Clinical trial NCT06156930: Erciyes University Faculty of Health Sciences
Official title: Erciyes University Faculty of Health Sciences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Hemodialysis
Restless leg syndrome
Aromatherapy massage
Sleep quality
Lavender oil
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-12-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three-armed
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: RLS Severity Rating Scale
timeFrame: Change compared to the initial score 1 month after aromatherapy massage application
measure: Epworth Sleepiness Scale
timeFrame: Change compared to the initial score 1 month after aromatherapy massage application
Secondary outcomes:
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Change compared to the initial score 1 month after aromatherapy massage application
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Türkiye
Study officials:
affiliation: TC Erciyes University
name: AYSER DÖNER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doner A, Tasci S. Effect of massage therapy with lavender oil on severity of restless legs syndrome and quality of life in hemodialysis patients. J Nurs Scholarsh. 2022 May;54(3):304-314. doi: 10.1111/jnu.12738. Epub 2021 Nov 14.
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