The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aromatherapy
- Hemodialysis
- Muscle Cramps
- Pain
- Quality of Life
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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 who meet the research criteria assignment of intervention, placebo and control groups, determination of the days and sessions of the groups will be determined and recorded in the digital randomization environment. 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 and Turcosa program (Turcosa Analytics Ltd Co, Turkey, www.turcosa.com.tr) are 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.
Tracking Information
- NCT #
- NCT04874857
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Serife Cetin, PhD TC Erciyes University