Clinical trial NCT04630470: Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Hemodialysis,
restless leg,
lavender oil,
massage,
quality of life
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: RLS Severity Rating Scale
timeFrame: change from baseline score at the end of one month
measure: Kidney Disease Quality of Life Short Form (KDQOLTM-36)
timeFrame: change from baseline score at the end of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Department of Internal Nursing, Faculty of Health Science, Erciyes University
state: Türkiye
Study officials:
References:
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