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Virtual Reality for Anxiety in Interventional Radiology Procedures

ConditionPreoperative Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indication to CT-guided biopsy in local anesthesia

Informed consent signature

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality headset

    Device

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

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: VRExperimental treatment 1 intervention
Group B: NO VRNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

Time frame
At baseline (before VR), after 15 minutes, after 1 hour
2

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).

Time frame
At baseline (before VR), after 15 minutes, after 1 hour
3

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.

Time frame
At baseline (before VR), after 15 minutes, after 1 hour
4

Patient satisfaction on a scale from 0 to 10

0=totally unsatisfied 10= totally satisfied

Time frame
After 1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Ortopedico Rizzoli

Lead sponsor

Source ClinicalTrials.gov
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