- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630470
Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients
November 18, 2020 updated by: Ayser ERAT, TC Erciyes University
Effect of Massage Therapy With Lavender Oil on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients: A Randomized Controlled Trial
The restless leg syndrome (RLS) is among the most common problems for the individuals undergoing hemodialysis (HD) therapy.
This randomized controlled trial was conducted to determine the effect of the massage, applied with 5% lavender oil for the individuals receiving HD therapy, in the first half of HD session three times a week for four weeks on both legs for 10 minutes in each leg, on severity of RLS and quality of life.
The study was completed with 58 patients including 31 people in the intervention group and 27 people in the placebo control group, in 7 hemodialysis centers located in a city center.
The ethics committee approval, informed consent of the individuals and the institutional permission were obtained.
The data were collected using the patient information form, RLS Severity Rating Scale, Kidney Disease Quality of Life Questionnaire (KDQOLTM-36) and patient follow-up charts.
In accordance with the massage application protocol, those in the intervention group were massaged with lavender oil and those in the placebo group were massaged with baby oil.
Chi-square test, t test, repeated measures one-way analysis of variance, and Pearson correlation analysis tests were used to assess the data.
In the comparisons, the value of p<0.05 was accepted as significant.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Türkiye
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Kayseri, Türkiye, Turkey, 38039
- Department of Internal Nursing, Faculty of Health Science, Erciyes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged ≥18 years
- were not pregnant or did not plan pregnancy
- were diagnosed with RLS by a physician
- had at least mild RLS based on the RLS Severity Rating Scale
- had received HD treatment in the HD units for at least 3 months and three sessions per week
- had continued the dialysis treatment at the same institution
- had not changed the treatment schedule before the massage therapy and throughout the study
- could understand and communicate in Turkish
Exclusion Criteria:
- Patients with an allergy to lavender oil
- had an open wound that would hinder the massage therapy
- had lower leg problems such as neuropathy
- had a neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis
- had a history of other CIT methods applied
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: The placebo control group
Each patient received the massage therapy with baby oil on both lower leg areas for 10 minutes on each leg, for 4 weeks, three times a week, in the first half of the HD session (first 2 hours).
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massage therapy with baby oil-on both lower leg areas, for 10 minutes on each leg, for 4 weeks, three times a week, in the HD sessions
|
Experimental: The study group
Each patient received the massage therapy with lavender oil on both lower legs for 10 minutes on each leg, for 4 weeks, three times a week, in the first half of the HD session (first 2 hours).
|
massage therapy with lavender oil-on both lower leg areas, for 10 minutes on each leg, for 4 weeks, three times a week, in the HD sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RLS Severity Rating Scale
Time Frame: change from baseline score at the end of one month
|
The RLS Severity Rating Scale was developed in 2003 by the International Restless Legs Syndrome Study Group.
The scale was applied in the selection of patients and in the weekly evaluation of RLS severity.
The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS.
The overall score indicated the RLS severity.
A minimum score of 0 and a maximum score of 40 could be obtained.
A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.
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change from baseline score at the end of one month
|
Kidney Disease Quality of Life Short Form (KDQOLTM-36)
Time Frame: change from baseline score at the end of one month
|
This scale is used in determining the quality of life of HD patients and those who have end-stage renal disease (ESRD) stages 1-5.
The Turkish validity and reliability study of the scale was conducted by Yıldırım et al., with a Cronbach's alpha value of 0.84-0.91.
KDQOLTM-36 is a personalized scale that includes general tests supported by multi-question scales targeting specific problems such as symptoms, effects of kidney disease on daily life, burden of the kidney disease, working status, cognitive functions, quality of social relations, sexual functions, and sleep among dialysis patients with kidney disease.
Patients are asked questions based on the past month.
The total and subscale scores were calculated based on the KDQOLTM-36 scoring program.
Each item was scored using Likert's method.
The scores range from 0 to 100, and higher scores indicated better health-related quality of life.
"0" indicated the worst health status, whereas "100" indicated the best health status.
