Clinical trial NCT06745765: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preoperative Anxiety
Keywords: Virtual reality
Preoperative care
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Anxiety change in STAI-S scale
timeFrame: At baseline (before VR), after 15 minutes, after 1 hour
Secondary outcomes:
measure: Change of anxiety (VAS-A score)
timeFrame: At baseline (before VR), after 15 minutes, after 1 hour
measure: Change in heart rate
timeFrame: At baseline (before VR), after 15 minutes, after 1 hour
measure: Change in blood pressure
timeFrame: At baseline (before VR), after 15 minutes, after 1 hour
measure: Patient satisfaction on a scale from 0 to 10
timeFrame: After 1 hour
measure: Operator satisfaction on a 0-10 scale
timeFrame: After 1 hour
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References: