Clinical trial NCT04874857: 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
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Cramps
Aromatherapy
Hemodialysis
Quality of Life
Pain
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Visual Analog Scala (VAS)
timeFrame: During 1 month
Secondary outcomes:
measure: Quality of Life Index Dialysis Version - III
timeFrame: At the first and last meeting in 1 month
Other outcomes:
Locations:
city: Melikgazi
country: Turkey
facility: Erciyes University
state: Kayseri
Study officials:
affiliation: Kayseri University
name: Serife Cetin, PhD
role: PRINCIPAL_INVESTIGATOR
References: