Protocol summary
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Study aim
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To examine the effect of foot massage with olive oil on the severity of restless legs syndrome in hemodialysis patients
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Design
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Double blind randomised controlled clinical trial
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Settings and conduct
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The experimental group will receive foot massage with olive 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 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 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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
• Aged 18-65 years
• Willingness to participate in the study
• Being conscious
• Continuous treatment with hemodialysis, three times a week for the last 6 months
• Ability to walk on affected legs independently
• 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
• Simultaneous participation in other research studies investigating the relief of RLS
• 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 RLS
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Intervention groups
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Olive oil massage
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Main outcome variables
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Severity of Restless Legs Syndrome
General information
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Reason for update
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Foot massage will be performed by a well-trained nurse.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210523051370N1
Registration date:
2021-07-06, 1400/04/15
Registration timing:
prospective
Last update:
2022-07-15, 1401/04/24
Update count:
3
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Registration date
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2021-07-06, 1400/04/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-22, 1400/04/31
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Expected recruitment end date
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2021-09-22, 1400/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of foot massage with olive oil on the severity of restless legs syndrome in hemodialysis patients
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Public title
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The effect of foot massage with olive oil on restless legs syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged 18-65 years;
Willingness to participate in the study;
Being conscious (oriented to place, person and time);
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 (RLS) 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.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be recruited using convenience sampling method and then will be assigned to the experimental and control 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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patients, assessor and masseur will be blinded to the random allocation.
A few drops of olive oil on the assessor's and masseur face mask can suppress the sharpness of the smell of olive oil. Patients will also be wearing a face mask during the intervention.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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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 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 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.
Ethics committees
1
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Ethics committee
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Approval date
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2021-06-08, 1400/03/18
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Ethics committee reference number
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IR.MAZUMS.REC.1400.9295
Health conditions studied
1
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Description of health condition studied
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Restless legs syndrome
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ICD-10 code
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G25.81
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ICD-10 code description
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Restless legs syndrome
Primary outcomes
1
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Description
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Severity of Restless Legs Syndrome
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Timepoint
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Baseline (before intervention: T0); Follow-ups (after 6th session: T1; a week after the 6th session: T2)
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Method of measurement
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International Restless Legs Severity Scale
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable