Virtual Reality for Anxiety in Interventional Radiology Procedures (VR-IR)

Effects of Virtual Reality in the Management of Anxiety in Patients Undergoing Interventional Radiology Procedures: Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Device: Virtual reality headset

Detailed Description

Patients enrolled and assigned to group 1 will wear the virtual reality visor in the induction room, before entering the Angio Suite in which the procedure will take place. The study requires that before and at the end of the procedure, a measurement of blood pressure and heart rate in order to measure the change in the patient's anxiety state. At the end of the procedure, they will be administered satisfaction tests to interventional radiologists and patients. The viewers in question are Meta Quest 2. Through the use of these viewers, the patient will will watch a VR video containing music and natural images that can promote relaxation in preparation for the procedure.

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giancarlo Facchini, Medicine and Surgery; Phone Number: +39 0516366836; Email: giancarlo.facchini@ior.it
• Study Contact Backup: Name: Michela Carta, Biotechnology; Phone Number: +39 0516366376; Email: michela.carta@ior.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40136
      • Recruiting
      • IRCCS Istituto Ortopedico Rizzoli
      • Contact: Giancarlo Facchini, Medicine and Surgery; Phone Number: +39 0516366836; Email: giancarlo.facchini@ior.it
      • Contact: Michela Carta, Biotechnology; Phone Number: +39 0516366376; Email: michela.carta@ior.it
      • Principal Investigator: Giancarlo Facchini, Medicine and Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR; Patients will use virtual reality before the procedure in addition to usual preoperative care.	Device: Virtual reality headset; Patients will use virtual reality before the procedure in addition to usual preoperative care.
No Intervention: NO VR; Patients will not use virtual reality; hence, they will experience usual preoperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety change in STAI-S scale	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.	At baseline (before VR), after 15 minutes, after 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of anxiety (VAS-A score)	The VAS-A scale, short for "Visual Analogue Scale for Anxiety," is an instrument used in the subjective assessment of anxiety. It consists of a horizontal line usually about 10 centimeters long, with ends marked by two descriptions opposites related to the degree of perceived anxiety. For example, one end may be labeled "no anxiety" and on the other "extreme anxiety." Scores will be assessed before and after the use of virtual reality (for patients in VR group) and after the procedure.	At baseline (before VR), after 15 minutes, after 1 hour
Change in heart rate	Heart rate will be measured before and after the use of virtual reality (for patients in the Vr group) and after the procedure. Heart rate may exceed 100 bpm during an anxiety episode (range of normal at rest 60-100 bpm).	At baseline (before VR), after 15 minutes, after 1 hour
Change in blood pressure	An anxious state will be considered as an increase in pressure relative to normal (generally considered to be around 120/80 mmHg), thus, indicatively, values of 140/90 mmHg or more. Blood pressure will be measured before and after the use of virtual reality (for patients in VR group) and after the procedure.	At baseline (before VR), after 15 minutes, after 1 hour
Patient satisfaction on a scale from 0 to 10	0=totally unsatisfied 10= totally satisfied	After 1 hour
Operator satisfaction on a 0-10 scale	0 = totally unsatisfied with patient's compliance 10 = totally satisfied with patient's compliance	After 1 hour

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Preoperative care; Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CE AVEC: 622/2024/Sper/IOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No