Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06968130 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Minor Study First Submitted
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
(from sponsor)
Kidney Diseases
Related terms Kidney Diseases
Enrollment 159 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov