Virtual Reality for Pain and Anxiety Relief During Peripheral Angioplasty

Not Applicable

Not yet recruiting

• Conditions: Peripheral Angioplasty; Pain Management; Virtual Reality
• Interventions: Other: Virtual Reality; Drug: dexketoprofen + midazolam

• Registration Number: NCT07057752
• Lead Sponsor: Kastamonu University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-22
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-05
• Last Update Submitted: 2025-07-05
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Study Start: 2025-08-01
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality	Virtual reality glasses will be applied to patients in this group in addition to painkillers
Routine treatment group	dexketoprofen + midazolam	Patients in this group will be administered painkillers routinely in the hospital.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kastamonu Education and Research Hospital; 🇹🇷 Kastamonu, Turkey