Peripheral AngioplastyPhase 2/3VRPAINNCT07057752
Virtual Reality for Pain and Anxiety Relief During Peripheral Angioplasty
A Phase 2/3 study testing Virtual Reality and dexketoprofen + midazolam in people with Peripheral Angioplasty and Pain Management, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral arterial disease can cause serious leg pain and discomfort. During treatment with angioplasty, patients often feel pain and anxiety because the procedure is usually done with local anesthesia and no sedation. Virtual reality (VR) may help reduce these feelings by distracting patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Angioplasty, Pain Management, Virtual Reality
- What is being tested?
- Virtual Reality and dexketoprofen + midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 29 Oct 2025
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective peripheral angioplasty
- Can cooperate and appropriate for wearing VR glasses
Who cannot join
- Undergoing emergency peripheral angioplasty
- With neurological and psychiatric conditions that prevent reliable assessment of pain or anxiety scores
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu Education and Research Hospital
Kastamonu, Kastamonu, 37200
About this study
Official title: Effect of Virtual Reality Distraction in Reducing Patients' Pain and Anxiety During Peripheral Arterial Angioplasty: a Randomized Prospective Study
Peripheral arterial disease can cause serious leg pain and discomfort. During treatment with angioplasty, patients often feel pain and anxiety because the procedure is usually done with local anesthesia and no sedation. Virtual reality (VR) may help reduce these feelings by distracting patients.
This study will test whether using VR glasses during peripheral angioplasty can lower patients' pain and anxiety. Patients will be randomly divided into two groups: one will use VR, the other will not. Pain and anxiety will be measured at different times during the procedure. The need for extra pain or anxiety medication and overall satisfaction will also be recorded.
- Conditions
- Peripheral Angioplasty, Pain Management, Virtual Reality
- Being tested
- Virtual Reality, dexketoprofen + midazolam
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Virtual reality (VR) will be applied to patients in this group in addition to painkillers. VR is a non-pharmacological method that uses special glasses to create an immersive visual and auditory experience. It helps distract patients from the procedure and may reduce pain and anxiety.
dexketoprofen + midazolamDrug
Patients in this group will be treated with dexketoprofen as a painkiller and midazolam as an anxiolytic, if needed. This combination aims to reduce both pain and anxiety during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Virtual reality glasses will be applied to patients in this group in addition to painkillers Receives: Other: Virtual Reality |
| Routine treatment group | Active comparator | Patients in this group will be administered painkillers routinely in the hospital. Receives: Drug: dexketoprofen + midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Pain level will be measured with the Numerical Rating Scale (NRS). It ranges between minimum 0 and maximum 10 points. 0 point reffers no pain, 10 points reffer most serious pain.
Measured: 1 day
State Anxiety Inventory-6 (STAI-6)
Anxiety level was measured with the State Anxiety Inventory-6 (STAI-6). After a correction formula it ranges between minimum 20 and maximum 80 points. 20 points reffer lower anxiety, 80 points reffer higher anxiety.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Aug 2025
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral AngioplastyStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail DAL, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057752
- Sponsor's protocol ID
- KastamonuUni
- Acronym
- VRPAIN
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Distraction in Reducing Patients' Pain and Anxiety During Peripheral Arterial Angioplasty: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07057752
- Acronym / sponsor ID
- VRPAIN / KastamonuUni
- Conditions
- Peripheral Angioplasty, Pain Management, Virtual Reality
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 10 Jul 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.
Peripheral arterial disease can cause serious leg pain and discomfort. During treatment with angioplasty, patients often feel pain and anxiety because the procedure is usually done with local anesthesia and no sedation. Virtual reality (VR) may help reduce these feelings by distracting patients.
This study will test whether using VR glasses during peripheral angioplasty can lower patients' pain and anxiety. Patients will be randomly divided into two groups: one will use VR, the other will not. Pain and anxiety will be measured at different times during the procedure. The need for extra pain or anxiety medication and overall satisfaction will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityVirtual reality glasses will be applied to patients in this group in addition to painkillers |
| Routine treatment group | Active comparator | Drug: dexketoprofen + midazolamPatients in this group will be administered painkillers routinely in the hospital. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective peripheral angioplasty
- Can cooperate and appropriate for wearing VR glasses
Key exclusion criteria (2 listed)
- Undergoing emergency peripheral angioplasty
- With neurological and psychiatric conditions that prevent reliable assessment of pain or anxiety scores
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 RealityVirtual reality (VR) will be applied to patients in this group in addition to painkillers. VR is a non-pharmacological method that uses special glasses to create an immersive visual and auditory experience. It helps distract patients from the procedure and may reduce pain and anxiety. | Other | Virtual Reality |
| dexketoprofen + midazolamPatients in this group will be treated with dexketoprofen as a painkiller and midazolam as an anxiolytic, if needed. This combination aims to reduce both pain and anxiety during the procedure. | Drug | Routine treatment group |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: 1 day
Pain level will be measured with the Numerical Rating Scale (NRS). It ranges between minimum 0 and maximum 10 points. 0 point reffers no pain, 10 points reffer most serious pain.
State Anxiety Inventory-6 (STAI-6)
Time frame: 1 day
Anxiety level was measured with the State Anxiety Inventory-6 (STAI-6). After a correction formula it ranges between minimum 20 and maximum 80 points. 20 points reffer lower anxiety, 80 points reffer higher anxiety.
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 19 Nov 2025.
- Individual participant dataSharing planned: Yes. yes
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VITUS Post-Market Registry
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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 Phase 2/3 study testing Virtual Reality and dexketoprofen + midazolam in people with Peripheral Angioplasty and Pain Management, run by Kastamonu 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 2 inclusion and 2 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 19 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numerical Rating Scale (NRS) (time frame: 1 day). 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 19 Nov 2025.