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NCT Number: NCT04630470

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

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.

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Key information

Conditions

Hemodialysis Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kayseri, Türkiye, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Effect of Massage Therapy With Lavender Oil on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2020
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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