Effectiveness of Large Language Model for Anaesthesia and Procedural Consent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorSingapore General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PEAR
Other interventionParticipants in the intervention arm will receive anaesthesia risk counselling through the PEAR (Patient Education of Anaesthesia Risks) chatbot prior to their face-to-face consultation with an anaesthetist. PEAR is a multilingual, AI-powered conversational tool designed to provide personalized, interactive education on anaesthesia-related procedures, risks, and safety information. The chatbot delivers content aligned with institutional guidelines and allows patients to explore topics at their own pace, ask questions in natural language, and revisit information as needed. After completing the chatbot interaction, patients proceed with their standard preoperative consultation, where any further questions are addressed by the anaesthetist. This approach is designed to enhance patient understanding, reduce anxiety, and optimize the in-person consultation by preparing patients in advance.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: PEARExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient self-reported understanding of anaesthesia risks
The primary outcome was assessed using a Patient-Reported Experience Measure (PREM) focused on subjective comprehension of anesthesia. This was measured via three validated 5-point Likert scale items (1 = strongly disagree, 5 = strongly agree) evaluating: (1) clarity of risks and procedures, (2) confidence in the anesthesia plan, and (3) self-reported ability to recall and explain key risks. While both groups completed these items following the clinician consultation, the intervention group underwent additional longitudinal assessments-at baseline and post-chatbot interaction-to facilitate a within-group analysis of the chatbot's independent educational impact.
Time frame
Immediately post-interaction with the PEAR ChatbotSecondary outcomes
1
Perceived Usefulness
Description: Evaluation of the user's subjective belief that using the PEAR chatbot enhanced their clinical experience. Measured using the mean score of three items: "The chatbot improved my understanding," "It was a useful addition to my consultation," and "It helped me make informed decisions." Unit of Measure: 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Time Frame: Immediately pre-consent and immediately post-consent (within the same clinic visit).
Time frame
Immediately pre-consent and post-consent (within the same clinic visit)2
Cost effectiveness
Participants were presented with a hypothetical choice scenario outlining explicit trade-offs between in-person clinic attendance (travel time 60-120 minutes, waiting time 60-180 minutes, travel cost $10-50 Singapore dollars, includes physical examination) versus chatbot use at home (zero travel time, zero waiting time, zero cost, no physical examination). Participants selected their preference, providing insight into patient values and priorities.
Time frame
Immediately post-chatbot use (same clinic visit)3
Perceived Ease of Use (PEOU)
Description: Evaluation of the degree to which the user believes that using the chatbot was free of effort. Measured using the mean score of four items: "Easy to use," "Easy to learn," "Comfortable navigating," and "Language was easy to understand." Unit of Measure: 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
Time frame
Immediately pre-consent and immediately post-consent (within the same clinic visit).4
Attitude Toward Using (ATT)
Description: Evaluation of the user's positive or negative feelings about performing the target behavior. Measured using the mean score of three items: "I enjoyed using the chatbot," "Using the chatbot was a good idea," and "I feel confident after using it." Unit of Measure: 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
Time frame
Immediately pre-consent and immediately post-consent (within the same clinic visit).Sponsors and contacts
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Source ClinicalTrials.gov