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NCT06949462 | NOT YET RECRUITING | Consent Forms


Effectiveness of Large Language Model for Anaesthesia and Procedural Consent
Sponsor:

Singapore General Hospital

Information provided by (Responsible Party):

key U and

Brief Summary:

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.

Condition or disease

Consent Forms

Anesthesia

Artificial Intelligence (AI)

Intervention/treatment

PEAR

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
Masking Description : There will be no blinding of the participants and investigators due to the impracticality. The outcome assessor will be blinded.
Primary Purpose : OTHER
Official Title : Evaluating the Effectiveness of Large Language Models in Anaesthesia and Procedural Consent: A Comparative Analysis With Traditional Patient Consent Methods
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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)

Effectiveness of Large Language Model for Anaesthesia and Procedural Consent

Location Details

NCT06949462


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Locations


Not yet recruiting

Singapore,

Singapore General Hospital

Singapore, Singapore, 751126

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