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Erciyes University Faculty of Health Sciences

Key facts

Who runs it
TC Erciyes University
Where
Türkiye1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
84 people enrolled
Started
6 Dec 2023
Ended
12 Jun 2024
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Intervention group lavender oil
  • Placebo group sesame oil
Record updated
25 July 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who used other complementary and integrative therapies methods during the study period will be excluded from the study
  • Those who are sensitive and/or have any allergies to the lavender oil to be used,
  • 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
  • Those with respiratory system disorders,
  • Those who have lower leg problems that would prevent them from applying massage to the lower leg area,
  • Pre-implemented,

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Intervention group LavanderTreatment being tested

    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.

    Treatment: Intervention group lavender oil

  • Placebo group sesamePlacebo, for comparison

    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.

    Treatment: Placebo group sesame oil

  • Control groupNo study treatment, for comparison

    Group of individuals receiving HD treatment who do not receive any treatment other than standard treatment

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
25 July 2024