Erciyes University Faculty of Health Sciences

Hemodialysis Clinical Trial

Official title:

Erciyes University Faculty of Health Sciences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156930
• Other study ID #: Erciyes University Health
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: June 6, 2024

Study information

• Verified date: February 2024
• Source: TC Erciyes University
• Contact: AYSER DÖNER
• Phone: 05052349338
• Email: ayserdoner[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 6, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri	Türkiye

Sponsors (2)

Lead Sponsor	Collaborator
TC Erciyes University	TUBITAK

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Complement Ther Med. 2019 Aug;45:303. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RLS Severity Rating Scale	The RLS Severity Rating Scale was developed in 2003. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.	Change compared to the initial score 1 month after aromatherapy massage application
Primary	Epworth Sleepiness Scale	Daytime sleepiness is determined with the scale developed in 1991. The scale consists of 8 questions in total and a high score from the scale indicates an increased level of daytime sleepiness. With this four-point Likert type scale, each question is rated between 0-3. In the evaluation of the scale; 0-5 points: normal, 6-10 points: normal but increased daytime sleepiness, 11-12 points: increased moderate daytime sleepiness, 13-15 points: increased moderate daytime sleepiness, 16-24 points: increased severe daytime sleepiness It is considered as sleepiness. The minimum score is 0, the maximum score is 24, and a total score of 11 or above indicates excessive daytime sleepiness of individuals.	Change compared to the initial score 1 month after aromatherapy massage application
Secondary	Pittsburg Sleep Quality Index (PSQI)	PSQI is a reliable and valid index that measures sleep quality. The total score in the PSQI, which consists of 24 items and is divided into 7 sections (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorder, use of sleeping pills and daytime dysfunction), varies between 0-21, and the PSQI total score is 5 and below. A score above 5 indicates that the sleep quality is 'good', and a score above 5 indicates that the sleep quality is 'bad'.	Change compared to the initial score 1 month after aromatherapy massage application