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

TC Erciyes University

Status: Completed

Conditions: Hemodialysis; Muscle Cramps; Aromatherapy; Quality of Life; Pain

Treatments: Other: Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.; Other: Baby oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04874857

Erciyes University (Other Identifier)

PhD student (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 3 patient groups

Intervention group (Aromatherapy group)

Experimental group

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.

Treatment:

Other: Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.

Placebo group

Experimental group

Description:

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

Treatment:

Other: Baby oil

Control group

No Intervention group

Description:

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