemodialysis patients
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Intervention groups
#1
گروه آزمون ماساژ پاها با روغن اسطوخودوس را دریافت خواهند کرد. ماساژ به مدت دو هفته و هر هفته سه بار (مجموعا 6 بار) به مدت 10 دقیقه (هر پا 5 دقیقه) از زیر زانو تا کف هر دو پا انجام خواهد شد. شروع ماساژ یک ساعت پس از شروع دیالیز بیماران خواهد بود. در گروه آزمون هر پا با استفاده از 10 سی سی روغن زیتون از کف پا تا زیر زانو به مدت 5 دقیقه ماساژ داده خواهد شد. ماساژ از سطح پلانتار کف پا به سمت پاشنه و سطح پشتی پا به سمت مچ پا آغاز و سپس قسمت های خلفی و قدامی ساق پا تا زانو ماساژ داده میشود. همین تکنیک بلافاصله برای پای دیگر نیز استفاده خواهد شد. در پروتکل ماساژ درمانی از تکنیک افلوراژ استفاده خواهد شد.
گروه آزمون ماساژ پاها با روغن اسطوخودوس را دریافت خواهند کرد. ماساژ به مدت دو هفته و هر هفته سه بار (مجموعا 6 بار) به مدت 10 دقیقه (هر پا 5 دقیقه) از زیر زانو تا کف هر دو پا انجام خواهد شد. شروع ماساژ یک ساعت پس از شروع دیالیز بیماران خواهد بود. در گروه آزمون هر پا با استفاده از 10 سی سی روغن اسطوخودوس از کف پا تا زیر زانو به مدت 5 دقیقه ماساژ داده خواهد شد. ماساژ از سطح پلانتار کف پا به سمت پاشنه و سطح پشتی پا به سمت مچ پا آغاز و سپس قسمت های خلفی و قدامی ساق پا تا زانو ماساژ داده میشود. همین تکنیک بلافاصله برای پای دیگر نیز استفاده خواهد شد. در پروتکل ماساژ درمانی از تکنیک افلوراژ استفاده خواهد شد.
گروه آزمون ماساژ پاها با روغن اسطوخودوس را دریافت خواهند کرد. ماساژ به مدت دو هفته و هر هفته سه بار (مجموعا 6 بار) به مدت 10 دقیقه (هر پا 5 دقیقه) از زیر زانو تا کف هر دو پا انجام خواهد شد. شروع ماساژ یک ساعت پس از شروع دیالیز بیماران خواهد بود. در گروه آزمون هر پا با استفاده از 10 سی سی روغن زیتوناسطوخودوس از کف پا تا زیر زانو به مدت 5 دقیقه ماساژ داده خواهد شد. ماساژ از سطح پلانتار کف پا به سمت پاشنه و سطح پشتی پا به سمت مچ پا آغاز و سپس قسمت های خلفی و قدامی ساق پا تا زانو ماساژ داده میشود. همین تکنیک بلافاصله برای پای دیگر نیز استفاده خواهد شد. در پروتکل ماساژ درمانی از تکنیک افلوراژ استفاده خواهد شد.
Protocol summary
Study aim
To examine the effect of foot massage with lavender essential oil in comparison to paraffin oil on the severity of RLS and anxiety levels in HD patients
Design
This is a double blind randomized controlled clinical trial. 68 patients will be recruited using convenience sampling method and then will be assigned to the experimental and control groups using permuted block randomisation. The blocks will be numbered and sealed in 17 sequentially numbered opaque envelopes in random order. The envelopes will be opened individually and the patients will be assigned to the groups. The Random Allocation Software 2.0 will be used to generate randomisation sequences.
Settings and conduct
Patients will be recruited from the Shahrvand Dialysis Center (Sari, Iran). The patients, assessor and masseur will be blinded to the random allocation.
A few drops of lavender oil on the assessor's and masseur face mask can suppress the sharpness of the smell of aroma oil. Patients will be wearing a face mask during the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 18-65 years; Willingness to participate in the study; Being conscious; Continuous treatment with HD, three times a week for the last 6 months; Ability to walk on affected legs independently; Having symptoms of RLS at least twice a week
Exclusion criteria: Allergic to herbal plants; Any nervous system, vascular, skeletal and muscular disorders/abnormalities in the lower limbs; participation in other studies investigating the relief of RLS; History of drug/alcohol abuse; Any mental illness, dementia, and intellectual impairment; History of DVT; Pregnancy and breastfeeding; Use of psychiatric, neurological medications and other herbal products
Intervention groups
The EG will receive foot massage with lavender oil.
