Effects of Artificial Intelligence Nurse Orientation Program on Psychological Outcomes and Length of Hospital Stay in Intensive Care Unit

NCT07171944 | Not Yet Recruiting

• 1 other identifier: 2025.258.IRB2.124
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Artificial intelligence (AI), now an integral part of healthcare services and presents numerous opportunities. Customized treatment plans, clinical decision support systems, predictive analysis for disease prevention, patient engagement and education, quality improvement, and error reduction are some of these opportunities. In the context of delirium prevention, risk assessment, and treatment planning, the AI-supported system AI-AntiDelirium is designed to standardize the approach to delirium management in alignment with the PADIS guidelines. A randomized controlled trial evaluating the effectiveness of this system found that the workload of nurses decreased, facilitated early diagnosis and prevention of delirium, and recommended evidence-based and individualized delirium interventions. A systematic review concluded that AI applications did not significantly impact the length of hospital stay and emphasized the need for further research. Also, AI platforms contributed to positive results in reducing anxiety and depression in patients. Furthermore, systematic reviews have demonstrated that AI-based chatbots are effective in alleviating symptoms of depression and anxiety. However, the literature includes a limited number of patient education programs specifically designed to prevent or manage delirium through AI-based approaches. Notably, there is a lack of studies comparing the effectiveness of AI-supported educational interventions with those delivered directly by nurses. The goal of this clinical trial is to develop a structured AINurse and Human Nurse orientation training program for intensive care unit (ICU) patients and compare the effects of these training programs on ICU patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. Hypotheses of the study: H1: Patients who receive the structured AINurse patient orientation training program will have longer delirium-free days than patients who receive Human Nurse orientation training. H2: Patients who receive the structured AINurse patient orientation training program will have lower levels of anxiety and depression than patients who receive the Human Nurse orientation training. H3: Patients who receive the structured AINurse patient orientation training program will have shorter lengths of stay in the intensive care unit than patients who receive the Human Nurse orientation training. Researchers will compare the AINurse patient orientation training program and the orientation training program provided by human nurses in terms of patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU.

• Those in the intervention group will receive the AINurse orientation training program twice daily for 3 days.
• Participants in the control group will receive face-to-face structured orientation training from researchers twice daily for 3 days.
• Delirium-free day assessment, anxiety and depression will be evaluated for patients in both groups over 3 days.
• The length of stay in the intensive care unit will be monitored for patients in both groups.

Conditions

Delirium; Anxiety and Depression; Intensive Care Units (ICUs); Artificial Intelligence (AI); Nurse; Critical Care; Orientation

Keywords

Delirium; Artificial intelligence; Anxiety and depression; Intensive care unit; critical care; Orientation Training; Nurse

Outcome Measures

Primary Outcomes (1)

• Delirium-free days

  The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale will be used to assess delirium-free days. CAM-ICU is utilized to assess the presence of delirium in critically ill patients. The CAM-ICU evaluates four key features in critically ill patients: (1) acute onset or fluctuating course of mental status, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking. A positive diagnosis of delirium is made when the first two criteria are present, along with either the third or fourth. The scale yields a total score ranging from 0 to 7, with interpretive cut-off points as follows: 0-2 indicating no delirium, 3-5 suggesting mild to moderate delirium, and 6-7 indicating severe delirium.

  Before randomization, patients will be screened for delirium before being selected for the study.Patients scoring between 0 and 2 points will be included in the study. Subsequently, patients will be monitored for 3 days, with delirium assessed twice day.

Secondary Outcomes (2)

• Level of anxiety and depression

  It will be evaluated before and after the training for three days.

• Length of stay in the intensive care unit

  From the date of first randomization until discharge from the ICU , assessed up to 60 days or date of death from any cause (whichever came first)

Study Arms (2)

Artificial Intelligence Nurse (AINurse)

EXPERIMENTAL

The AI-Nurse orientation program to be implemented in the intervention group will be developed by a researcher who is part of the research team and has expertise in AI and engineering. During the development phase, the content of the program will be structured by researchers to be compatible with individual patient information. Voice-based orientation training will be provided using Google Cloud Text-to-Speech (TTS) API, which converts written text into natural-sounding speech. The training program will include approximately 10 minutes of audio narration and will be administered twice daily over a period of three days. The TTS engine allows for customization of voice parameters, including gender (female and male), speech tempo (slowed), and tone (calm). The AI Nurse system will be developed to work via mobile devices (e.g., an Android tablet). The patient will listen to the audio training through headphones and, if necessary, will be able to read the text on the screen.

