Anxiety, Pain, Radiology, Interventional
Conditions
Keywords
Virtual Reality, Interventional Radiology, State-Trait Anxiety Inventory, Patient Satisfaction, Non-pharmacological Intervention, Immersive Virtual Reality, Procedural Anxiety, Procedural Pain
Brief summary
Patients undergoing interventional radiology procedures frequently experience significant anxiety and procedural pain despite standard care. Virtual reality (VR) has emerged as a promising non-pharmacological tool for anxiety and pain reduction in various medical settings. The HYPNO-VR study is a prospective randomized controlled trial designed to evaluate the effect of immersive virtual reality during interventional radiology procedures. Participants will be randomized in a 1:1 ratio to either a virtual reality group or a standard care control group. The primary objective is to assess the impact of VR on procedural anxiety and pain using validated anxiety questionnaires (State-Trait Anxiety Inventory, STAI) and a numerical pain rating scale. Secondary and exploratory objectives include assessment of patient satisfaction, operator experience, procedural duration, analgesic use, and feasibility of VR integration in interventional radiology practice.
Detailed description
Interventional radiology procedures are frequently associated with significant procedural anxiety and pain, which may negatively affect patient experience, cooperation during the procedure, and overall procedural conditions. Although pharmacological analgesia and anxiolysis are commonly used, non-pharmacological approaches aimed at improving patient comfort are increasingly being explored. Immersive virtual reality (VR) has demonstrated promising effects on anxiety and pain reduction in several medical and surgical settings. By providing immersive audiovisual stimulation and distraction, VR may reduce the emotional and sensory perception associated with stressful medical procedures. However, data regarding its use in interventional radiology remain limited. The HYPNO-VR study is a prospective randomized controlled monocentric study evaluating the impact of immersive virtual reality during interventional radiology procedures performed under local anesthesia. Eligible adult patients undergoing an interventional radiology procedure will be randomized in a 1:1 ratio to either : * a virtual reality group receiving immersive VR during the procedure in addition to standard care ; * or a control group receiving standard care alone. The primary objective is to evaluate the effect of VR on procedural anxiety and pain. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-Y), including trait anxiety assessment before the procedure and state anxiety assessment immediately before and after the procedure. Procedural pain will be evaluated using a numerical rating scale. Secondary and exploratory objectives include evaluation of patient satisfaction, operator experience, procedural duration, analgesic use during the procedure, and feasibility of VR integration into routine interventional radiology practice. The study aims to assess whether immersive VR may represent a simple, feasible, and effective complementary tool to improve patient experience during interventional radiology procedures.
Interventions
DEVICEImmersive Virtual Reality
Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the intervention, blinding of participants and investigators is not feasible, as the use of the immersive virtual reality headset is directly visible during the procedure.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either an immersive virtual reality group receiving virtual reality during the interventional radiology procedure in addition to standard care, or to a control group receiving standard care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Age ≥18 years. * Scheduled to undergo an interventional radiology procedure performed under local anesthesia without sedation. * Affiliation to a health insurance system. * Received complete information about the study and provided written informed consent. * Ability to understand the study information and complete the questionnaires.
Exclusion criteria
: * Refusal to participate or withdrawal of consent. * Patients under legal protection preventing valid informed consent according to regulatory requirements. * Inability to understand study-related information or to use the virtual reality device due to severe visual, auditory, or cognitive impairment, as clinically assessed by the investigator. * History of photosensitive epilepsy or uncontrolled epilepsy, constituting a contraindication to virtual reality use. * Known contraindication to virtual reality use (history of severe cybersickness).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Procedural Anxiety and Procedural Pain | From immediately before the procedure to immediately after the procedure | Evaluation of procedural anxiety using the State-Trait Anxiety Inventory State scale (STAI-Y1) before and after the procedure. STAI-Y1 scores range from 20 to 80, with higher scores indicating greater anxiety. Procedural pain is assessed immediately after the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Immediately after the procedure | Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure. |
| Operator Experience | Immediately after the procedure | Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure. |
| Procedure Duration | During the procedure | Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention. |
| Analgesic Use During the Procedure | During the procedure | Use and type of analgesic medications administered during the procedure. |
| Feasibility of Immersive Virtual Reality Use | During and immediately after the procedure | Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use. |
Countries
France
Contacts
CONTACTLise Laclautre
PRINCIPAL_INVESTIGATORPascal Chabrot
University Hospital, Clermont-Ferrand
Outcome results
None listed