Preoperative AnxietyVR-IRNCT06745765
Virtual Reality for Anxiety in Interventional Radiology Procedures
A study testing Virtual reality headset in people with Preoperative Anxiety, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication to CT-guided biopsy in local anesthesia
- Informed consent signature
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, 40136
Giancarlo Facchini, Medicine and Surgery, +39 0516366836, giancarlo.facchini@ior.it
Michela Carta, Biotechnology, +39 0516366376, michela.carta@ior.it
About this study
Official title: Effects of Virtual Reality in the Management of Anxiety in Patients Undergoing Interventional Radiology Procedures: Randomized Study
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.
Read the 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.
- Conditions
- Preoperative Anxiety
- Being tested
- Virtual reality headset
- Keywords
- Virtual reality, Preoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Patients will use virtual reality before the procedure in addition to usual preoperative care.
| Study group | Role | What they receive |
|---|---|---|
| VR | Experimental | Patients will use virtual reality before the procedure in addition to usual preoperative care. Receives: Device: Virtual reality headset |
| NO VR | No intervention | Patients will not use virtual reality; hence, they will experience usual preoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (before VR), after 15 minutes, after 1 hour
Secondary outcomes (5)
Change of anxiety (VAS-A score)
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.
Measured: At baseline (before VR), after 15 minutes, after 1 hour
Change in heart rate
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).
Measured: At baseline (before VR), after 15 minutes, after 1 hour
Change in blood pressure
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.
Measured: At baseline (before VR), after 15 minutes, after 1 hour
Patient satisfaction on a scale from 0 to 10
0=totally unsatisfied 10= totally satisfied
Measured: After 1 hour
Operator satisfaction on a 0-10 scale
0 = totally unsatisfied with patient's compliance 10 = totally satisfied with patient's compliance
Measured: After 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giancarlo Facchini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745765
- Sponsor's protocol ID
- CE AVEC: 622/2024/Sper/IOR
- Acronym
- VR-IR
- Status last verified
- May 2026
- First submitted
- 12 Dec 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality in the Management of Anxiety in Patients Undergoing Interventional Radiology Procedures: Randomized Study
- ClinicalTrials.gov ID
- NCT06745765
- Acronym / sponsor ID
- VR-IR / CE AVEC: 622/2024/Sper/IOR
- Conditions
- Preoperative Anxiety
- Keywords
- Virtual reality, Preoperative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| VR | Experimental | Device: Virtual reality headsetPatients will use virtual reality before the procedure in addition to usual preoperative care. |
| NO VR | No intervention | –Patients will not use virtual reality; hence, they will experience usual preoperative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication to CT-guided biopsy in local anesthesia
- Informed consent signature
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetPatients will use virtual reality before the procedure in addition to usual preoperative care. | Device | VR |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Preoperative Anxiety, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Facchini, Medicine and Surgery (+39 0516366836, giancarlo.facchini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety change in STAI-S scale (time frame: At baseline (before VR), after 15 minutes, after 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.