Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients

NCT ID: NCT04630470

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2019-05-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

massage therapy with baby oil

Intervention Type BEHAVIORAL

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

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).

Group Type EXPERIMENTAL

massage therapy with lavender oil

Intervention Type BEHAVIORAL

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

Interventions

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massage therapy with lavender oil

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

Intervention Type BEHAVIORAL

massage therapy with baby oil

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ayser DÖNER

Research Assistants

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYSER DÖNER

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Department of Internal Nursing, Faculty of Health Science, Erciyes University

Kayseri, Türkiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 19414938 (View on PubMed)

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.

Reference Type RESULT
PMID: 28948161 (View on PubMed)

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.

Reference Type RESULT
PMID: 29735856 (View on PubMed)

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.

Reference Type RESULT
PMID: 30925907 (View on PubMed)

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.

Reference Type RESULT
PMID: 26835466 (View on PubMed)

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.

Reference Type RESULT
PMID: 28985917 (View on PubMed)

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.

Reference Type RESULT
PMID: 32379666 (View on PubMed)

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.

Reference Type RESULT
PMID: 14592341 (View on PubMed)

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.

Reference Type RESULT
PMID: 25023924 (View on PubMed)

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.

Reference Type RESULT
PMID: 14592339 (View on PubMed)

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.

Reference Type RESULT
PMID: 14592342 (View on PubMed)

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.

Reference Type RESULT
PMID: 17275473 (View on PubMed)

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.

Reference Type RESULT
PMID: 8628042 (View on PubMed)

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.

Reference Type RESULT
PMID: 31987569 (View on PubMed)

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.

Reference Type RESULT
PMID: 31126564 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34779137 (View on PubMed)

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id

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