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The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp

Primary Purpose

Muscle Cramps, Aromatherapy, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.
Baby oil
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Cramps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Above 18 years old,
  • Able to answer questions and communicate,
  • Is conscious and does not have a mental problem,
  • Speaks Turkish,
  • No hearing, sight or speech impairment,
  • Having HD treatment for at least six months,
  • Receiving three HD treatment sessions a week,
  • Dialysis with bicarbonate dialysate,
  • Kt / V value> 1.2,
  • Having a constant dry weight for the last month,
  • Experiencing cramps during hemodialysis sessions or at any other time and who scored at least three or more when the severity of cramp pain was evaluated with the Visual Analog Scale (VAS),
  • Patients who are not allergic to the oils used for massage will be included in the study.

Exclusion Criteria:

  • Pregnant and breastfeeding women,
  • Cancer,
  • Diabetic foot,
  • Lower extremity amputation,
  • Having neurological diseases such as epilepsy, parkinson, dementia, Alzheimer,
  • Those with paraplegia,
  • The lower leg is in a size that prevents the application of massage,
  • had surgery in the last three months,
  • Loss of sensation more than 50% due to neuropathy due to various reasons,
  • Open wound in the foot and lower leg, infection, necrosis, fracture / fracture suspected, soft tissue damage, burn,
  • Peripheral vascular disease,
  • Deep vein thrombosis,
  • Receiving treatment to prevent cramping,
  • Having a severe electrolyte (such as potassium, magnesium, calcium) disorder in blood values,
  • Patients using any of the complementary and integrated methods in the last month will not be included in the study.

Sites / Locations

  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention group (Aromatherapy group)

Placebo group

Control group

Arm Description

With a mixture of Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. essential oils, the foot and lower leg will be massaged for three sessions a week for 30 minutes in each session for four weeks.

The foot and lower leg will be massaged with baby oil for four weeks, three sessions a week, 30 minutes in each session.

No application will be made in addition to standard HD treatment.

Outcomes

Primary Outcome Measures

Visual Analog Scala (VAS)
The widespread use of VAS, which has been used in the research of subjective concepts from past years to the present, has been realized after in 1969. This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. The patient marks the severity of the cramp he is experiencing at that moment, and the starting and ending points of the scale as criteria. A VAS value between 1-3 means "mild pain", between 4-6 means "moderate pain", and a value between 7-10 means "severe pain". Participants will mark the scale each time they experience a cramp.

Secondary Outcome Measures

Quality of Life Index Dialysis Version - III
"Quality of Life Index Dialysis Version-3" was developed in 1985 in America. This scale consists of two parts measuring satisfaction from different areas of life and the importance of these areas for the individual, each part contains 34 items. In the satisfaction part of the 6-degree Likert-type scale consisting of 64 items, there are expressions from "very satisfied" to "not satisfied at all", and "very important to very unimportant" in the importance part. The scale has 4 sub-dimensions: health and function, socio-economic, psychological-beliefs, and family. The "translated total score" is obtained by combining the satisfaction and importance scores of the scale with a special formula.