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change from baseline score at the end of one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Al-Jahdali HH, Al-Qadhi WA, Khogeer HA, Al-Hejaili FF, Al-Ghamdi SM, Al Sayyari AA. Restless legs syndrome in patients on dialysis. Saudi J Kidney Dis Transpl. 2009 May;20(3):378-85.
- Giannaki CD, Hadjigavriel M, Lazarou A, Michael A, Damianou L, Atmatzidis E, Stefanidis I, Hadjigeorgiou GM, Sakkas GK, Pantzaris M. Restless legs syndrome is contributing to fatigue and low quality of life levels in hemodialysis patients. World J Nephrol. 2017 Sep 6;6(5):236-242. doi: 10.5527/wjn.v6.i5.236.
- Kutlu R, Selcuk NY, Sayin S, Kal O. Restless legs syndrome and quality of life in chronic hemodialysis patients. Niger J Clin Pract. 2018 May;21(5):573-577. doi: 10.4103/njcp.njcp_84_17.
- Lin XW, Zhang JF, Qiu MY, Ni LY, Yu HL, Kuo SH, Ondo WG, Yu Q, Wu YC. Restless legs syndrome in end stage renal disease patients undergoing hemodialysis. BMC Neurol. 2019 Mar 29;19(1):47. doi: 10.1186/s12883-019-1265-y.
- Hashemi SH, Hajbagheri A, Aghajani M. The Effect of Massage With Lavender Oil on Restless Leg Syndrome in Hemodialysis Patients: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e29617. doi: 10.17795/nmsjournal29617. Epub 2015 Dec 1.
- Muz G, Tasci S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Appl Nurs Res. 2017 Oct;37:28-35. doi: 10.1016/j.apnr.2017.07.004. Epub 2017 Aug 1.
- Cevik B, Tasci S. The effect of acupressure on upper extremity pain and quality of life in patients hemodialysis treatment: A Randomized Controlled Trial. Complement Ther Clin Pract. 2020 May;39:101128. doi: 10.1016/j.ctcp.2020.101128. Epub 2020 Mar 2.
- Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003 Mar;4(2):101-19. doi: 10.1016/s1389-9457(03)00010-8.
- Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
- Hening WA, Allen RP. Restless legs syndrome (RLS): the continuing development of diagnostic standards and severity measures. Sleep Med. 2003 Mar;4(2):95-7. doi: 10.1016/s1389-9457(03)00009-1. No abstract available.
- Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
- Yildirim A, Ogutmen B, Bektas G, Isci E, Mete M, Tolgay HI. Translation, cultural adaptation, initial reliability, and validation of the Kidney Disease and Quality of Life-Short Form (KDQOL-SF 1.3) in Turkey. Transplant Proc. 2007 Jan-Feb;39(1):51-4. doi: 10.1016/j.transproceed.2006.10.196.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Mirbagher Ajorpaz N, Rahemi Z, Aghajani M, Hashemi SH. Effects of glycerin oil and lavender oil massages on hemodialysis patients' restless legs syndrome. J Bodyw Mov Ther. 2020 Jan;24(1):88-92. doi: 10.1016/j.jbmt.2019.06.012. Epub 2019 Jun 29.
- Nasiri M, Abbasi M, Khosroabadi ZY, Saghafi H, Hamzeei F, Amiri MH, Yusefi H. Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial. Complement Ther Med. 2019 Jun;44:261-268. doi: 10.1016/j.ctim.2019.05.009. Epub 2019 May 8. Erratum In: Complement Ther Med. 2019 Aug;45:303.
- Doner A, Tasci S. Effect of massage therapy with lavender oil on severity of restless legs syndrome and quality of life in hemodialysis patients. J Nurs Scholarsh. 2022 May;54(3):304-314. doi: 10.1111/jnu.12738. Epub 2021 Nov 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2019
Primary Completion (Actual)
May 6, 2019
Study Completion (Actual)
May 6, 2019
Study Registration Dates
First Submitted
November 10, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
November 20, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Interventional (Oncolys BioPharma Inc)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There are no plans.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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