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Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units

3 settembre 2026 aggiornato da: Liang Surui, Chinese University of Hong Kong

Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. The main questions it aims to answer are:

  1. Does VR-based sensory stimulation delay the time to the first delirium event during ICU stay?
  2. Does VR-based sensory stimulation reduce delirium incidence, duration, and severity?
  3. What are the effects of the intervention on ICU length of stay, duration of mechanical ventilation, cognitive function at 3 months after ICU discharge, and health-related quality of life? Researchers will compare immersive VR-based sensory stimulation with a non-immersive tablet-based active control to assess the added value of immersion beyond the effects of sensory content alone.

Participants will:

  1. Receive either immersive VR-based sensory stimulation or tablet-based sensory stimulation
  2. Receive one 20-minute session per day for up to 3 days during ICU stay Undergo twice-daily delirium assessments during ICU stay Complete follow-up assessments of cognitive function and health-related quality of life at 3 months after ICU discharge

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Delirium is a common acute neurocognitive disorder in critically ill patients and is associated with poor short- and long-term outcomes, including prolonged ICU stay, extended mechanical ventilation, persistent cognitive impairment, and reduced quality of life after discharge. Environmental factors in the ICU, particularly sensory deprivation and excessive noise and light disturbance, are recognized as modifiable contributors to delirium risk.

Conventional sensory stimulation has shown potential to delay delirium onset and reduce delirium severity in ICU patients. However, implementation in routine ICU practice is challenging because intervention delivery may be disrupted by the complex ICU environment and may vary across clinical staff and settings.

This study evaluates a virtual reality (VR)-based sensory stimulation intervention designed to provide immersive visual and auditory input while reducing interference from the ICU environment. The intervention uses a head-mounted display and headphones to deliver standardized nature-based content. An active control condition was selected to receive the same content through a tablet, allowing comparison of immersive versus non-immersive delivery while controlling for the sensory content itself.

This study is a pilot randomized controlled trial conducted in adult ICU patients. Participants are randomly assigned in a 1:1 ratio to either the VR intervention group or the active control group. Both groups receive one 20-minute session daily for up to 3 days during ICU stay. Delirium is assessed twice daily during ICU stay, and participants are followed at 3 months after ICU discharge for cognitive and quality-of-life outcomes. The study is intended to generate preliminary estimates of intervention effects and to inform the design of a future definitive trial.

Tipo di studio

Interventistico

Iscrizione (Stimato)

300

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Guangdong
      • Shenzhen, Guangdong, Cina, 518133
        • Reclutamento
        • Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18 years or older
  • Admitted to the ICU
  • Undergoing or expected to require mechanical ventilation
  • Expected ICU stay of at least 48 hours
  • Awake or lightly sedated, defined as a Richmond Agitation-Sedation Scale - (RASS) score between -1 and +1
  • Able to understand and follow instructions
  • Provided informed consent [or surrogate consent, if applicable]

Exclusion Criteria:

  • Pre-existing cognitive impairment or dementia
  • Acute psychiatric illness at admission
  • Delirium at enrollment as assessed by CAM-ICU
  • Terminal-stage cancer
  • APACHE II score > 20
  • Severe uncorrectable hearing or visual impairment
  • Traumatic brain injury or intracranial drainage tubes that make use of the VR headset impractical

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: immersive VR group
Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
Dispositivo: immersive VR group
Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
Comparatore attivo: active control group
Participants received the same nature-based audiovisual content delivered through a tablet-based non-immersive format. Sessions were delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
Comportamentale: Active control group
Participants received the same nature-based audiovisual content through a tablet in a non-immersive format for 20 minutes once daily for up to 3 days during ICU stay.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Delirium Event During ICU Stay
Lasso di tempo: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Time from study enrollment to the first episode of delirium detected by the Confusion Assessment Method for the ICU (CAM-ICU).
Every day, from ICU admission to ICU discharge, assessed up to 28 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Delirium Incidence
Lasso di tempo: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Proportion of participants who developed delirium during ICU stay as assessed by CAM-ICU.
Every day, from ICU admission to ICU discharge, assessed up to 28 days
Delirium Duration
Lasso di tempo: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Total number of days during which delirium was present during ICU stay.
Every day, from ICU admission to ICU discharge, assessed up to 28 days
ICU Length of Stay
Lasso di tempo: From date of ICU admission until the date of ICU discharge, assessed up to 28 days
Total number of days from ICU admission to ICU discharge.
From date of ICU admission until the date of ICU discharge, assessed up to 28 days
Duration of Mechanical Ventilation
Lasso di tempo: From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days
Total duration of mechanical ventilation during ICU stay.
From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days
Cognitive Function at 3 Months
Lasso di tempo: 3 months after ICU discharge
Cognitive function assessed by the telephone-based Montreal Cognitive Assessment (t-MoCA).
3 months after ICU discharge
Health-Related Quality of Life at 3 Months
Lasso di tempo: 3 months after ICU discharge
Health-related quality of life assessed by the EuroQol Five Dimensions Questionnaire (EQ-5D).
3 months after ICU discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chinese University of Hong Kong

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

14 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2026

Primo Inserito (Effettivo)

8 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NYSZYYEC20230074R003

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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