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NCT Number: NCT06745765

Virtual Reality for Anxiety in Interventional Radiology Procedures

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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Key information

Conditions

Preoperative Anxiety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Giancarlo Facchini, Medicine and Surgery

CONTACT

[email protected]

+39 0516366836

Giancarlo Facchini, Medicine and Surgery

PRINCIPAL_INVESTIGATOR

Michela Carta, Biotechnology

CONTACT

[email protected]

+39 0516366376

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Headset

Device

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

Primary outcomes

  1. Anxiety change in STAI-S scale

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

    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.

Secondary outcomes

  1. Change of anxiety (VAS-A score)

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

    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.

  2. Change in heart rate

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

    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).

  3. Change in blood pressure

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

    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.

  4. Patient satisfaction on a scale from 0 to 10

    Time frame: After 1 hour

    0=totally unsatisfied 10= totally satisfied

  5. Operator satisfaction on a 0-10 scale

    Time frame: After 1 hour

    0 = totally unsatisfied with patient's compliance 10 = totally satisfied with patient's compliance

Study contacts

Contact information is provided by the study sponsor or research team.

Giancarlo Facchini, Medicine and Surgery

CONTACT

[email protected]

+39 0516366836

Michela Carta, Biotechnology

CONTACT

[email protected]

+39 0516366376

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: VR-IR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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