Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Undergoing Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Arabic version of the Restless Legs Syndrome Rating Scale
Study Overview
Brief Summary
The goal of this clinical trial is to learn if whether vibration therapy relieves the intensity of Restless legs syndrome (RLS) symptoms and sleep disturbances among patients undergoing hemodialysis. The main question it aims to answer is:
Is there a difference in the levels of legs restless syndrome and sleep disturbances between hemodialysis patients who receive vibration therapy and those who do not receive it?
Researcher will compare the levels of legs restless syndrome and sleep disturbances between hemodialysis patients who receive vibration therapy and those who do not receive it to see if vibration therapy works to relieve the levels of legs restless syndrome and sleep disturbances.
Participants will take vibration therapy applied on the calf muscle for 10 minutes per session, 2 times per week for total one month, during the first hour of each hemodialysis sessions.
Detailed Description
Background Most hemodialysis patients are faced with a variety of complications such as restless leg syndrome and sleep disorders during the course of their disease. Restless legs syndrome (RLS) is one of the most prevalent problems in patients receiving hemodialysis. Studies indicate that the prevalence of this sensorimotor neurological disorder in hemodialysis patients ranges from (6.6%) to (80%), contrasted to (7%) to (24.1%) in the general population. RLS adversely affects outcomes of patients with chronic renal failure receiving long-term hemodialysis, with significant impacts on sleep quality and quality of life, as well as increased mortality after 2.5 years of follow-up.
In terms of sleep, the quality of sleep in hemodialysis patients is often affected by restless legs syndrome. The individual feels very disturbing, deep creeping sensations inside the leg whenever sitting or lying down. These abnormal sensations cause insomnia, daytime sleepiness, shorter sleep duration, and the use of sedatives and hypnotics. Sleep disturbances and deprivation of sleep induced by RLS can impact the sleep quality and emotional well-being of patients undergoing hemodialysis, potentially resulting in depression, anxiety, and increment risk of cardiovascular issues.
Dialysis nurses should manage hemodialysis problems using efficient nonpharmacological techniques. As previously said, RLS significantly effects on both the physical and mental soundness of patients, in addition to disrupting their daily lives. Furthermore, many of the medications used to treat these individuals are mostly eliminated by the kidneys, producing further complications for the patients. These matters underscore the need of employing non-pharmacological approaches to treat restless legs syndrome and sleep disorders.
Importance of study There are approximately 3,730,000 patients with Chronic kidney Disease (CKD) globally, and the annual growth rate of the disease is 5-6%. According to data, more than 2.5 million patients with end-stage kidney disease are currently undergoing renal replacement therapy (RRT), and this figure is expected to rise to around 4.5 million by 2030. For patients with CKD, the most prevalent technique of RRT is hemodialysis.
Patients with kidney failure receiving continuous hemodialysis experience a variety of symptoms, including restless leg syndrome (RLS) and sleep disturbances. RLS is a clinical disorder with a prevalence ranging from 6.6% to 83% among patients receiving hemodialysis. It is characterized by a strong desire to move the legs, and this desire usually take place in the afternoon and evening. The moving desire is accompanied by uncomfortable and frequently painful feelings in the legs. The legs movement can help reduce painful and uncomfortable legs feelings. Above 90% of individuals with RLS have periodic leg movements (PLM) during sleeping. The periodic leg movements (PLMs) are sporadic and cause involuntary foot dorsiflexion, knee flexion, and sometimes thigh flexion, occurring every 20 to 40 seconds. The uncomfortable nighttime sensibility and need to move the legs generate intermittent movements of leg during sleep, which lateness and disrupt sleep, resulting in repeated awakenings, and promoting daytime drowsiness, all of which reduce the quality of life for patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients passing at least three months after first their hemodialysis
- •Patients who are receiving two or more HD sessions a week, to facilitate patient follow-up.
- •Patients who are willing to participate, because the patients' participation is voluntary.
- •Patients who are alert and able to communicate verbally, to make the program applicable and facilitate the data collection.
Exclusion Criteria
- •Emergency hemodialysis patients, to avoid mal-efficient (apply the program in a harmless manner).
- •Intake of drugs for restless leg syndrome and sleep disturbances.
- •Using vibration and massage therapy at home
- •Recent history of deep vein thrombosis or other vascular complications.
- •Patients who are unable to communicate, because the patients' communication is an essential part of data collection.
- •Patients with severe cardiovascular disorders such as unstable angina, recent myocardial infarction or severe heart failure, because the application of the program may increase cardiovascular stress, which may pose a risk to these patients.
Arms & Interventions
Vibration therapy
Experimental group will take vibration therapy applied on the calf muscle for 10 minutes per session, 2 times per week for total one month, during the first hour of each hemodialysis sessions
Intervention: Vibration therapy (Other)
Routine care
Control group will not exposed to the vibration therapy and will take only routine care.
Outcomes
Primary Outcomes
Arabic version of the Restless Legs Syndrome Rating Scale
Time Frame: There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pre-test: At the first day Post-test 1: two weeks later . Post-test 2: four weeks later.
A five-level Likert rating scale will be employed for rating the severity of Legs Restless Syndrome among patients receiving hemodialysis, ranging from (0 to 4) where (0) representing no RLS, (1) representing mild RLS, (2) representing moderate RLS, (3) representing severe RLS, and (4) represents very severe RLS. The scale consists of 10 items, and the maximum total score for the patient's answers is (40), higher scores indicate more severe symptoms. The severity of RLS is scored as (0) for no RLS, (1 - 10) for mild RLS, (11 - 20) for moderate RLS, (21 - 30) for severe RLS, and (31 - 40) for very severe RLS.
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Time Frame: There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pre-test: At the first day Post-test 1: two weeks later . Post-test 2: four weeks later.
Brief Pittsburgh Sleep Quality Index (B-PSQI) is a self-reported measure with six components. The items are classified and evaluated in five categories: sleep quality, nocturnal awakenings, sleep efficiency, sleep duration, and sleep latency. Each sleep component is coded using a Likert scale ranging from 0 to 3. The sum of the five components gives a total score between 0 and 15, with higher values indicating poorer sleep quality. Scores from 0 to 5 indicate acceptable sleep quality, whereas scores of 6 or higher indicate poor sleep quality.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amjed Abdulabbas Shraida
Lecturer
Kufa University