Hemodialysis PatientVirtualRealityNCT07622264
Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients
A study testing Virtual Reality Group and Routine Procedure in people with Hemodialysis Patient and Fistulas Arteriovenous, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effect of virtual reality (VR) goggles used during arteriovenous fistula (AVF) cannulation in hemodialysis patients on pain and anxiety levels. The study is designed as a parallel-group randomized controlled trial and will be conducted with 50 patients receiving treatment at a dialysis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patient, Fistulas Arteriovenous
- What is being tested?
- Virtual Reality Group and Routine Procedure
- 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
- 20 Jul 2025to 20 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Receiving treatment via AVF,
- Having no visual impairment,
- Giving voluntary consent.
Who cannot join
- Patients with catheter use,
- Communication problems,
- Antipsychotic medication use,
- Analgesic use in the last 12 hours,
- Failed (multiple) needle insertion attempts
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Daviva Private Konya Dialysis Center
Konya, Selçuklu, 42020
About this study
Official title: Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial
This study aims to determine the effect of virtual reality (VR) goggles used during arteriovenous fistula (AVF) cannulation in hemodialysis patients on pain and anxiety levels.
The study is designed as a parallel-group randomized controlled trial and will be conducted with 50 patients receiving treatment at a dialysis center. Participants will be randomly assigned to an experimental group (n=25) and a control group (n=25).
Patients in the experimental group will be shown visual-auditory content via VR goggles during AVF needle insertion, while the control group will receive routine care. Data will be collected using the Demographic Information Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI). Statistical analyses will include appropriate comparative and correlational tests to evaluate differences between groups and relationships between variables.
Read the detailed description
After generating the randomization list for participant allocation, the study materials will be prepared, including informed consent forms, the Descriptive Characteristics Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI).
Participants will be assigned to experimental and control groups according to the randomization list. In the experimental group, virtual reality intervention will be applied during AVF needle insertion, while the control group will receive standard care procedures.
To ensure standardization of the cannulation procedure, all patients in both groups will be cannulated using a 16-gauge arterial and venous needle, inserted at a 30°-45° angle and at least 5 cm from the fistula region, by the same certified hemodialysis nurse. The needle will be secured with hypoallergenic tape.
Fifteen minutes after fistula cannulation, outcome measurements will be performed using the Visual Analog Scale (VAS) and the State Anxiety Inventory (SAI).
- Conditions
- Hemodialysis Patient, Fistulas Arteriovenous
- Being tested
- Virtual Reality Group, Routine Procedure
- Keywords
- Hemodialysis, Virtual Reality, Pain, State Anxiety
- Medical subject headings
- Arteriovenous Fistula, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupDevice
Also called Virtual Reality
Prior to cannulation, SG goggles were worn, immersive visual/auditory content was shown during the procedure, and the goggles were removed 15 minutes after needle insertion for final measurements. To standardize the procedure, all needle insertions were performed by the same experienced nurse, using a size 16 needle, at least 5 cm away from the fistula site, and at an angle of 30°-45°.
Routine ProcedureOther
Only the clinic's routine procedures were followed.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Patients receive VR during cannulation Receives: Device: Virtual Reality Group |
| Control Group | Active comparator | Routine Procedure Receives: Other: Routine Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Measured: 15 minutes after AVF cannulation
Anxiety Level
Anxiety levels will be assessed using the State Anxiety Inventory (SAI). Higher scores indicate higher anxiety levels.
Measured: 15 minutes after AVF cannulation
Secondary outcomes (2)
Change in Pain Intensity from BaselineBaseline Values"
Change in VAS score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.
Measured: From 15 minutes before cannulation to 15 minutes after cannulation
Change in Anxiety Level from Baseline
Change in SAI score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.
