Erciyes University Faculty of Health Sciences

February 25, 2024 updated by: Ayser DÖNER, TC Erciyes University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Türkiye
      • Kayseri, Türkiye, Turkey, 38039
        • Recruiting
        • Erciyes University
        • Contact:
          • Erciyes University
          • Phone Number: 03522076666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Lavender oil aromatherapy massage
Placebo Comparator: 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.
Other: 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 Names:
  • Sesame oil massage
No Intervention: Control group
Group of individuals receiving HD treatment who do not receive any treatment other than standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RLS Severity Rating Scale
Time Frame: Change compared to the initial score 1 month after aromatherapy massage application
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
Epworth Sleepiness Scale
Time Frame: Change compared to the initial score 1 month after aromatherapy massage application
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburg Sleep Quality Index (PSQI)
Time Frame: Change compared to the initial score 1 month after aromatherapy massage application
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Collaborators

TÜBİTAK

Investigators

  • Principal Investigator: AYSER DÖNER, TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 6, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Erciyes University Health

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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