Erciyes University Faculty of Health Sciences

TC Erciyes University

Status: Completed

Conditions: Hemodialysis

Treatments: Other: Intervention group lavender oil; Other: Placebo group sesame oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06156930

Erciyes University Health

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups, including a placebo group

Intervention group Lavander

Experimental group

Description:

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:

Other: Intervention group lavender oil

Placebo group sesame

Placebo Comparator group

Description:

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:

Other: Placebo group sesame oil

Control group

No Intervention group

Description:

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