Evaluation of the Effects of Virtual Reality Glasses and Respiratory Exercises on Symptoms and Quality of Life Among Patients Receiving Hemodialysis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Dialysis Symptom Index (DSI)
研究概览
简要总结
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.
详细描述
Purpose: This study was planned to examine the effects of virtual reality glasses and breathing exercise applications on symptoms and quality of life in patients receiving hemodialysis treatment.
Design: This randomized controlled cross-sectional study will be applied to individuals diagnosed with End-Stage Renal Disease (ESRD) who were treated in hemodialysis units of 3 state hospitals and 2 private hospitals. No randomized controlled study was found using scales on patients diagnosed with ESRD in the literature review. Power analysis was performed using the G*Power (v3.1.7) program to determine the sample size. It was decided that there should be 53 people in the groups for 80% power at α=0.05 level.
People over the age of 18, diagnosed with end-stage renal disease, on hemodialysis for the last 3 months, without communication barriers and volunteering to participate in the study will be included in the study according to the randomization table.
The data will be filled with a questionnaire form containing demographic data, the Dialysis Symptom Index (DSI) and the World Health Organization Quality of Life Scale Short Form Turkish Version (WHOQOL-Bref-TR). Necessary permissions have been obtained from the people who developed the scales.
Patients who meet the research criteria will be assigned to experiment 1 (virtual reality glasses), experiment 2 (breathing exercise) and control groups according to the randomization table. Then;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years old,
- •Being diagnosed with ESRD,
- •Being on hemodialysis for at least 3 months,
- •Not having any sensory loss related to vision or hearing,
- •Not having a psychiatric disease,
- •Being open to communication and cooperation,
- •Being willing to participate in the research
排除标准
- •Being under 18 years of age,
- •Not being in the end stage of chronic kidney disease,
- •Receiving hemodialysis treatment for less than 3 months,
- •Having sensory loss related to vision and hearing,
- •Having a psychiatric disease,
- •Not being open to communication and cooperation,
- •Not volunteering to participate in the research
研究组 & 干预措施
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.
干预措施: routine hemodialysis (Behavioral)
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.
干预措施: routine hemodialysis (Behavioral)
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.
干预措施: Breathing Exercise (Behavioral)
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.
干预措施: routine hemodialysis (Behavioral)
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.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Dialysis Symptom Index (DSI)
时间窗: This form was completed by each patient three times in total, at one-week intervals
It was developed by Hemodialysis patients in order to determine the symptoms experienced by Hemodialysis patients and the level of impact on the patient. The scale, developed from the Memorial Symptom Diagnosis Scale Short Form, consists of 30 items. Responses are obtained on a 5-point Likert scale. The total scale score is obtained by adding up the scores obtained. This value varies between "0-15 0". The value "0" indicates that there is no symptom. The increase in the total points given to the answers towards 150 points shows that the effect of the mentioned symptom is increasing. The internal consistency coefficient of the scale was determined as 0.84.
次要结局
- World Health Organization Quality of Life - Bref(This form was completed by each patient three times in total, at one-week intervals)
研究者
Ecehan Bulut
PhD student
Trakya University