Virtual Reality for Anxiety in Interventional Radiology Procedures

NCT06745765 | Recruiting

• 1 other identifier: CE AVEC: 622/2024/Sper/IOR
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoperative Anxiety

Keywords

Virtual reality; Preoperative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of anxiety (VAS-A score)

  At baseline (before VR), after 15 minutes, after 1 hour

• Change in heart rate

  At baseline (before VR), after 15 minutes, after 1 hour

• Change in blood pressure

  At baseline (before VR), after 15 minutes, after 1 hour

• Patient satisfaction on a scale from 0 to 10

  After 1 hour

• Operator satisfaction on a 0-10 scale

  After 1 hour

Study Arms (2)

VR

EXPERIMENTAL

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

Device: Virtual reality headset

NO VR

NO INTERVENTION

Patients will not use virtual reality; hence, they will experience usual preoperative care.

Interventions

Virtual reality headset DEVICE

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

VR

Eligibility Criteria

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

You may qualify if:

• Indication to CT-guided biopsy in local anesthesia
• Informed consent signature

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

RECRUITING

Central Study Contacts

Giancarlo Facchini, Medicine and Surgery

CONTACT

+39 0516366836; giancarlo.facchini@ior.it

Michela Carta, Biotechnology

CONTACT

+39 0516366376; michela.carta@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)