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

TC Erciyes University

Status: Completed

Conditions: Hemodialysis

Treatments: Behavioral: massage therapy with lavender oil; Behavioral: massage therapy with baby oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04630470

Interventional (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups, including a placebo group

The placebo control group

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: massage therapy with baby oil

The study group

Experimental group

Description:

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).

Treatment:

Behavioral: massage therapy with lavender oil