Exploring the Effectiveness of Intelligent Audiovisual Interventions in Delirium, Agitation, and Pain Among Middle Aged and Elderly Patients in Emergency Intensive Care Units: A Quasi-Experimental Study
16. august 2026 oppdatert av: Taipei Veterans General Hospital, Taiwan
The goal of this nonrandomized, quasi-experimental clinical trial is to evaluate whether an intelligent audiovisual intervention can prevent delirium and reduce delirium severity, agitation, and pain among adults aged 55 years or older admitted to an emergency intensive care unit (EICU). The main questions it aims to answer are:
Does the intelligent audiovisual intervention reduce the incidence and severity of delirium compared with routine care? Does the intervention improve agitation and pain scores compared with routine care?
Researchers will compare participants receiving the intelligent audiovisual intervention plus routine care with participants receiving routine care alone. Participants will be assigned according to the week of EICU admission: those admitted during odd-numbered weeks will receive the intervention, while those admitted during even-numbered weeks will receive routine care.
Participants in the intervention group will:
View a structured audiovisual program containing a prerecorded message from a family member, current date and weather information, and images of the area surrounding the hospital.
Receive the intervention for 2 minutes per session, 3 times daily for 2 consecutive days, beginning within 24 hours after EICU admission.
Participants in both groups will undergo assessments of delirium, agitation, and pain 3 times daily for 2 consecutive days. Delirium incidence and severity will be assessed using the Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7). Agitation will be evaluated using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using either the Numerical Rating Scale (NRS) or the Face, Legs, Activity, Cry, and Consolability (FLACC) scale.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
128
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Li Fang-Yu
- Telefonnummer: +886 966-914-515
- E-post: fylee6@vghtpe.gov.tw
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:
- Aged 55 years or older.
- Admitted to the emergency intensive care unit within the previous 24 hours.
- No delirium at baseline, defined as a negative Confusion Assessment Method for the Intensive Care Unit assessment and a CAM-ICU-7 score of 0-2.
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥14.
- Sufficiently alert to communicate, with a Glasgow Coma Scale score of E4V4-5M6 or E4VTM6.
- Diagnosed with an infection or an infection-related critical illness, such as sepsis, urinary tract infection, or pneumonia.
Exclusion Criteria:
- Diagnosed visual or hearing impairment that would interfere with receiving the audiovisual intervention.
- History of substance abuse.
- History of psychiatric illness.
- Moribund status, receipt of a palliative care consultation, or an expected survival of 7 days or less.
- Unable to communicate in Mandarin Chinese or Taiwanese Hokkien.
- No family caregiver available to participate in preparation of the audiovisual intervention.
- History of surgery within the previous 7 days.
- Montreal Cognitive Assessment (MoCA) score <23.
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: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intelligent Audiovisual Intervention
Participants will receive routine care plus a structured intelligent audiovisual intervention beginning within 24 hours after admission to the emergency intensive care unit.
The audiovisual program includes a prerecorded message from a family member, current date and weather information, and images of the area surrounding the hospital to provide cognitive orientation cues and emotional support.
The intervention will be delivered for 2 minutes per session, 3 times daily (at 7:00 AM, 5:00 PM, and 9:00 PM) for 2 consecutive days.
Participants will also receive routine family visiting twice daily.
|
A structured, personalized audiovisual intervention designed to provide cognitive reorientation and emotional support.
The program incorporates person, time, and place orientation cues, including a prerecorded message from a family member using the participant's name and familiar language; current date, weather, and temperature information presented through automated audiovisual content; and images of the area surrounding the hospital.
Participants will receive the intervention for 2 minutes per session, 3 times daily (at 7:00 AM, 5:00 PM, and 9:00 PM) for 2 consecutive days, beginning within 24 hours after admission to the emergency intensive care unit.
The intervention will be provided in addition to routine care.
|
|
Ingen inngripen: Routine Care
Participants will receive routine care without the intelligent audiovisual intervention.
Routine care includes standard medical and nursing care and family visiting twice daily, at 11:00 AM and 7:00 PM, for 1 hour per visit.
Participants will undergo the same assessments of delirium, agitation, and pain as those in the experimental arm.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Delirium Assessed Using the CAM-ICU-7
Tidsramme: From baseline through the end of Day 2; assessed 3 times daily
|
Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7).
The outcome will be reported as the percentage of participants with at least one positive CAM-ICU-7 assessment during the 2-day assessment period.
|
From baseline through the end of Day 2; assessed 3 times daily
|
|
Change From Baseline in Delirium Severity Assessed Using the CAM-ICU-7
Tidsramme: Baseline through the end of Day 2; assessed 3 times daily
|
Delirium severity will be measured using the CAM-ICU-7.
Total scores range from 0 to 7, with higher scores indicating greater delirium severity.
Scores of 0 to 2 indicate no delirium, 3 to 5 indicate mild to moderate delirium, and 6 to 7 indicate severe delirium.
Changes from baseline will be evaluated across the scheduled assessments.
|
Baseline through the end of Day 2; assessed 3 times daily
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Richmond Agitation-Sedation Scale Score
Tidsramme: Baseline through the end of Day 2; assessed 3 times daily
|
Agitation and sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS).
Scores range from -5 to +4.
A score of 0 indicates that the participant is alert and calm, positive scores indicate increasing agitation, and negative scores indicate increasing levels of sedation.
|
Baseline through the end of Day 2; assessed 3 times daily
|
|
Change From Baseline in Pain Intensity Score
Tidsramme: Baseline through the end of Day 2; assessed 3 times daily
|
Pain intensity will be assessed using the 11-point Numerical Rating Scale (NRS) for participants able to self-report or the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for participants unable to communicate reliably.
Both scales range from 0 to 10, with higher scores indicating greater pain intensity.
|
Baseline through the end of Day 2; assessed 3 times daily
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.
- Waszynski CM, Milner KA, Staff I, Molony SL. Using simulated family presence to decrease agitation in older hospitalized delirious patients: A randomized controlled trial. Int J Nurs Stud. 2018 Jan;77:154-161. doi: 10.1016/j.ijnurstu.2017.09.018. Epub 2017 Oct 7.
- Ma Y, Zhang Y, Cui N, Guo Z, Jin J. The effects of structured family auditory stimulation on preventing ICU delirium among patients with unplanned admissions: A randomized controlled study. Intensive Crit Care Nurs. 2025 Aug;89:103944. doi: 10.1016/j.iccn.2025.103944. Epub 2025 Feb 5.
- Munro CL, Cairns P, Ji M, Calero K, Anderson WM, Liang Z. Delirium prevention in critically ill adults through an automated reorientation intervention - A pilot randomized controlled trial. Heart Lung. 2017 Jul-Aug;46(4):234-238. doi: 10.1016/j.hrtlng.2017.05.002. Epub 2017 Jun 9.
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. august 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
16. august 2026
Først innsendt som oppfylte QC-kriteriene
16. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-08-007BC
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared because the study involves critically ill patients and contains sensitive clinical information.
In addition, the personalized audiovisual materials may include family members' voices and contextual information that could increase the risk of participant identification.
Study data will be securely maintained and used only for the purposes approved by the institutional review board and described in the informed consent process.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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