To examine the effect of foot massage with olive oil on the severity of restless legs syndrome in hemodialysis patients
Design
Single blind randomized controlled clinical trial
Settings and conduct
The experimental group will receive foot massage with virgin olive oil and oral paraffin oil will be used for the foot message of the control group. A 10 minutes massage will be performed six times in two weeks. The effusion technique will be used in the massage therapy protocol. Upon completion of the intervention, the International Scale of Restless Legs Syndrome will be completed by both groups.
Primary Outcome Measurements:
Participants/Inclusion and exclusion criteria
• aged ≥18 years
• Willingness to participate in the study
• Loss of consciousness
• Continuous treatment with hemodialysis, three times a week for the last 6 months
• Ability to walk on affected legs independently
• Symptoms of restless legs syndrome at least twice a week
• No any nervous, vascular, and skeletal impairment in the lower limbs
• Allergic to herbal plants
• Any wound, malignancy, fracture and amputation below the knee
• concurrent 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 restless legs syndrome, psychiatric and neurological medications
Intervention groups
Olive oil massage
Main outcome variables
Severity of Restless Legs Syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051370N1
Registration date:2021-07-06, 1400/04/15
Registration timing:prospective
Last update:2021-07-06, 1400/04/15
Update count:3
Registration date
2021-07-06, 1400/04/15
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
2021-07-22, 1400/04/31
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot massage with olive oil on the severity of restless legs syndrome in hemodialysis patients
Public title
The effect of foot massage with olive oil on restless legs syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged ≥18 years ; Willingness to participate in the study; Loss of consciousness (orientation to time, place and person); Continuous treatment with hemodialysis, three times a week for the last 6 months; Ability to walk on affected legs independently; Symptoms of restless legs syndrome at least twice a week; Intact nervous, vascular, and skeletal condition in the lower limbs
Exclusion criteria:
Allergic to herbal plants (including essential oils and herbal extracts); Any wound, malignancy, fracture and amputation below the knee; 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 drug restless legs syndrome medications. Withdrawal criteria: Patient's death; Transportation to other hemodialysis centers; Emergency hemodialysis; Any side effects related to the intervention; Two hemodialysis sessions loss; Missed two dialysis sessions; Interference with 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
Investigator
Outcome assessor
Data analyser
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 randomly assigned to the experimental (group A) and control (group B) groups using block method (17 blocks) of length 4. The blocks will be numbered and sealed in 17 sequentially numbered opaque envelopes in random order (by someone outside the research team and unaware of the research objectives).
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 randomization sequences.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the Assessor, Massage therapists and Statistician will be blind to Randomization.
To eliminate the possible effect of the olive oil odor on the Assessor and Massage therapists, a face mask with a few drops of olive oil on the inside will be used.
Placebo
Used
Assignment
Parallel
Other design features
The experimental group will receive foot massage with virgin olive oil (Loyeh, Iran) and oral paraffin oil (Fadak, Iran) will be used for the foot message of the placebo 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 placebo group, each foot will be massaged using 10 cc 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. Paraffin oil is almost the same in appearance and consistency as olive oil so that it is not possible for the patient and the researcher to distinguish their appearance. Foot massage will be performed by two well-trained nurses (female nurse for female patients and male nurse for male patients). The agreement between the two nurses will be measured by Cohen's Kappa coefficient.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-06-08, 1400/03/18
Ethics committee reference number
IR.MAZUMS.REC.1400.9295
Health conditions studied
1
Description of health condition studied
Restless legs syndrome
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
empty
Intervention groups
1
Description
The experimental group will receive foot massage with virgin olive oil (Loyeh, Iran). 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. Foot massage will be performed by two well-trained nurses (female nurse for female patients and male nurse for male patients). The agreement between the two nurses will be measured by Cohen's Kappa coefficient.
Category
Other
2
Description
The placebo group will receive foot massage with oral paraffin oil (Fadak, Iran). 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 placebo group, each foot will be massaged using 10 cc 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. Paraffin oil is almost the same in appearance and consistency as olive oil so that it is not possible for the patient and the researcher to distinguish their appearance. Foot massage will be performed by two well-trained nurses (female nurse for female patients and male nurse for male patients). The agreement between the two nurses will be measured by Cohen's Kappa coefficient.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj-Abbass Estarabadi Hemodialysis Center
Full name of responsible person
Dr Masoumeh Asgharpour
Street address
Haj-Abbass Estarabadi Hemodialysis Center, Sargord Ghasemi Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 2646
Email
masi9932002@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Prof. Majid Saeedi
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
msaeedi@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
Health Care for Older People; Nursing
Street address
Imam square, Three-way Joibar, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
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 Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Care for Older People; Nursing
Street address
Imam square, Three-way Joibar, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
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
Health Care for Older People; Nursing
Street address
Imam square, Three-way Joibar, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
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