Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2023-12-06
2024-06-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sleep Quality and Related Factors in Hemodialysis Patients
NCT01327560
Nature-Based Sound Application For Hemodialysis Patients
NCT06165211
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
NCT05787080
The Application of Art Therapy to Patients Undergoing Hemodialysis Treatment
NCT07005960
Recovery Time and Affecting Factors in Hemodialysis Patients
NCT04274556
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group Lavander
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.
Intervention group lavender oil
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.
Placebo group sesame
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.
Placebo group sesame oil
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.
Control group
Group of individuals receiving HD treatment who do not receive any treatment other than standard treatment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention group lavender oil
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.
Placebo group sesame oil
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Scientific and Technological Research Council of Turkey
OTHER
TC Erciyes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ayser DÖNER
Research assistant (Principal Investigator)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AYSER DÖNER
Role: PRINCIPAL_INVESTIGATOR
TC Erciyes University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erciyes University
Kayseri, Türkiye, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Ghasemi M, Rejeh N, Bahrami T, Heravi-Karimooi M, Tadrisi SD, Vaismoradi M. Aromatherapy Massage vs. Foot Reflexology on the Severity of Restless Legs Syndrome in Female Patients Undergoing Hemodialysis. Geriatrics (Basel). 2021 Oct 11;6(4):99. doi: 10.3390/geriatrics6040099.
Hashemi SH, Hajbagheri A, Aghajani M. The Effect of Massage With Lavender Oil on Restless Leg Syndrome in Hemodialysis Patients: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e29617. doi: 10.17795/nmsjournal29617. Epub 2015 Dec 1.
Malekshahi, F., Aryamanesh, F., Fallahi, S. 2018.
Mirbagher Ajorpaz N, Rahemi Z, Aghajani M, Hashemi SH. Effects of glycerin oil and lavender oil massages on hemodialysis patients' restless legs syndrome. J Bodyw Mov Ther. 2020 Jan;24(1):88-92. doi: 10.1016/j.jbmt.2019.06.012. Epub 2019 Jun 29.
Mohammadpourhodki R, Sadeghnezhad H, Ebrahimi H, Basirinezhad MH, Maleki M, Bossola M. The Effect of Aromatherapy Massage With Lavender and Citrus Aurantium Essential Oil on Quality of Life of Patients on Chronic Hemodialysis: A Parallel Randomized Clinical Trial Study. J Pain Symptom Manage. 2021 Mar;61(3):456-463.e1. doi: 10.1016/j.jpainsymman.2020.08.032. Epub 2020 Sep 1.
Muz G, Tasci S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Appl Nurs Res. 2017 Oct;37:28-35. doi: 10.1016/j.apnr.2017.07.004. Epub 2017 Aug 1.
Nasiri M, Abbasi M, Khosroabadi ZY, Saghafi H, Hamzeei F, Amiri MH, Yusefi H. Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial. Complement Ther Med. 2019 Jun;44:261-268. doi: 10.1016/j.ctim.2019.05.009. Epub 2019 May 8.
Oshvandi K, Mirzajani Letomi F, Soltanian AR, Shamsizadeh M. The effects of foot massage on hemodialysis patients' sleep quality and restless leg syndrome: a comparison of lavender and sweet orange essential oil topical application. J Complement Integr Med. 2021 Apr 12;18(4):843-850. doi: 10.1515/jcim-2020-0121.
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003 Mar;4(2):101-19. doi: 10.1016/s1389-9457(03)00010-8.
Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Hening WA, Allen RP. Restless legs syndrome (RLS): the continuing development of diagnostic standards and severity measures. Sleep Med. 2003 Mar;4(2):95-7. doi: 10.1016/s1389-9457(03)00009-1. No abstract available.
Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Erciyes University Health
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.