HemodialysisNCT06458608
Hemodiasis Patients Using Virtual Reality Video
A study testing virtual reality glasses in people with Hemodialysis and Symptoms, run by Dilan aktepe coşar at 1 site in Turkey (Türkiye).
Trial summary
VR, with its developing technology, is a new technique used in the healthcare industry combined with cognitive technology to reduce the symptoms experienced by patients and to relieve the patient. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Symptoms, Virtual Reality
- What is being tested?
- virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 1 Jun 2024
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily over 18 years
Who cannot join
- reluctant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gümüşhane Üniversitesi
Gümüşhane, Kelkit, 2900
About this study
Official title: Determining the Effect of Virtual Reality-Based Videos on Hemodialysis Symptoms, Vital Signs and Comfort in Hemodialysis Patients
VR, with its developing technology, is a new technique used in the healthcare industry combined with cognitive technology to reduce the symptoms experienced by patients and to relieve the patient. This study investigates whether virtual tour environments created using virtual reality glasses have an effect on patients\' vital signs, symptoms and comfort during the hemodialysis session. It is aimed to evaluate the effect of Virtual Reality Based Videos applied during hemodialysis treatment on Hemodialysis Symptoms, vital signs and Comfort.
Read the detailed description
Hemodialysis (HD) is one of the treatment options used to regulate renal functions in the treatment of chronic renal failure. In hemodialysis, patients have to cope with many problems during the treatment process as well as the disease. In addition, patients require HD treatment, which lasts three to four hours, three times a week on average. Factors such as having to go to a dialysis center for these treatments, patients having to continue their lives depending on the machine, restriction of movements during the session, increased dependency of the patient, deterioration in their adaptation to professional and social relationships affect the patients\' daily life activities and reduce their comfort. With the developing technology, virtual reality, a new technique in the healthcare industry, has begun to be used in nursing care in order to reduce the symptoms experienced by patients and to comfort the patient.
The virtual reality device removes the patient from the environment with the glasses and headphones attached to the person\'s head, along with the image on the screen and simultaneous sounds, and focuses his/her attention on the virtual video images. This study was planned as a randomized controlled study to evaluate the effect of virtual reality-based videos on hemodialysis symptoms and comfort in hemodialysis patients. The research was planned to be conducted with 50 hemodialysis patients. \"Patient Introduction Form\", \"Dialysis Symptom Index (DSI)\", \"Vital Signs Monitoring Form\", \"Hemodialysis Comfort Scale Version II\" will be used to collect data. After the scales were applied, patients in the experimental group were exposed to virtual reality glasses for 30 minutes, twice a week for 8 weeks. The video will be watched. At the end of 8 weeks, the scales will be applied again and compared with the initial scale results.
As a result, in line with the findings obtained from the research, the effect of virtual reality application on dialysis symptoms, vital signs and comfort during hemodialysis treatment will be determined and suggestions will be made to encourage patients to use virtual reality methods in the environments where they are treated.
- Conditions
- Hemodialysis, Symptoms, Virtual Reality, Comfort
- Being tested
- virtual reality glasses
- Keywords
- Hemodialysis, Virtual Reality Symptoms, Vital Signs, Comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
virtual reality glasses
| Study group | Role | What they receive |
|---|---|---|
| group that watched virtual reality videos | Experimental | Pre-test data for all participants before treatment in the waiting room of the hemodialysis unit, "Structured Patient Introduction Form" (Annex-1), "Dialysis Symptom Index (DSI)" (Appendix 2), "Vital Signs Monitoring Form" (Appendix). 3),''Hemodialysis Comfort Scale Version II'' (Appendix 4) face to face interview for approximately 15 minutes is run as learning pre-test data. The intervention group was also given information about the use of virtual reality and the video content to be watched. Videos are transferred to virtual reality glasses and presented with the headset. After the hemodialysis treatment starts, the intervention psychologist researcher will watch 30 scan videos of approximately half an hour during the dialysis period, 2 sessions a week for 8 weeks, and a Turkey promotional short film presented by the researchers visually and audibly in VR (VR Shineco 3d). Receives: Device: virtual reality glasses |
| The group that is not allowed to watch virtual reality videos | Experimental | The hemodialysis patients in this group were not shown anything. Only data collection forms were administered to the patients before the study (pretest) and at the end of the study. Receives: Device: virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodialysis Comfort Scale Version II (HDCS Version II)
The scale consists of a total of 26 items and a 5-point Likert type. HDCS Version II has six subscales (physical relaxation, physical comfort, psychospiritual comfort, psychospiritual transcendence, environmental transcendence, and sociocultural comfort).
Measured: 8 week
Secondary outcomes (2)
Dialysis Symptom Index (DSI) (Appendix 2)
It consists of a total of 30 items that evaluate the emotional and physical symptoms of dialysis patients and the severity of these symptoms.
