Clinical trial NCT06968130: Effects of Virtual Reality and Breathing Exercises on Hemodialysis Patients' Symptoms and Quality of Life
Official title: Evaluation of the Effects of Virtual Reality Glasses and Respiratory Exercises on Symptoms and Quality of Life Among Patients Receiving Hemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Diseases
Keywords: Hemodialysis
quality of life
general assessment of symptoms
virtual reality
breathing exercise
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Trakya University Scientific Research Projects Unit
First posted: 2025-05-13
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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;

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dialysis Symptom Index (DSI)
timeFrame: This form was completed by each patient three times in total, at one-week intervals
Secondary outcomes:
measure: World Health Organization Quality of Life - Bref
timeFrame: This form was completed by each patient three times in total, at one-week intervals
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli Eğitim ve Araştırma Hastanesi
state: Merkez
Study officials:
affiliation: PhD student
name: Ecehan Bulut
role: PRINCIPAL_INVESTIGATOR
References: