Virtual Reality for Pain and Anxiety Relief During Peripheral Angioplasty

NCT07057752 | Completed Phase 2

• 1 other identifier: KastamonuUni
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Angioplasty; Pain Management; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Virtual reality glasses will be applied to patients in this group in addition to painkillers

Other: Virtual Reality

Routine treatment group

ACTIVE COMPARATOR

Patients in this group will be administered painkillers routinely in the hospital.

Drug: dexketoprofen + midazolam

Interventions

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.

Virtual Reality

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.

Routine treatment group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu Education and Research Hospital

Kastamonu, Kastamonu, 37200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

dexketoprofen trometamol; Midazolam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Literally: Doctor Teaching Member

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 10, 2025
• Study Start: August 1, 2025
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available persistantly on 1.1.2026.
• Access Criteria: Upon reasonable request principal investigator will share the data.

Locations

TU (1)