Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

Effect of Massage Therapy With Lavender Oil on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630470
• Other study ID #: Interventional
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: November 2020
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The restless leg syndrome (RLS) is among the most common problems for the individuals undergoing hemodialysis (HD) therapy. This randomized controlled trial was conducted to determine the effect of the massage, applied with 5% lavender oil for the individuals receiving HD therapy, in the first half of HD session three times a week for four weeks on both legs for 10 minutes in each leg, on severity of RLS and quality of life. The study was completed with 58 patients including 31 people in the intervention group and 27 people in the placebo control group, in 7 hemodialysis centers located in a city center. The ethics committee approval, informed consent of the individuals and the institutional permission were obtained. The data were collected using the patient information form, RLS Severity Rating Scale, Kidney Disease Quality of Life Questionnaire (KDQOLTM-36) and patient follow-up charts. In accordance with the massage application protocol, those in the intervention group were massaged with lavender oil and those in the placebo group were massaged with baby oil. Chi-square test, t test, repeated measures one-way analysis of variance, and Pearson correlation analysis tests were used to assess the data. In the comparisons, the value of p<0.05 was accepted as significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged =18 years

• were not pregnant or did not plan pregnancy

• were diagnosed with RLS by a physician

• had at least mild RLS based on the RLS Severity Rating Scale

• had received HD treatment in the HD units for at least 3 months and three sessions per week

• had continued the dialysis treatment at the same institution

• had not changed the treatment schedule before the massage therapy and throughout the study

• could understand and communicate in Turkish

Exclusion Criteria:

• Patients with an allergy to lavender oil

• had an open wound that would hinder the massage therapy

• had lower leg problems such as neuropathy

• had a neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis

• had a history of other CIT methods applied

Related Conditions & MeSH terms

• Hemodialysis
• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Behavioral:
• massage therapy with lavender oil
massage therapy with lavender oil-on both lower leg areas, for 10 minutes on each leg, for 4 weeks, three times a week, in the HD sessions
• massage therapy with baby oil
massage therapy with baby oil-on both lower leg areas, for 10 minutes on each leg, for 4 weeks, three times a week, in the HD sessions

Locations

Country	Name	City	State
Turkey	Department of Internal Nursing, Faculty of Health Science, Erciyes University	Kayseri	Türkiye

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

Al-Jahdali HH, Al-Qadhi WA, Khogeer HA, Al-Hejaili FF, Al-Ghamdi SM, Al Sayyari AA. Restless legs syndrome in patients on dialysis. Saudi J Kidney Dis Transpl. 2009 May;20(3):378-85. — View Citation

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: diagnost — 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 Internat — View Citation

Çevik B, Tasci S. The effect of acupressure on upper extremity pain and quality of life in patients hemodialysis treatment: A Randomized Controlled Trial. Complement Ther Clin Pract. 2020 May;39:101128. doi: 10.1016/j.ctcp.2020.101128. Epub 2020 Mar 2. — View Citation

Giannaki CD, Hadjigavriel M, Lazarou A, Michael A, Damianou L, Atmatzidis E, Stefanidis I, Hadjigeorgiou GM, Sakkas GK, Pantzaris M. Restless legs syndrome is contributing to fatigue and low quality of life levels in hemodialysis patients. World J Nephrol — 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. — View Citation

Kutlu R, Selcuk NY, Sayin S, Kal O. Restless legs syndrome and quality of life in chronic hemodialysis patients. Niger J Clin Pract. 2018 May;21(5):573-577. doi: 10.4103/njcp.njcp_84_17. — View Citation

Lin XW, Zhang JF, Qiu MY, Ni LY, Yu HL, Kuo SH, Ondo WG, Yu Q, Wu YC. Restless legs syndrome in end stage renal disease patients undergoing hemodialysis. BMC Neurol. 2019 Mar 29;19(1):47. doi: 10.1186/s12883-019-1265-y. — View Citation

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

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. — 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( — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation

Yildirim A, Ogutmen B, Bektas G, Isci E, Mete M, Tolgay HI. Translation, cultural adaptation, initial reliability, and validation of the Kidney Disease and Quality of Life-Short Form (KDQOL-SF 1.3) in Turkey. Transplant Proc. 2007 Jan-Feb;39(1):51-4. — 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 by the International Restless Legs Syndrome Study Group. 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 from baseline score at the end of one month
Primary	Kidney Disease Quality of Life Short Form (KDQOLTM-36)	This scale is used in determining the quality of life of HD patients and those who have end-stage renal disease (ESRD) stages 1-5. The Turkish validity and reliability study of the scale was conducted by Yildirim et al., with a Cronbach's alpha value of 0.84-0.91. KDQOLTM-36 is a personalized scale that includes general tests supported by multi-question scales targeting specific problems such as symptoms, effects of kidney disease on daily life, burden of the kidney disease, working status, cognitive functions, quality of social relations, sexual functions, and sleep among dialysis patients with kidney disease. Patients are asked questions based on the past month. The total and subscale scores were calculated based on the KDQOLTM-36 scoring program. Each item was scored using Likert's method. The scores range from 0 to 100, and higher scores indicated better health-related quality of life. "0" indicated the worst health status, whereas "100" indicated the best health status.	change from baseline score at the end of one month

External Links

•   International Restless Legs Syndrome Study Group Rating Scale (IRLS)
•   Kidney Disease Quality of Life Instrument (KDQOL)