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Completed

NCT Number: NCT06156930

Erciyes University Faculty of Health Sciences

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.

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Key information

Conditions

Hemodialysis Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, Türkiye, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group lavender oil

Other

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.

Other names: Lavender oil aromatherapy massage

Placebo group sesame oil

Other

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.

Other names: Sesame oil massage

Primary outcomes

  1. RLS Severity Rating Scale

    Time frame: Change compared to the initial score 1 month after aromatherapy massage application

    The 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.

  2. Epworth Sleepiness Scale

    Time frame: Change compared to the initial score 1 month after aromatherapy massage application

    Daytime 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 outcomes

  1. Pittsburg Sleep Quality Index (PSQI)

    Time frame: Change compared to the initial score 1 month after aromatherapy massage application

    PSQI 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'.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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