The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp
Study Details
Study Description
Brief Summary
This study was planned as a randomized controlled and single-blind study consisting of qualitative and quantitative stages in order to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in hemodialysis (HD) patients with cramps. The study will start with a total of 48 patients, including 16 patients in each group. The number of patients to be included in the groups will be determined by making an interim evaluation of the obtained data. In the study, aromatherapy massage was applied to the intervention group and baby oil massage was applied to the placebo group, while no application other than routine care would be applied to the control group.
Research data; Intervention and Placebo Group Situation Assessment Chart, Personal Information Form, Personal Interview Form, Visual Analog Scala, Quality of Life Index Dialysis Version-III (Ferrans & Powers) and Control, Intervention and Placebo Group Monitoring Chart will be collected. Qualitative data obtained in the research will be evaluated using descriptive analysis and content analysis methods. Statistical Package for the Social Sciences (SPSS) program is planned to be used in the evaluation of quantitative data. A value of p <0.05 will be considered as the criterion for statistical significance. In order to conduct the study, the necessary Academic Committee decision, Ethics Committee approval (date 11 November 2020 and number 13) and institutional permission were obtained. The individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study was planned as a randomized controlled and single-blind study consisting of qualitative and quantitative stages in order to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in hemodialysis (HD) patients with cramps. The pollsters who collect data will be blinded to which patients are in which group. After enumerating the patients meeting the research criteria of the intervention, placebo and control groups, the days and sessions of the groups will be determined randomly.
566 patients receiving treatment in institutions that allow the study to be carried out constitute the accessible universe of the study. The study will start with a total of 48 patients, including 16 patients in each group. The number of patients to be included in the groups will be determined by making an interim evaluation of the obtained data. In the study, aromatherapy massage was applied to the intervention group and baby oil massage was applied to the placebo group, while no application other than routine care would be applied to the control group. Aromatherapy massage to the intervention group; It will be applied with a 10% mixture of lavender, rosemary and marjoram essential oils.
Dependent Variables: Cramp frequency, average of cramp pain severity with each follow-up average and total score of the quality of life scale.
Independent Variables: age, gender, body mass index, marital status, educational status, income level, socio-demographic characteristics such as smoking and alcohol use, characteristics related to the diagnosis-treatment process, comorbidities and laboratory parameters.
Research data; Intervention and Placebo Group Situation Assessment Chart, Personal Information Form, Personal Interview Form, Visual Analog Scala, Quality of Life Index Dialysis Version-III (Ferrans & Powers) and Control, Intervention and Placebo Group Monitoring Chart will be collected. Qualitative data obtained in the research will be evaluated using descriptive analysis and content analysis methods. Statistical Package for the Social Sciences (SPSS) program is planned to be used in the evaluation of quantitative data. A value of p <0.05 will be considered as the criterion for statistical significance. In order to conduct the study, the necessary Academic Committee decision, Ethics Committee approval (date 11 November 2020 and number 13) and institutional permission were obtained. The individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group (Aromatherapy group) 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. |
Other: Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.
Massage application
|
| Experimental: Placebo group The foot and lower leg will be massaged with baby oil for four weeks, three sessions a week, 30 minutes in each session. |
Other: Baby oil
Massage application
|
| No Intervention: Control group No application will be made in addition to standard HD treatment. |
Outcome Measures
Primary Outcome Measures
- Visual Analog Scala (VAS) [During 1 month]
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 the study of Aitken and Zealley 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 (Ferrans & Powers) [At the first and last meeting in 1 month]
"Quality of Life Index Dialysis Version-3" was developed by Ferrans and Power 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Above 18 years old,
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Able to answer questions and communicate,
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Is conscious and does not have a mental problem,
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Speaks Turkish,
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No hearing, sight or speech impairment,
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Having HD treatment for at least six months,
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Receiving three HD treatment sessions a week,
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Dialysis with bicarbonate dialysate,
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Kt / V value> 1.2,
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Having a constant dry weight for the last month,
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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),
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Patients who are not allergic to the oils used for massage will be included in the study.
Exclusion Criteria:
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Pregnant and breastfeeding women,
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Cancer,
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Diabetic foot,
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Lower extremity amputation,
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Having neurological diseases such as epilepsy, parkinson, dementia, Alzheimer,
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Those with paraplegia,
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The lower leg is in a size that prevents the application of massage,
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had surgery in the last three months,
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Loss of sensation more than 50% due to neuropathy due to various reasons,
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Open wound in the foot and lower leg, infection, necrosis, fracture / fracture suspected, soft tissue damage, burn,
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Peripheral vascular disease,
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Deep vein thrombosis,
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Receiving treatment to prevent cramping,
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Having a severe electrolyte (such as potassium, magnesium, calcium) disorder in blood values,
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Patients using any of the complementary and integrated methods in the last month will not be included in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erciyes University | Melikgazi | Kayseri | Turkey | 38260 |
Sponsors and Collaborators
- TC Erciyes University
Investigators
- Principal Investigator: Serife Cetin, PhD, TC Erciyes University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Erciyes University
- PhD student