Full Information

First Posted
April 21, 2021
Last Updated
January 7, 2023
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT04874857
Brief Title
The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp
Official Title
The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp on Cramp Frequency, Severity of Pain and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
December 28, 2022 (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
This study is a randomized controlled and single-blind study consisting of qualitative and quantitative stages to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in crampy hemodialysis (HD) patients.
Detailed Description
Data-collecting interviewers are blind to which patients are in which group. The days and sessions of the groups were randomly determined after patients meeting the research criteria of the intervention, placebo control, and control groups were ranked. The population of the study consists of 566 patients treated in institutions that allow the research to be conducted. 145 patients participated in the study and the study was terminated with 94 patients. In the study, aromatherapy massage was applied to the intervention group, baby oil massage was applied to the placebo control group, while no application was made to the control group other than routine care. Aromatherapy massage to the intervention group; It was applied with a mixture of 7% lavender, rosemary and marjoram essential oils. Dependent Variables: Cramp frequency, mean cramp pain severity, and quality of life scale total score. Independent Variables: age, gender, body mass index, marital status, educational status, income level, sociodemographic characteristics such as smoking and alcohol use, characteristics related to the diagnosis-treatment process, concomitant diseases and laboratory parameters. Research data; Intervention and Placebo Group Situation Evaluation Chart, Personal Information Form, Personal Interview Form, Visual Analogue Scale, Quality of Life Index Dialysis Version-III and Control, Intervention and Placebo Group Monitoring Chart were collected. The qualitative data obtained in the study were evaluated using descriptive and content analysis methods. Statistical Package for the Social Sciences program was used to evaluate the quantitative data. A value of p < 0.05 will be accepted as statistical significance criterion. In order to carry out the study, the necessary Academic Committee decision, Ethics Committee approval (dated 11 November 2020 and numbered 13) and institutional permission were obtained. The individuals included in the study were informed about the purpose of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Cramps, Aromatherapy, Hemodialysis, Quality of Life, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (Aromatherapy group)
Arm Type
Experimental
Arm Description
With a mixture of Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. essential oils, the foot and lower leg will be massaged for three sessions a week for 30 minutes in each session for four weeks.
Arm Title
Placebo group
Arm Type
Experimental
Arm Description
The foot and lower leg will be massaged with baby oil for four weeks, three sessions a week, 30 minutes in each session.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No application will be made in addition to standard HD treatment.
Intervention Type
Other
Intervention Name(s)
Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.
Intervention Description
Massage application
Intervention Type
Other
Intervention Name(s)
Baby oil
Intervention Description
Massage application
Primary Outcome Measure Information:
Title
Visual Analog Scala (VAS)
Description
The widespread use of VAS, which has been used in the research of subjective concepts from past years to the present, has been realized after in 1969. This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. The patient marks the severity of the cramp he is experiencing at that moment, and the starting and ending points of the scale as criteria. A VAS value between 1-3 means "mild pain", between 4-6 means "moderate pain", and a value between 7-10 means "severe pain". Participants will mark the scale each time they experience a cramp.
Time Frame
During 1 month
Secondary Outcome Measure Information:
Title
Quality of Life Index Dialysis Version - III
Description
"Quality of Life Index Dialysis Version-3" was developed in 1985 in America. This scale consists of two parts measuring satisfaction from different areas of life and the importance of these areas for the individual, each part contains 34 items. In the satisfaction part of the 6-degree Likert-type scale consisting of 64 items, there are expressions from "very satisfied" to "not satisfied at all", and "very important to very unimportant" in the importance part. The scale has 4 sub-dimensions: health and function, socio-economic, psychological-beliefs, and family. The "translated total score" is obtained by combining the satisfaction and importance scores of the scale with a special formula.
Time Frame
At the first and last meeting in 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Above 18 years old, Able to answer questions and communicate, Is conscious and does not have a mental problem, Speaks Turkish, No hearing, sight or speech impairment, Having HD treatment for at least six months, Receiving three HD treatment sessions a week, Dialysis with bicarbonate dialysate, Kt / V value> 1.2, Having a constant dry weight for the last month, Experiencing cramps during hemodialysis sessions or at any other time and who scored at least three or more when the severity of cramp pain was evaluated with the Visual Analog Scale (VAS), Patients who are not allergic to the oils used for massage will be included in the study. Exclusion Criteria: Pregnant and breastfeeding women, Cancer, Diabetic foot, Lower extremity amputation, Having neurological diseases such as epilepsy, parkinson, dementia, Alzheimer, Those with paraplegia, The lower leg is in a size that prevents the application of massage, had surgery in the last three months, Loss of sensation more than 50% due to neuropathy due to various reasons, Open wound in the foot and lower leg, infection, necrosis, fracture / fracture suspected, soft tissue damage, burn, Peripheral vascular disease, Deep vein thrombosis, Receiving treatment to prevent cramping, Having a severe electrolyte (such as potassium, magnesium, calcium) disorder in blood values, Patients using any of the complementary and integrated methods in the last month will not be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serife Cetin, PhD
Organizational Affiliation
Kayseri University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38260
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp

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