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OpenTrials
Completed

NCT Number: NCT07057752

Virtual Reality for Pain and Anxiety Relief During Peripheral Angioplasty

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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Key information

Conditions

Peripheral Angioplasty Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Virtual Reality

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kastamonu Education and Research Hospital

Kastamonu, 37200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kastamonu University

Other

Registry information

Official study title

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

Acronym: VRPAIN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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