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Erciyes University Faculty of Health Sciences

Erciyes University Faculty of Health Sciences

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06156930
Enrollment
84
Registered
2023-12-05
Start date
2023-12-06
Completion date
2024-06-12
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

Hemodialysis, Restless leg syndrome, Aromatherapy massage, Sleep quality, Lavender oil

Brief summary

Sleep disorders are important to place among the symptoms frequently seen in hemodialysis patients. Among sleep disorders, restless legs syndrome is the most common. Restless legs syndrome, seen in patients receiving hemodialysis treatment, causes excessive daytime sleepiness and negatively affects the sleep quality of individuals.

Interventions

OTHERIntervention group lavender oil

The group will receive aromatherapy massage with a 5% mixture prepared with sesame oil and lavender oil for 10 minutes on both lower leg areas, three times a week for four weeks.

OTHERPlacebo group sesame oil

The group will receive a massage with sesame oil on both lower leg areas for 10 minutes on each leg, three times a week for four weeks.

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double-blind study design

Intervention model description

three-armed

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Those who are 18 years or older, * Not pregnant and not planning a pregnancy, * Having been diagnosed with restless leg syndrome according to the restless leg syndrome diagnostic scale and by a physician, * Having at least mild restless leg syndrome according to the restless leg syndrome severity rating scale, * Scoring 11 or above on the Epworth sleepiness scale, * PSQI score an average of 5 and above, * Receiving hemodialysis treatment in hemodialysis units for at least 3 months and 3 sessions per week, * Continuing dialysis treatment in the same institution, * Able to walk independently, * No changes in the treatment program before the massage and throughout the research process, * Not having any allergies to the oils to be used, * Individuals who can understand and communicate with Turkish will be included in the research

Exclusion criteria

* Those who are sensitive and/or have any allergies to the lavender oil to be used, * Those who have lower leg problems that would prevent them from applying massage to the lower leg area, * Have a history of mental or physical disability, including peripheral neuropathy, vascular problems in the legs, * Epilepsy, Alzheimer's, Parkinson's, Multiple Sclerosis, etc. Those with a diagnosed neurological disease such as * Pre-implemented, * Those with respiratory system disorders, * Patients who used other complementary and integrative therapies methods during the study period will be excluded from the study

Design outcomes

Primary

MeasureTime frameDescription
RLS Severity Rating ScaleChange compared to the initial score 1 month after aromatherapy massage applicationThe RLS Severity Rating Scale was developed in 2003. 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.
Epworth Sleepiness ScaleChange compared to the initial score 1 month after aromatherapy massage applicationDaytime sleepiness is determined with the scale developed in 1991. The scale consists of 8 questions in total and a high score from the scale indicates an increased level of daytime sleepiness. With this four-point Likert type scale, each question is rated between 0-3. In the evaluation of the scale; 0-5 points: normal, 6-10 points: normal but increased daytime sleepiness, 11-12 points: increased moderate daytime sleepiness, 13-15 points: increased moderate daytime sleepiness, 16-24 points: increased severe daytime sleepiness It is considered as sleepiness. The minimum score is 0, the maximum score is 24, and a total score of 11 or above indicates excessive daytime sleepiness of individuals.

Secondary

MeasureTime frameDescription
Pittsburg Sleep Quality Index (PSQI)Change compared to the initial score 1 month after aromatherapy massage applicationPSQI is a reliable and valid index that measures sleep quality. The total score in the PSQI, which consists of 24 items and is divided into 7 sections (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorder, use of sleeping pills and daytime dysfunction), varies between 0-21, and the PSQI total score is 5 and below. A score above 5 indicates that the sleep quality is 'good', and a score above 5 indicates that the sleep quality is 'bad'.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026