Virtual Reality for Pain and Anxiety Relief During Peripheral Angioplasty

NCT07057752 — Phase 2 / Phase 3, Completed, 52 participants, Kastamonu University

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Effect of Virtual Reality Distraction in Reducing Patients' Pain and Anxiety During Peripheral Arterial Angioplasty: a Randomized Prospective Study

Registry	NCT07057752, acronym VRPAIN
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	52 (Actual)
Sponsor	Kastamonu University (Other)
Conditions	Peripheral Angioplasty, Pain Management, Virtual Reality
Interventions	Virtual Reality, dexketoprofen + midazolam (Other, drug)
Dates	start 2025-08-01, primary completion 2025-10-29, completion 2025-10-29, first posted 2025-07-10, last updated 2025-11-19
Locations	1 site in Turkey (Türkiye)

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Virtual Reality	Experimental	Other: Virtual Reality	Virtual reality glasses will be applied to patients in this group in addition to painkillers
Routine treatment group	Active comparator	Drug: dexketoprofen + midazolam	Patients in this group will be administered painkillers routinely in the hospital.

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.
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.

+Outcome measures

Primary outcomes

Numerical Rating Scale (NRS) [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) [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.

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

* Undergoing elective peripheral angioplasty
* Can cooperate and appropriate for wearing VR glasses

Exclusion Criteria:

* Undergoing emergency peripheral angioplasty
* With neurological and psychiatric conditions that prevent reliable assessment of pain or anxiety scores

+Locations (1)

Facility	City	Country	Status
Kastamonu Education and Research Hospital	Kastamonu, Kastamonu	Turkey (Türkiye)