Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Virtual reality glasses will be applied to patients in this group in addition to painkillers |
|
| Routine treatment group | Active Comparator | Patients in this group will be administered painkillers routinely in the hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kastamonu Education and Research Hospital | Kastamonu | Kastamonu | 37200 | Turkey (Türkiye) |
yes
Not provided
Data will become available persistantly on 1.1.2026.
Upon reasonable request principal investigator will share the data.
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| dexketoprofen + midazolam | Drug | 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. |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |