Chronic Kidney DiseasesNCT05807906
The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients
A study testing virtual reality application in people with Chronic Kidney Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients. Hypotheses of the Research: H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients. 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?
- virtual reality application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2023to 31 May 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
- No diagnosis of neuropathic pain
- No sedatives, analgesics and sedatives are applied 3 hours before the application.
- Not taking recently taken antipsychotic drugs and tranquilizers,
- Deaf and visually impaired (to mark VAS pain)
- 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
- Multiple fistula puncture attempts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients
The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.
Hypotheses of the Research:
H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.
H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.
In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.
Read the detailed description
- Demographic/medical data will initially be recorded prior to fistula puncture.
- The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
- Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
- The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
- The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.
- Conditions
- Chronic Kidney Diseases
- Being tested
- virtual reality application
- 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.
virtual reality applicationOther
The patient will continue to monitor the virtual reality application during the fistula puncture procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment. Receives: Other: virtual reality application |
| Control Group | No intervention | Routine nursing care and diet compliance narration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-VAS Scale
VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.
Measured: Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain 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 posted11 Apr 2023
- Study start17 Apr 2023
- Primary completion31 May 2023
- Study completion31 May 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 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
- NCT05807906
- Sponsor's protocol ID
- E1-22-2882
- Status last verified
- Feb 2024
- First submitted
- 3 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 Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05807906
- Acronym / sponsor ID
- E1-22-2882
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 11 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.
The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.
Hypotheses of the Research:
H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.
H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.
In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.
Detailed description
- Demographic/medical data will initially be recorded prior to fistula puncture.
- The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
- Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
- The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
- The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: virtual reality applicationvirtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment. |
| Control Group | No intervention | –Routine nursing care and diet compliance narration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No diagnosis of neuropathic pain
- No sedatives, analgesics and sedatives are applied 3 hours before the application.
- Not taking recently taken antipsychotic drugs and tranquilizers,
- Deaf and visually impaired (to mark VAS pain)
- Without cognitive and psychiatric diagnosis
Key exclusion criteria (6 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 |
|---|---|---|
| virtual reality applicationThe patient will continue to monitor the virtual reality application during the fistula puncture procedure. | Other | Intervention Group |
Primary outcome
Pain-VAS Scale
Time frame: Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain scale score will measure fifth week.
VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.
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
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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 virtual reality application 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 6 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. 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?
Pain-VAS Scale (time frame: Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain scale score will measure fifth 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 28 Feb 2024.