Measured: From 15 minutes before cannulation to 15 minutes after cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start20 Jul 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622264
- Sponsor's protocol ID
- KTO Karatay University AVFSTL
- Acronym
- VirtualReality
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data is not shared, or may be shared only to a limited extent, due to patient privacy, ethical guidelines, and legal regulations (e.g., data protection). Protecting this data is critical to ensuring patient safety and confidence in research.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07622264
- Acronym / sponsor ID
- VirtualReality / KTO Karatay University AVFSTL
- Conditions
- Hemodialysis Patient, Fistulas Arteriovenous
- Keywords
- Hemodialysis, Virtual Reality, Pain, State Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 3 Jun 2026 (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.
This study aims to determine the effect of virtual reality (VR) goggles used during arteriovenous fistula (AVF) cannulation in hemodialysis patients on pain and anxiety levels.
The study is designed as a parallel-group randomized controlled trial and will be conducted with 50 patients receiving treatment at a dialysis center. Participants will be randomly assigned to an experimental group (n=25) and a control group (n=25).
Patients in the experimental group will be shown visual-auditory content via VR goggles during AVF needle insertion, while the control group will receive routine care. Data will be collected using the Demographic Information Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI). Statistical analyses will include appropriate comparative and correlational tests to evaluate differences between groups and relationships between variables.
Detailed description
After generating the randomization list for participant allocation, the study materials will be prepared, including informed consent forms, the Descriptive Characteristics Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI).
Participants will be assigned to experimental and control groups according to the randomization list. In the experimental group, virtual reality intervention will be applied during AVF needle insertion, while the control group will receive standard care procedures.
To ensure standardization of the cannulation procedure, all patients in both groups will be cannulated using a 16-gauge arterial and venous needle, inserted at a 30°-45° angle and at least 5 cm from the fistula region, by the same certified hemodialysis nurse. The needle will be secured with hypoallergenic tape.
Fifteen minutes after fistula cannulation, outcome measurements will be performed using the Visual Analog Scale (VAS) and the State Anxiety Inventory (SAI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality GroupPatients receive VR during cannulation |
| Control Group | Active comparator | Other: Routine ProcedureRoutine Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- Receiving treatment via AVF,
- Having no visual impairment,
- Giving voluntary consent.
Key exclusion criteria (5 listed)
- Patients with catheter use,
- Communication problems,
- Antipsychotic medication use,
- Analgesic use in the last 12 hours,
- Failed (multiple) needle insertion attempts
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 GroupAlso: Virtual RealityPrior to cannulation, SG goggles were worn, immersive visual/auditory content was shown during the procedure, and the goggles were removed 15 minutes after needle insertion for final measurements. To standardize the procedure, all needle insertions were performed by the same experienced nurse, using a size 16 needle, at least 5 cm away from the fistula site, and at an angle of 30°-45°. | Device | Virtual Reality Group |
| Routine ProcedureOnly the clinic's routine procedures were followed. | Other | Control Group |
Primary outcome
Pain Intensity
Time frame: 15 minutes after AVF cannulation
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Anxiety Level
Time frame: 15 minutes after AVF cannulation
Anxiety levels will be assessed using the State Anxiety Inventory (SAI). Higher scores indicate higher anxiety levels.
2 secondary outcomes
Change in Pain Intensity from BaselineBaseline Values"
Time frame: From 15 minutes before cannulation to 15 minutes after cannulation
Change in Anxiety Level from Baseline
Time frame: From 15 minutes before cannulation to 15 minutes after cannulation
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 3 Jun 2026.
- Individual participant dataSharing planned: No. Individual patient data is not shared, or may be shared only to a limited extent, due to patient privacy, ethical guidelines, and legal regulations (e.g., data protection). Protecting this data is critical to ensuring patient safety and confidence in research.
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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 Virtual Reality Group and Routine Procedure in people with Hemodialysis Patient and Fistulas Arteriovenous, run by KTO Karatay 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 4 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 3 Jun 2026. 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 Intensity (time frame: 15 minutes after AVF cannulation). 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 3 Jun 2026.