Virtual Reality for Anxiety in Interventional Radiology Procedures

NCT06745765 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2024-11-01

Last updated

2026-05-11

Condition(s) studied

Preoperative Anxiety

Investigational drug(s) / intervention(s)

Virtual reality headset

Virtual reality headset: Patients will use virtual reality before the procedure in addition to usual preoperative care.

Study summary

The goal of this clinical trial is to learn if virtual reality works to reduce anxiety in patients undergoing interventional radiology procedures. The main questions it aims to answer are:

Does virtual reality lower anxiety in patients undegoing minimally invasive procedures? Can it help the platient's compliance and operators' satisfaction? Researchers will compare virtual reality to usual preoperative care to see if virtual reality is effective.

Participants will:

Use virtual reality for 20 minutes before the intervention starts. Complete questionnaires before and after the procedure.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Indication to CT-guided biopsy in local anesthesia * Informed consent signature Exclusion Criteria: * Lack of patient consent to trial. * Lack of eligibility to perform CT-guided needle biopsy, or eligibility to perform the procedure but with administration of general anesthesia or sedation. * patients who do not speak Italian or English will be excluded; * patients with visual and/or hearing impairment; * patients on analgesics or anxiolytics; * patients with the following conditions: dementia, psychiatric disorders; headache, dizziness, recent head injury, epilepsy, and other conditions in which the application of VR glasses has been judged to be potentially harmful; and when the topical anesthetic (lidocaine and prilocaine \[eutectic mixture of local anesthetic (EMLA)\]) or tetracaine (Ametop) was not properly applied before surgery.

Primary outcome measure(s)

Anxiety change in STAI-S scale — At baseline (before VR), after 15 minutes, after 1 hour
This subscale measures state anxiety, which is the anxiety temporary that an individual experiences in a specific situation. È designed to assess an individual's reaction to a particular event or situation particular moment at a specific time. Questions are phrased to reflect feelings such as tension, worry, agitation, and nervousness. Each item is formulated as a statement to which individuals must respond by indicating their level of agreement or discomfort on a 4-point scale. Scoring system: * 20-37: Low Anxiety * 38-44: Moderate anxiety * 45-80: High anxiety A difference of at least 3 points on the scale between the two groups is considered significant. Scores will be assessed before and after the use of virtual reality (for patients in VR group) and after the procedure.

Trial sites (1)

Facility	City	Region	Status
IRCCS Istituto Ortopedico Rizzoli	Bologna	Bologna	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06745765 on ClinicalTrials.gov ↗ ← All trials in Italy