Vibration Massage, Static Stretching Exercise, Intradialytic Muscle Cramps and Stress

Key words: Vibration massage, Static stretching exercise, Intradialytic muscle cramp, Salivary cortisol level, stress. Study design: Randomised controlled trial. Objectives:The aim of this randomised controlled clinical trial was to evaluate the effect of vibration massage and static stretching exercise on intradialytic muscle cramp (severity and duration) and salivary cortisol levels during intradialytic muscle cramp. Phase of the study: For this study, permission was obtained from Eskişehir Osmangazi University Clinical Research Ethics Committee that there was no ethical objection. For the financial support of the study, an application was made to the Scientific and Technological Research Council of Türkiye (TUBITAK), a state institution in Turkey, and the result is awaited. After approval, the data collection phase will begin. Interventional Study Model: Factorial Vibration massage group (Group A), Static stretching exercise (Group B), Control Group (Group C). Masking: Outcomes Assessor. Allocation: Stratified Randomized. Enrollment: The total number of participants to be enrolled in the clinical study was determined as 30. Biospecimen Retention: Collection of saliva for salivary cortisol testing at the time of intradialytic muscle cramp and at 20 minutes after the patients to be included in the study. Target Follow-Up Duration: Participants will be followed up at the time of intradialytic muscle cramp and at the time of its termination. Intervention First intervention group: Vibration massage (Group A). * Initiation of the stopwatch with the onset of intradialytic muscle cramp, * Taking a salivary cortisol test, * 10 minutes of vibration massage, * VAS questioning every 2 minutes during intradialytic muscle cramp, * Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended, * Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp. The second group of intervention: Static stretching exercise (Group B) * Initiation of the stopwatch with the onset of intradialytic muscle cramp, * Taking a salivary cortisol test, * Perform static stretching exercise for 10 minutes, * VAS questioning every 2 minutes during intradialytic muscle cramp, * Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended, * Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp. Control group: Usual care (Group C) * Initiation of the stopwatch with the onset of intradialytic muscle cramp, * Taking a salivary cortisol test, * Usual care, * VAS questioning every 2 minutes during intradialytic muscle cramp, * Stopping the stopwatch as soon as the patient states that the intradialytic muscle cramp has ended, * Repeat salivary cortisol test at 20 minutes from the onset of intradialytic muscle cramp. Outcome Measures Primary Outcome Measure Information: * The effect of vibration massage on the severity, duration and salivary cortisol level of intradialytic muscle cramp. * The effect of static stretching exercise on intradialytic muscle cramp severity, duration and salivary cortisol level. * To determine which intervention (vibration massage and static stretching exercise) is more effective on intradialytic muscle cramp severity, duration and salivary cortisol level. Secondary Outcome Measure: The effectiveness of vibration massage and stretching exercise interventions for acute stress management will be determined. Age Limits: Patients aged 18 years and older. Eligibility Criteria: 18 years of age and over, conscious, Turkish speaking and understanding, accepting the research, With a normal body mass index (18.5-24.9), Patients with intradialytic muscle cramps in the lower limb. Statistical Analysis Plan: The data obtained in the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 programme. The statistician performing the statistics of the data will not be informed which group the patients are in and the interventions applied to the groups, thus statistical blinding will be ensured. Kolmogorov Smirnov Test will be used to determine whether the research data are normally distributed. According to the Kolmogorov Smirnov Test, if p\>0.05, it is determined that the distribution is normal. However, if p\<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are examined. If Skewness and Kurtosis values are between +2 and -2, it is accepted that the variable shows normal distribution. Homogeneity of descriptive characteristics between groups will be tested by chi-square analysis. For the difference between group averages, one-way analysis of variance will be used if the data are normally distributed, and Kruskal Wallis test will be used if the data are not normally distributed. Changes in measurements within the group will be analysed by repeated measures ANOVA test if the data are normally distributed, and by Friedman test if the data are not normally distributed. Informed Consent Form: Informed Voluntary Consent signature will be obtained from patients who agree to participate in the study. The research will be conducted in accordance with the Declaration of Helsinki.