Chronic Kidney DiseasesNCT05814679
Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
A study testing Relaxation with virtual reality and Attention match in people with Chronic Kidney Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Based on the task of providing the comfort of the patient, which is an indispensable part of the nursing profession, which many nurse theorists emphasize, there has been no study in the literature on the determination of the effect of virtual relaxation, which can be effective on the fatigue and comfort levels of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Relaxation with virtual reality and Attention match
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis treatment for the last 6 months
- Receiving four-hour hemodialysis treatment three times a week
- 18 years or older
- Deaf and visually impaired
- Without cognitive and psychiatric diagnosis
- Open to communication and cooperation
- Patients who agreed to participate in the study
Who cannot join
- Kidney transplant
- Discomfort due to virtual reality glasses
- Suspected/diagnosed COVID-19
- Patients who want to leave the study voluntarily
- Death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
Based on the task of providing the comfort of the patient, which is an indispensable part of the nursing profession, which many nurse theorists emphasize, there has been no study in the literature on the determination of the effect of virtual relaxation, which can be effective on the fatigue and comfort levels of patients receiving hemodialysis treatment. Therefore, the aim of this study is to examine the effect of virtual reality and relaxation on fatigue and comfort in hemodialysis patients.
Read the detailed description
The patient will be prepared for relaxation with virtual reality and will be given a comfortable sitting position.
The patient will watch the relaxation practice with virtual reality once during the hemodialysis treatment.
The application will be terminated with the expiration of the virtual reality relaxation video.
Fatigue and comfort score will be measured after the application.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Relaxation with virtual reality, Attention match
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation with virtual realityOther
In this research, a virtual reality relaxation video will be used in which the natural wonders are presented to the audience in an immersive environment.
Attention matchOther
kidney function instruction
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The patient will relax with virtual reality in the hemodialysis center with the researcher. Receives: Other: Relaxation with virtual reality |
| Control Group | Placebo comparator | The patients in the control group will be given a training on the functions of the kidneys. Receives: Other: Attention match |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
In the study, fatigue symptom will be measured with the fatigue severity scale.
Measured: Assessing change of fatigue severity scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and fatigue severity scale score will measure fifth week.
Hemodialysis Comfort Scale
In the study, hemodialysis comfort will be measured with the hemodialysis comfort scale.
Measured: Assessing change of fatigue comfort scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and comfort scale score will measure fifth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start31 May 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe Altinok Ersoy, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814679
- Sponsor's protocol ID
- E1-22-3047
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2023
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05814679
- Acronym / sponsor ID
- E1-22-3047
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Apr 2023 (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.
Based on the task of providing the comfort of the patient, which is an indispensable part of the nursing profession, which many nurse theorists emphasize, there has been no study in the literature on the determination of the effect of virtual relaxation, which can be effective on the fatigue and comfort levels of patients receiving hemodialysis treatment. Therefore, the aim of this study is to examine the effect of virtual reality and relaxation on fatigue and comfort in hemodialysis patients.
Detailed description
The patient will be prepared for relaxation with virtual reality and will be given a comfortable sitting position.
The patient will watch the relaxation practice with virtual reality once during the hemodialysis treatment.
The application will be terminated with the expiration of the virtual reality relaxation video.
Fatigue and comfort score will be measured after the application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Relaxation with virtual realityThe patient will relax with virtual reality in the hemodialysis center with the researcher. |
| Control Group | Placebo comparator | Other: Attention matchThe patients in the control group will be given a training on the functions of the kidneys. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Receiving hemodialysis treatment for the last 6 months
- Receiving four-hour hemodialysis treatment three times a week
- 18 years or older
- Deaf and visually impaired
- Without cognitive and psychiatric diagnosis
Key exclusion criteria (5 listed)
- Kidney transplant
- Discomfort due to virtual reality glasses
- Suspected/diagnosed COVID-19
- Patients who want to leave the study voluntarily
- Death
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 |
|---|---|---|
| Relaxation with virtual realityIn this research, a virtual reality relaxation video will be used in which the natural wonders are presented to the audience in an immersive environment. | Other | Intervention Group |
| Attention matchkidney function instruction | Other | Control Group |
Primary outcome
Fatigue Severity Scale
Time frame: Assessing change of fatigue severity scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and fatigue severity scale score will measure fifth week.
In the study, fatigue symptom will be measured with the fatigue severity scale.
Hemodialysis Comfort Scale
Time frame: Assessing change of fatigue comfort scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and comfort scale score will measure fifth week.
In the study, hemodialysis comfort will be measured with the hemodialysis comfort scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation with virtual reality and Attention match in people with Chronic Kidney Diseases, run by Hacettepe 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 5 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fatigue Severity Scale (time frame: Assessing change of fatigue severity scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and fatigue severity scale score will measure fifth week.). The study lists 2 primary outcomes in all. 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 28 Feb 2024.