A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Lise Laclautre
- Puhelinnumero: 0473754963
- Sähköposti: promo_interne_drci@chu-clermontferrand.fr
Opiskelupaikat
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-
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Clermont-Ferrand, Ranska
- CHU clermont-ferrand
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Päätutkija:
- Pascal Chabrot
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Ottaa yhteyttä:
- Lise Laclautre
- Puhelinnumero: 0473754963
- Sähköposti: promo_interne_drci@chu-clermontferrand.fr
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
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Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
Muut nimet:
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Ei väliintuloa: Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Procedural Anxiety and Procedural Pain
Aikaikkuna: From immediately before the procedure to immediately after the procedure
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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.
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From immediately before the procedure to immediately after the procedure
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Patient Satisfaction
Aikaikkuna: Immediately after the procedure
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Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Operator Experience
Aikaikkuna: Immediately after the procedure
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Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Procedure Duration
Aikaikkuna: During the procedure
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Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
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During the procedure
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Analgesic Use During the Procedure
Aikaikkuna: During the procedure
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Use and type of analgesic medications administered during the procedure.
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During the procedure
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Feasibility of Immersive Virtual Reality Use
Aikaikkuna: During and immediately after the procedure
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Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use.
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During and immediately after the procedure
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Pascal Chabrot, University Hospital, Clermont-Ferrand
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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