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

August 16, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 55 years or older.
  2. Admitted to the emergency intensive care unit within the previous 24 hours.
  3. 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.
  4. Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥14.
  5. Sufficiently alert to communicate, with a Glasgow Coma Scale score of E4V4-5M6 or E4VTM6.
  6. Diagnosed with an infection or an infection-related critical illness, such as sepsis, urinary tract infection, or pneumonia.

Exclusion Criteria:

  1. Diagnosed visual or hearing impairment that would interfere with receiving the audiovisual intervention.
  2. History of substance abuse.
  3. History of psychiatric illness.
  4. Moribund status, receipt of a palliative care consultation, or an expected survival of 7 days or less.
  5. Unable to communicate in Mandarin Chinese or Taiwanese Hokkien.
  6. No family caregiver available to participate in preparation of the audiovisual intervention.
  7. History of surgery within the previous 7 days.
  8. Montreal Cognitive Assessment (MoCA) score <23.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Intelligent Audiovisual Intervention
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Delirium Assessed Using the CAM-ICU-7
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Richmond Agitation-Sedation Scale Score
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 16, 2026

First Submitted That Met QC Criteria

August 16, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 16, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-08-007BC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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