Effects of Virtual Reality and Breathing Exercises on Hemodialysis Patients' Symptoms and Quality of Life
NCT ID: NCT06968130
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
159 participants
INTERVENTIONAL
2021-08-01
2025-07-28
Brief Summary
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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.
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Detailed Description
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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;
1. Experiment 1 Group 1st Application: After the patients who agree to participate in the study sign the informed consent form, the demographic characteristics of the patients, the DSI and WHOQOL-Bref-TR scales will be filled in by the researcher. The patients will watch a simulation consisting of forest and nature images with virtual reality glasses for a total of 20 minutes before and after hemodialysis.
In the 2nd and 3rd Applications, the patients will watch the same simulation at one-week intervals and then the DSI and WHOQOL-Bref-TR will be filled in.
2. Experiment 2 Group:
The researcher will demonstrate deep breathing exercises in a specific order and have the individuals apply the exercises one-on-one.
Procedure steps:
1. Normal breathing for 1 minute,
2. Chest breathing 20-24 times (approximately 3 minutes),
3. Diaphragmatic breathing (inhale through the nose and exhale through the nose) 20-24 times (approximately 3 minutes),
4. Pursed lip breathing 16-20 times (approximately 2 minutes) (inhale through the nose and exhale through the mouth),
5. Normal breathing for 1 minute
1\. Application: After the patients who agree to participate in the study sign the informed consent form, the demographic characteristics of the patients, DSI and WHOQOL-Bref-TR scales will be filled out by the researcher. The patients will be applied a total of 10 minutes of exercises before and after hemodialysis.
In the 2nd and 3rd applications, the patients will be subjected to the same breathing exercise one week apart and then the DSI and WHOQOL-Bref-TR will be filled in.
3rd Control Group:
1. st Application: After the informed consent form is signed by the patients who agree to participate in the study, the demographic characteristics of the patients, the DSI and WHOQOL-Bref-TR scales will be filled in by the researcher. No procedure will be applied, they will receive routine hemodialysis treatment.
2. nd and 3rd Applications will be performed one week apart and the DSI and WHOQOL-Bref-TR will be filled in after the hemodialysis treatment without any procedure.
Statistics: SPSS Statistical Software program will be used for statistical analyses. While evaluating the study data, descriptive statistical methods (Mean, Standard deviation, median, frequency, ratio) as well as the Shapiro Wilk test and box plot graphics will be used for the normal distribution of the variables.
In the comparison of variables showing normal distribution between groups, 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 evaluated at p\<0.05 level.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
routine hemodialysis
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.
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.
routine hemodialysis
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.
Breathing Exercise
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.
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.
routine hemodialysis
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.
Virtual Reality
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.
Interventions
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routine hemodialysis
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.
Breathing Exercise
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.
Virtual Reality
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Trakya University Scientific Research Projects Unit
UNKNOWN
Trakya University
OTHER
Responsible Party
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Ecehan Bulut
PhD student
Principal Investigators
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Ecehan Bulut
Role: PRINCIPAL_INVESTIGATOR
PhD student
Locations
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Kırklareli Eğitim ve Araştırma Hastanesi
Kırklareli, Merkez, Turkey (Türkiye)
Countries
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Other Identifiers
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TÜTF-BAEK-2021/01
Identifier Type: -
Identifier Source: org_study_id
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