Kidney DiseasesNCT06968130
Effects of Virtual Reality and Breathing Exercises on Hemodialysis Patients' Symptoms and Quality of Life
A study testing routine hemodialysis, Breathing Exercise and Virtual Reality in people with Kidney Diseases, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- routine hemodialysis, Breathing Exercise and Virtual Reality
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırklareli Eğitim ve Araştırma Hastanesi
Kırklareli, Merkez, 39010
About this study
Official title: Evaluation of the Effects of Virtual Reality Glasses and Respiratory Exercises on Symptoms and Quality of Life Among Patients Receiving Hemodialysis Treatment
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.
Read more
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.
Read the 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;
- 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.
- 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:
- Normal breathing for 1 minute,
- Chest breathing 20-24 times (approximately 3 minutes),
- Diaphragmatic breathing (inhale through the nose and exhale through the nose) 20-24 times (approximately 3 minutes),
- Pursed lip breathing 16-20 times (approximately 2 minutes) (inhale through the nose and exhale through the mouth),
- Normal breathing for 1 minute
- 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:
- 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.
- 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
- Kidney Diseases
- Being tested
- routine hemodialysis, Breathing Exercise, Virtual Reality
- Keywords
- Hemodialysis, quality of life, general assessment of symptoms, virtual reality, breathing exercise
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine hemodialysisBehavioural
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 ExerciseBehavioural
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 RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | 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. Receives: Behavioral: routine hemodialysis |
| Breathing Exercise Group | Active comparator | 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. Receives: Behavioral: routine hemodialysis; Behavioral: Breathing Exercise |
| Virtual Reality Group | Active comparator | 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. Receives: Behavioral: routine hemodialysis; Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis Symptom Index (DSI)
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.
Measured: This form was completed by each patient three times in total, at one-week intervals
Secondary outcomes (1)
World Health Organization Quality of Life - Bref
World Health Organization Quality of Life Bref is the short version of the WHOQOL-100 to assess the health-related quality of life, which has efficient psychometric properties, valid and reliable for Turkish society. It is essential for epidemiological survey and international report has built for psychometric properties for 26 country where Turkey within. It has 4 domains; physical health, psychology, social relations and environment. Each question is answered on a 5-point Likert scale. The raw score is converted into a percentage system. The quality of life is interpreted as good as it gets closer to 100%.
Measured: This form was completed by each patient three times in total, at one-week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Aug 2021
- Primary completion15 May 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecehan Bulut, Trakya University
- Investigators
- Ecehan Bulut, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968130
- Sponsor's protocol ID
- TÜTF-BAEK-2021/01
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Virtual Reality Glasses and Respiratory Exercises on Symptoms and Quality of Life Among Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT06968130
- Acronym / sponsor ID
- TÜTF-BAEK-2021/01
- Conditions
- Kidney Diseases
- Keywords
- Hemodialysis, quality of life, general assessment of symptoms, virtual reality, breathing exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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.
- 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:
- Normal breathing for 1 minute,
- Chest breathing 20-24 times (approximately 3 minutes),
- Diaphragmatic breathing (inhale through the nose and exhale through the nose) 20-24 times (approximately 3 minutes),
- Pursed lip breathing 16-20 times (approximately 2 minutes) (inhale through the nose and exhale through the mouth),
- Normal breathing for 1 minute
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Behavioral: routine hemodialysisPatients 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 | Active comparator | Behavioral: routine hemodialysis, Behavioral: Breathing ExercisePatients 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 | Active comparator | Behavioral: routine hemodialysis, Device: Virtual RealityAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine hemodialysisPatients will receive routine hemodialysis without any additional intervention. The same scales will be administered at baseline and during two follow-ups one week apart. | Behavioural | Breathing Exercise Group, Virtual Reality Group, control group |
| Breathing ExercisePatients 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. | Behavioural | Breathing Exercise Group |
| Virtual RealityAfter 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. | Device | Virtual Reality Group |
Primary outcome
Dialysis Symptom Index (DSI)
Time frame: 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.
1 secondary outcome
World Health Organization Quality of Life - Bref
Time frame: This form was completed by each patient three times in total, at one-week intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ecehan Bulut principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine hemodialysis, Breathing Exercise and Virtual Reality in people with Kidney Diseases, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Symptom Index (DSI) (time frame: This form was completed by each patient three times in total, at one-week intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.