Behavioral: Structured orientation program

Human Nurse

ACTIVE COMPARATOR

In this arm, participants will receive a structured orientation training program designed by the researcher, consisting of 10-minute sessions over three days at similar times and frequencies. This structured orientation training will be delivered face-to-face by the Human-Nurse researcher. Patients in this group will also be monitored for signs and symptoms of delirium over three days. The content of this training program will be developed by the researchers and subsequently reviewed by experts.

Behavioral: Human Nurse

Interventions

Structured orientation program BEHAVIORAL

Artificial intelligence technology will be incorporated into the orientation training program developed for patients in the intensive care unit who are assigned to the intervention group. The program will be administered twice daily over a three-day period. In this group, delirium-free days will be tracked, changes in anxiety and depression levels will be evaluated, and the length of intensive care unit stay among patients who remain free of delirium through this intervention will be examined.

Artificial Intelligence Nurse (AINurse)

Human Nurse BEHAVIORAL

Researchers will administer a structured orientation training program lasting approximately 10 minutes face-to-face to participants in the control group. This training program will be administered twice daily for 3 days. Following the training program, delirium-free days, anxiety and depression scores, and length of stay in the intensive care unit will be evaluated.

Human Nurse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive care unit confusion assessment scale (CAM-ICU scale) score of 0-2
• Age 18 years or older
• Hospitalized in the intensive care unit for at least 24 hours
• Glasgow coma scale score of 13-14-15 points
• Richmond Agitation Sedation Scale (RASS) score between -1 and +1
• No hearing problems

You may not qualify if:

• Intensive care unit confusion assessment scale (CAM-ICU scale) score of 6-7
• Any psychiatric illness or impaired brain function
• Defined hearing loss
• Advanced dementia
• Younger than 18 years of age
• Richmond Agitation Sedation Scale (RASS) score outside the range of -1 to +1
• Who use sedative medication
• History of surgery or disease around the ear

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (4)

• Sadeh-Sharvit S, Camp TD, Horton SE, Hefner JD, Berry JM, Grossman E, Hollon SD. Effects of an Artificial Intelligence Platform for Behavioral Interventions on Depression and Anxiety Symptoms: Randomized Clinical Trial. J Med Internet Res. 2023 Jul 10;25:e46781. doi: 10.2196/46781.

  PMID: 37428547 RESULT

• Zhang S, Ding S, Cui W, Li X, Wei J, Wu Y. Evaluating the effectiveness of a clinical decision support system (AI-Antidelirium) to improve Nurses' adherence to delirium guidelines in the intensive care unit. Intensive Crit Care Nurs. 2025 Apr;87:103933. doi: 10.1016/j.iccn.2024.103933. Epub 2025 Jan 8.

  PMID: 39787945 RESULT

• Khalifa, M., Albadawy, M., & Iqbal, U. (2024). Advancing clinical decision support: The role of artificial intelligence across six domains. Computer Methods and Programs in Biomedicine Update, 5, 100142. Doi: doi.org/10.1016/j.cmpbup.2024.100142

  RESULT

• Wubineh BZ, Deriba FG, Woldeyohannis MM. Exploring the opportunities and challenges of implementing artificial intelligence in healthcare: A systematic literature review. Urol Oncol. 2024 Mar;42(3):48-56. doi: 10.1016/j.urolonc.2023.11.019. Epub 2023 Dec 14.

  PMID: 38101991 RESULT

MeSH Terms

Conditions

Delirium; Anxiety Disorders; Depression; Orientation, Spatial

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Spatial Behavior

Study Officials

• Pelin Karaçay, Associate Professor

  Koç University

  STUDY DIRECTOR

Central Study Contacts

Pelin Karaçay, Associate Professor

CONTACT

+90 05325475674; pkaracay@ku.edu.tr

Elif Aylin Basüt, RN,BSN

CONTACT

+90 5346793555; edagli17@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In the experimental group, the structured AI-Nurse orientation program will be listened to twice daily (10:00 and 14:00) through a headset connected to a structured audio recording application. The content will include orientation to time and environment but will exclude any personally identifiable information such as the patient's name. Following each orientation session, the daily news will be played with the help of the television in the patient's room (at 10:30-14:30), aiming to enhance environmental awareness and perception of real-time audio streaming. In the control group, the structured orientation training will be given face-to-face by the Human-Nurse researcher. The patient in this group will also be monitored for signs and symptoms of delirium for three days.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)