Clinical Trial

Effects of Virtual Reality and Breathing Exercises on Hemodialysis Patients' Symptoms and Quality of Life

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Record status
This record was last updated May 13, 2025 (before its estimated May 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
Purpose: This study aims to examine the effects of virtual reality glasses and breathing exercises on symptoms and quality of life in patients receiving hemodialysis treatment. Design: This randomized controlled cross-sectional study will be conducted in the hemodialysis units of 3 state and 2 private hospitals. Individuals over 18 years old, diagnosed with End-Stage Renal Disease (ESRD), on hemodialysis for at least 3 months, without communication barriers, and volunteering to participate will be included. A power analysis using G\*Power (v3.1.7) determined a sample size of 53 individuals per group for 80% power at α=0.05. Data will be collected through a demographic questionnaire, Dialysis Symptom Index (DSI), and WHOQOL-Bref-TR, with permission obtained from scale developers. Participants will be randomized into three groups: Experiment 1 (Virtual Reality Group): After completing the initial scales, patients will watch a 20-minute nature simulation via virtual reality glasses before and after hemodialysis. This will be repeated in two follow-up sessions one week apart, followed by scale administration. Experiment 2 (Breathing Exercise Group): Patients will perform deep breathing exercises guided by the researcher: 1 minute normal breathing, 3 minutes chest breathing, 3 minutes diaphragmatic breathing, 2 minutes pursed-lip breathing, and 1 minute normal breathing. Exercises will be conducted for 10 minutes before and after hemodialysis, repeated in two follow-up sessions one week apart, with post-session scale completion. Control Group: Patients will receive routine hemodialysis without any additional intervention. The same scales will be administered at baseline and during two follow-ups one week apart. Statistics: Data analysis will be performed using Statistical Package for the Social Sciences (SPSS) Software. Descriptive statistics (mean, standard deviation, median, frequency, ratio) will be used. The Shapiro-Wilk test and box plot graphics will assess normality. For comparisons: ANOVA, Kruskal-Wallis H test, Tukey's post-hoc test, Pearson's chi-square test, Fisher's exact chi-square test, Bonferroni test, and multiple regression model analyses. Significance will be set at p\<0.05.
Trial Details
NCT Number NCT06968130
Lead Sponsor Trakya University
Conditions Kidney Diseases
Enrollment 159 participants
Start Date 2021-08-01
Primary Completion 2025-05-15 (estimated)
Study Completion 2025-07-28 (estimated)
Updated on ClinicalTrials.gov 2025-05-13