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