Clinical Trial

Structured Communication About Artificial Intelligence in Perioperative Care (AI-COM)

Study acronym: AI-COM
Completed
View on ClinicalTrials.gov →
Summary
This study investigates whether structured communication about artificial intelligence (AI) in perioperative care can reduce preoperative anxiety and improve perceived control among adult patients undergoing elective surgery. As AI-supported tools become more common in healthcare, patients may feel uncertain about how these technologies relate to their care, whether they influence clinical decisions, and whether healthcare professionals remain responsible for final decision-making. Such uncertainty may contribute to anxiety before surgery and may reduce patients' sense of control. In this attention-controlled randomized trial, adult patients scheduled for elective surgery will be assigned to one of two groups. The attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. The intervention group will receive standard preoperative information plus a structured, non-technical communication protocol about AI in perioperative care. The protocol will explain the supportive role of AI, emphasize human clinical oversight, address AI-related uncertainty, and help patients understand that general information about AI must be interpreted in relation to their individual clinical situation. Preoperative anxiety, perceived control, AI-related uncertainty, information clarity, and trust in the clinical team will be assessed using structured questionnaires. The study does not test or evaluate any AI software, medical device, imaging system, or diagnostic technology. Instead, it focuses on whether structured communication about AI-related uncertainty can improve psychological preparedness before surgery. The findings may help inform practical, transparent, and patient-centered communication strategies for discussing AI-supported healthcare technologies in perioperative settings.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-03-25 -> 2026-04-25 2026-05-05
minor Completion pushed: 2026-03-25 -> 2026-04-25 2026-05-05
Trial Details
NCT Number NCT07393945
Lead Sponsor Agri Ibrahim Cecen University
Conditions Preoperative Anxiety, Perceived Control, AI-Related Uncertainty
Enrollment 120 participants
Start Date 2026-02-05
Primary Completion 2026-04-25 (estimated)
Study Completion 2026-04-25 (estimated)
Updated on ClinicalTrials.gov 2026-05-04