The CG will receive foot massage with paraffin oil.
Main outcome variables
Severity of RLS; anxiety levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051370N7
Registration date:2022-07-05, 1401/04/14
Registration timing:registered_while_recruiting
Last update:2022-07-17, 1401/04/26
Update count:1
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Seyed Afshin Shorofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ashorofi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-02, 1401/04/11
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot massage with lavender essential oil 1.5% in comparison to paraffin oil on the severity of restless legs syndrome and anxiety levels in hemodialysis patients
Public title
Effect of foot massage with lavender essential oil in comparison to paraffin oil on restless legs syndrome (RLS) and anxiety levels
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18-65 years
Willingness to participate in the study
Being conscious (oriented to place, person and time)
Continuous treatment with hemodialysis (HD), three times a week for the last 6 months
Ability to walk on affected legs independently
Having symptoms of restless legs syndrome at least twice a week
Exclusion criteria:
Allergic to herbal plants (including essential oils and herbal extracts)
Any nervous system, vascular, skeletal and muscular disorders/abnormalities in the lower limbs
Simultaneous participation in other research studies investigating the relief of restless legs syndrome
History of drug and alcohol abuse
Any mental illness, dementia, and intellectual impairment
History of deep vein thrombosis
Pregnancy and breastfeeding
Use of psychiatric and neurological medications
Use of other herbal products to relieve Restless Legs Syndrome
Withdrawal criteria: Patient's death; Transfer to other hemodialysis centers; Emergency hemodialysis; Any side effects related to the intervention; Missing two hemodialysis sessions; Any interaction between the intervention and patients' medical and nursing care; Unwillingness to continue participation; Eligibility criteria violation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited using convenience sampling method and then will be assigned to the experimental group (EG) and control group (CG) groups using permuted block randomisation (17 blocks - block size of 4). The blocks will be numbered and sealed in 17 sequentially numbered opaque envelopes in random order. The envelopes will be opened individually and the patients will be assigned to the relevant groups. The Random Allocation Software 2.0 will be used to generate randomisation sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, assessor and masseur will be blinded to the random allocation.
A few drops of lavender essential oil on the assessor's and masseur face mask can suppress the sharpness of the smell of aroma oil. Patients will also be wearing a face mask during the intervention.
Placebo
Used
Assignment
Parallel
Other design features
The experimental group will receive foot massage with lavender essential oil and oral paraffin oil will be used for the foot message of the control group. A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. In the control group, each foot will be massaged using 10cc of paraffin oil, as in the experimental group, in terms of method and duration. The effleurage technique will be used in the massage therapy protocol.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology, Moalem Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.MAZUMS.REC.1401.171
Health conditions studied
1
Description of health condition studied
Restless legs syndrome; anxiety levels
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Severity of Restless Legs Syndrome
Timepoint
Baseline (before intervention: T0); Follow-ups (after 6th session: T1; a week after the 6th session: T2)
Method of measurement
International Restless Legs Severity Scale
Secondary outcomes
1
Description
Anxiety levels
Timepoint
Baseline (before intervention: T0); Follow-ups (after 6th session: T1; a week after the 6th session: T2)
Method of measurement
HADS-anxiety
Intervention groups
1
Description
The experimental group will receive foot massage with lavender oil. A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. The effleurage technique will be used in the massage therapy protocol.
Category
Prevention
2
Description
The control group will receive foot massage with oral paraffin oil. A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. In the control group, each foot will be massaged using 10cc of paraffin oil, as in the experimental group, in terms of method and duration. The effleurage technique will be used in the massage therapy protocol.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrvand Dialysis Center, Sari, Iran
Full name of responsible person
Dr Seyed Afshin Shorofi
Street address
Shahrvand Dialysis Center, Keshavarz Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3329 1897
Email
ashorofi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice Chancellor for Research and Technology, Moallem Square
City
Sari
Province
Mazandaran
Postal code
48115733971
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary and Integrative Medicine
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 676 6280
Email
ashorofi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shrofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary and Integrative Medicine
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
098 11 33367342
Email
ashorofi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary and Integrative Medicine
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 676 6280
Email
ashorofi@yahoo.com
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