Measured: 8 week
Vital Signs Monitoring Form
It is a form in which patients' BP, respiratory rate, pulse, temperature and oxygen saturation values are measured and recorded once a week before and after the HD procedure.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start30 May 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- No study could be taken as a reference due to the number of samples, the amount of error in the G\*Power 3.1.9.6 program, α=0.05, and the lack of a previous study with 2 groups on the subject; With an effect size of 0.80 and the power of the targeted test being 0.80 (80%), a total of 42 patients (21 for each group) were calculated for two groups (experimental group, control group). Considering situations such as wanting to leave the study or death during the research, each group will be increased by 20% and a total of 50 patients will be included in the study, 25 patients for each group.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilan aktepe coşar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilan aktepe coşar, Gümüşhane Universıty
- Investigators
- Dilan aktepe coşar, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458608
- Sponsor's protocol ID
- Hm20240001
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Virtual Reality-Based Videos on Hemodialysis Symptoms, Vital Signs and Comfort in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06458608
- Acronym / sponsor ID
- Hm20240001
- Conditions
- Hemodialysis, Symptoms, Virtual Reality, Comfort
- Keywords
- Hemodialysis, Virtual Reality Symptoms, Vital Signs, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dilan aktepe coşarUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 13 Jun 2024 (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.
VR, with its developing technology, is a new technique used in the healthcare industry combined with cognitive technology to reduce the symptoms experienced by patients and to relieve the patient. This study investigates whether virtual tour environments created using virtual reality glasses have an effect on patients\' vital signs, symptoms and comfort during the hemodialysis session. It is aimed to evaluate the effect of Virtual Reality Based Videos applied during hemodialysis treatment on Hemodialysis Symptoms, vital signs and Comfort.
Detailed description
Hemodialysis (HD) is one of the treatment options used to regulate renal functions in the treatment of chronic renal failure. In hemodialysis, patients have to cope with many problems during the treatment process as well as the disease. In addition, patients require HD treatment, which lasts three to four hours, three times a week on average. Factors such as having to go to a dialysis center for these treatments, patients having to continue their lives depending on the machine, restriction of movements during the session, increased dependency of the patient, deterioration in their adaptation to professional and social relationships affect the patients\' daily life activities and reduce their comfort. With the developing technology, virtual reality, a new technique in the healthcare industry, has begun to be used in nursing care in order to reduce the symptoms experienced by patients and to comfort the patient.
The virtual reality device removes the patient from the environment with the glasses and headphones attached to the person\'s head, along with the image on the screen and simultaneous sounds, and focuses his/her attention on the virtual video images. This study was planned as a randomized controlled study to evaluate the effect of virtual reality-based videos on hemodialysis symptoms and comfort in hemodialysis patients. The research was planned to be conducted with 50 hemodialysis patients. \"Patient Introduction Form\", \"Dialysis Symptom Index (DSI)\", \"Vital Signs Monitoring Form\", \"Hemodialysis Comfort Scale Version II\" will be used to collect data. After the scales were applied, patients in the experimental group were exposed to virtual reality glasses for 30 minutes, twice a week for 8 weeks. The video will be watched. At the end of 8 weeks, the scales will be applied again and compared with the initial scale results.
As a result, in line with the findings obtained from the research, the effect of virtual reality application on dialysis symptoms, vital signs and comfort during hemodialysis treatment will be determined and suggestions will be made to encourage patients to use virtual reality methods in the environments where they are treated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- No study could be taken as a reference due to the number of samples, the amount of error in the G*Power 3.1.9.6 program, α=0.05, and the lack of a previous study with 2 groups on the subject; With an effect size of 0.80 and the power of the targeted test being 0.80 (80%), a total of 42 patients (21 for each group) were calculated for two groups (experimental group, control group). Considering situations such as wanting to leave the study or death during the research, each group will be increased by 20% and a total of 50 patients will be included in the study, 25 patients for each group.
| Arm | Type | Receives |
|---|---|---|
| group that watched virtual reality videos | Experimental | Device: virtual reality glassesPre-test data for all participants before treatment in the waiting room of the hemodialysis unit, "Structured Patient Introduction Form" (Annex-1), "Dialysis Symptom Index (DSI)" (Appendix 2), "Vital Signs Monitoring Form" (Appendix). 3),''Hemodialysis Comfort Scale Version II'' (Appendix 4) face to face interview for approximately 15 minutes is run as learning pre-test data. The intervention group was also given information about the use of virtual reality and the video content to be watched. Videos are transferred to virtual reality glasses and presented with the headset. After the hemodialysis treatment starts, the intervention psychologist researcher will watch 30 scan videos of approximately half an hour during the dialysis period, 2 sessions a week for 8 weeks, and a Turkey promotional short film presented by the researchers visually and audibly in VR (VR Shineco 3d). |
| The group that is not allowed to watch virtual reality videos | Experimental | Device: virtual reality glassesThe hemodialysis patients in this group were not shown anything. Only data collection forms were administered to the patients before the study (pretest) and at the end of the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntarily over 18 years
Key exclusion criteria (1 listed)
- reluctant
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 |
|---|---|---|
| virtual reality glassesvirtual reality glasses | Device | The group that is not allowed to watch virtual reality videos, group that watched virtual reality videos |
Primary outcome
Hemodialysis Comfort Scale Version II (HDCS Version II)
Time frame: 8 week
The scale consists of a total of 26 items and a 5-point Likert type. HDCS Version II has six subscales (physical relaxation, physical comfort, psychospiritual comfort, psychospiritual transcendence, environmental transcendence, and sociocultural comfort).
2 secondary outcomes
Dialysis Symptom Index (DSI) (Appendix 2)
Time frame: 8 week
Vital Signs Monitoring Form
Time frame: 8 week
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 13 Jun 2024.
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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.
Dilan aktepe coşar principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses in people with Hemodialysis and Symptoms, run by Dilan aktepe coşar 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 1 inclusion and 1 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 13 Jun 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. 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?
Hemodialysis Comfort Scale Version II (HDCS Version II) (time frame: 8 week). 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 Jun 2024.