Virtual Reality for Anxiety in Interventional Radiology Procedures

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Anxiety change in STAI-S scale [Time frame: At baseline (before VR), after 15 minutes, after 1 hour]

Secondary outcome measures (5)

• Change of anxiety (VAS-A score) [Time frame: At baseline (before VR), after 15 minutes, after 1 hour]
• Change in heart rate [Time frame: At baseline (before VR), after 15 minutes, after 1 hour]
• Change in blood pressure [Time frame: At baseline (before VR), after 15 minutes, after 1 hour]
• Patient satisfaction on a scale from 0 to 10 [Time frame: After 1 hour]
• Operator satisfaction on a 0-10 scale [Time frame: After 1 hour]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Italy · 1 center

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Identifiers

NCT: NCT06745765 · CE AVEC: 622/2024/Sper/IOR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