Virtual Reality for Anxiety in Interventional Radiology Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VR

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

Group Type EXPERIMENTAL

Virtual reality headset

Intervention Type DEVICE

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

NO VR

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality headset

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No