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

Pain Clinical Trial

Official title:

The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp on Cramp Frequency, Severity of Pain and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874857
• Other study ID #: Erciyes University
• Secondary ID: PhD student
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: December 28, 2022

Study information

• Verified date: January 2023
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aromatherapy
• Hemodialysis
• Muscle Cramp
• Muscle Cramps
• Pain
• Quality of Life
• Spasm

Intervention

Other:
• Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.
Massage application
• Baby oil
Massage application

Locations

Country	Name	City	State
Turkey	Erciyes University	Melikgazi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During 1 month
Secondary	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.	At the first and last meeting in 1 month