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A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)

25. juni 2026 oppdatert av: University Hospital, Clermont-Ferrand

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
Enhet: Immersive 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.
Andre navn:
  • HypnoVR
Ingen inngripen: Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Procedural Anxiety and Procedural Pain
Tidsramme: 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.
From immediately before the procedure to immediately after the procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Satisfaction
Tidsramme: Immediately after the procedure
Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
Immediately after the procedure
Operator Experience
Tidsramme: Immediately after the procedure
Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
Immediately after the procedure
Procedure Duration
Tidsramme: During the procedure
Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
During the procedure
Analgesic Use During the Procedure
Tidsramme: During the procedure
Use and type of analgesic medications administered during the procedure.
During the procedure
Feasibility of Immersive Virtual Reality Use
Tidsramme: 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.
During and immediately after the procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Clermont-Ferrand

Etterforskere

  • Hovedetterforsker: Pascal Chabrot, University Hospital, Clermont-Ferrand

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

19. juni 2026

Først innsendt som oppfylte QC-kriteriene

19. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RBHP 2025 CHABROT

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