Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients
Primary Purpose
Hemodialysis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage therapy with lavender oil
massage therapy with baby oil
Sponsored by
About this trial
This is an interventional supportive care trial for Hemodialysis focused on measuring Hemodialysis,, restless leg,, lavender oil,, massage,, quality of life
Eligibility Criteria
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
Sites / Locations
- Department of Internal Nursing, Faculty of Health Science, Erciyes University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
The placebo control group
The study group
Arm Description
Each patient received the 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 first half of the HD session (first 2 hours).
Each patient received the massage therapy with lavender oil on both lower legs for 10 minutes on each leg, for 4 weeks, three times a week, in the first half of the HD session (first 2 hours).
Outcomes
Primary Outcome Measures
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.
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 Yıldırım 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04630470
First Posted
November 10, 2020
Last Updated
November 18, 2020
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT04630470
Brief Title
Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
May 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis
Keywords
Hemodialysis,, restless leg,, lavender oil,, massage,, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The placebo control group
Arm Type
Placebo Comparator
Arm Description
Each patient received the 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 first half of the HD session (first 2 hours).
Arm Title
The study group
Arm Type
Experimental
Arm Description
Each patient received the massage therapy with lavender oil on both lower legs for 10 minutes on each leg, for 4 weeks, three times a week, in the first half of the HD session (first 2 hours).
Intervention Type
Behavioral
Intervention Name(s)
massage therapy with lavender oil
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
massage therapy with baby oil
Intervention Description
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
Primary Outcome Measure Information:
Title
RLS Severity Rating Scale
Description
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.
Time Frame
change from baseline score at the end of one month
Title
Kidney Disease Quality of Life Short Form (KDQOLTM-36)
Description
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 Yıldırım 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.
Time Frame
change from baseline score at the end of one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Internal Nursing, Faculty of Health Science, Erciyes University
City
Kayseri
State/Province
Türkiye
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans.
Citations:
PubMed Identifier
19414938
Citation
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Links:
URL
https://eprovide.mapi-trust.org/instruments/international-restless-legs-syndrome-study-group-rating-scale
Description
International Restless Legs Syndrome Study Group Rating Scale (IRLS)
Learn more about this trial
Effect of Massage Therapy on Severity of Restless Legs Syndrome and Quality of Life in Hemodialysis Patients
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