Effectiveness of Large Language Model for Anaesthesia and Procedural Consent (PEAR)

Singapore Health Services (SingHealth)

Status: Not yet enrolling

Conditions: Consent Forms; Artificial Intelligence (AI); Anesthesia

Treatments: Other: PEAR

Study type: Interventional

Funder types: Other

Identifiers

NCT06949462

2025-04-22

Details and patient eligibility

About

Patient understanding of anaesthesia risks remains inconsistent due to time constraints, language barriers, and variable clinician communication styles. Traditional verbal consent may not consistently ensure comprehension or reduce preoperative anxiety. PEAR (Patient Education of Anesthesia Risks) is a multilingual, AI-driven chatbot developed to enhance patient education and improve the quality of anaesthesia risk counselling.

Study Objective:

To compare PEAR's performance in delivering anaesthesia risk consent against the standard face-to-face verbal method.

Full description

This study evaluates the effectiveness of PEAR (Patient Education of Anaesthesia Risks), a conversational AI-based chatbot designed to deliver anaesthesia risk education to patients in a personalized, interactive, and multilingual format. The goal is to support informed consent by improving patient comprehension, satisfaction, and reducing anxiety, while also streamlining clinician workflow.

Participants undergoing elective surgery will be randomly assigned to either receive anaesthesia counselling via PEAR before their consultation with the anaesthetist (intervention group) or undergo the standard face-to-face verbal consent process (control group). The PEAR chatbot is accessed through a secure digital interface and presents information aligned with institutional anaesthesia protocols.

The study will be conducted at hospitals within the SingHealth cluster in Singapore. Following the consent process, patients will complete a short quiz to assess understanding, a survey to evaluate satisfaction, and an anxiety scale. Clinicians will record time taken and perceived workload.

All patients will still meet their anaesthetist, ensuring clinical oversight is maintained. This study does not alter standard care but evaluates a digital adjunct to enhance it. Data will be collected electronically, anonymised, and stored securely. Insights from this trial may inform the wider implementation of digital tools in perioperative patient education.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (≥21 years old) undergoing elective surgery requiring anaesthesia

Classified as ASA Physical Status I to III

• Able to provide informed consent
• Able to communicate effectively in English, Chinese (Mandarin), Malay, or Tamil
• Willing and able to complete questionnaires and interact with the PEAR chatbot (intervention arm)

Exclusion criteria

• ASA Physical Status IV or above
• Cognitive impairment or psychiatric conditions that may limit comprehension or communication
• Non-literate patients or those unable to understand English, Chinese, Malay, or Tamil
• Emergency surgery cases
• Prior participation in the study (to prevent bias)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in the control arm will receive the standard anaesthesia risk counselling conducted face-to-face by a licensed anaesthetist. This process follows institutional protocols and includes a verbal explanation of anaesthesia procedures, associated risks, benefits, and potential complications, tailored to the patient's specific surgical context. Patients are encouraged to ask questions and engage in discussion during the session. No digital tools or chatbot assistance will be used in this arm.

PEAR

Experimental group

Description:

Participants in this arm will receive anaesthesia risk counselling through the PEAR (Patient Education of Anaesthesia Risks) chatbot, a multilingual, AI-powered conversational tool. The chatbot provides personalized education on anaesthesia risks, procedures, and post-operative expectations. Patients interact with the chatbot prior to meeting the anaesthetist, enhancing their understanding and preparing them for the face-to-face consultation.

Treatment:

Other: PEAR