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

NCT04630470 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis

Keywords

Hemodialysis,; restless leg,; lavender oil,; massage,; quality of life

Outcome Measures

Primary Outcomes (2)

• RLS Severity Rating Scale

  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.

  change from baseline score at the end of one month

• Kidney Disease Quality of Life Short Form (KDQOLTM-36)

  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.

  change from baseline score at the end of one month

Study Arms (2)

The placebo control group

PLACEBO COMPARATOR

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).

Behavioral: massage therapy with baby oil

The study group

EXPERIMENTAL

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).

Behavioral: massage therapy with lavender oil

Interventions

massage therapy with lavender oil 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

The study group

massage therapy with baby oil 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 placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

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

Kayseri, Türkiye, 38039, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  PMID: 19414938 RESULT

• 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.

  PMID: 28948161 RESULT

• 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.

  PMID: 29735856 RESULT

• 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.

  PMID: 30925907 RESULT

• 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.

  PMID: 26835466 RESULT

• 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.

  PMID: 28985917 RESULT

• 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.

  PMID: 32379666 RESULT

• 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.

  PMID: 14592341 RESULT

• 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.

  PMID: 25023924 RESULT

• 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.

  PMID: 14592339 RESULT

• 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.

  PMID: 14592342 RESULT

• 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.

  PMID: 17275473 RESULT

• 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.

  PMID: 8628042 RESULT

• 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.

  PMID: 31987569 RESULT

• 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.

  PMID: 31126564 RESULT

• 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.

  PMID: 34779137 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Massage; lavender oil

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• AYSER DÖNER

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistants

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: January 30, 2019
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)