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

Study Overview
=================
Brief Summary
-----------------
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.

Official 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

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Behavioral: massage therapy with lavender oil
* Behavioral: massage therapy with baby oil


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: The placebo control group<br>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<br>* 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<br>|
| Experimental: The study group<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis,, restless leg,, lavender oil,, massage,, quality of life