NCT07393945

Perioperative Human-Centered Communication to Reduce Patient-Facing Uncertainty

Effects of Human-Centered Communication Targeting Patient-Facing Uncertainty on Preoperative Anxiety and Perceived Control: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Agri Ibrahim Cecen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigates whether a structured, human-centered communication intervention designed to reduce patient-facing uncertainty can decrease preoperative anxiety and improve perceived control among patients undergoing elective surgery. Modern healthcare environments are increasingly complex, and patients are often exposed to medical processes and information that may be difficult to interpret. Such uncertainty-arising from clinical procedures, decision-making processes, and externally obtained health information-may contribute to increased anxiety before surgery. However, communication strategies specifically targeting this uncertainty remain underexplored. In this randomized controlled trial, adult patients scheduled for elective surgery will be assigned to one of two groups. The control group will receive standard preoperative information routinely provided by the hospital. The intervention group will receive standard information plus a brief, structured, and non-technical communication intervention aimed at improving clarity, contextualization, and understanding of the care process. The intervention emphasizes the role and limitations of clinical systems, the presence of human oversight in decision-making, and the importance of individualized medical context when interpreting general health information. Preoperative anxiety and perceived control will be assessed before and after the intervention using validated questionnaires. The study does not involve the testing or evaluation of any medical technology or system, but rather focuses on how communication addressing uncertainty influences patients' psychological preparedness for surgery. The findings may inform the development of scalable, human-centered communication strategies to improve patient experience and psychological outcomes in perioperative care.

Detailed description

The increasing integration of artificial intelligence (AI)-supported real-time imaging systems into clinical workflows has transformed diagnostic and perioperative practices. While the technical performance and clinical utility of these systems have been widely studied, considerably less attention has been given to how patients perceive and psychologically respond to information about AI-supported technologies used in their care. Preoperative anxiety is a common psychological stressor among surgical patients and is associated with adverse perioperative outcomes, including increased postoperative pain, delayed recovery, and reduced patient satisfaction. Perceived control has been identified as a key psychological factor that can buffer the negative effects of anxiety, particularly in high-uncertainty clinical contexts such as the perioperative period. This single-center, parallel-group randomized controlled trial is designed to evaluate the psychological effects of a structured, human-centered communication intervention related to AI-supported real-time imaging systems. Adult patients scheduled for elective surgery will be randomly assigned in a 1:1 ratio to either an intervention group or a control group following baseline assessment. Participants in the control group will receive standard preoperative information routinely provided by the institution. Participants in the intervention group will receive standard information plus a brief (approximately 5-7 minutes), face-to-face, structured explanation about AI-supported real-time imaging systems. The intervention will use non-technical, patient-centered language and will address the general purpose of such systems, their role and limitations in clinical practice, and their relationship to patient safety and clinical decision-making. The intervention does not involve the use, testing, or evaluation of any specific AI software, device, or imaging system. Preoperative anxiety and perceived control will be assessed at baseline (prior to randomization) and again after the information session, before surgery. The primary analyses will compare changes in anxiety and perceived control between the intervention and control groups, with baseline values accounted for in the statistical models. This study does not aim to assess the diagnostic accuracy, technical performance, or clinical effectiveness of AI-supported imaging systems. Instead, it focuses on the communication and explanatory context surrounding such technologies, with the goal of informing human-centered, transparent, and ethically responsible strategies for integrating AI-supported systems into perioperative care.

Conditions

• Preoperative Anxiety
• Perceived Control

Interventions

Type	Name	Description
BEHAVIORAL	Human-Centered Explainable AI Communication	A brief (approximately 5-7 minutes), face-to-face, structured communication delivered by a nurse, providing a non-technical and patient-centered explanation of AI-supported real-time imaging systems, including their general purpose, limitations, and relationship to patient safety. No AI software, device, or imaging system is tested or evaluated as part of the intervention.
OTHER	Standard Preoperative Information	Routine preoperative information provided by the institution as part of standard clinical care.

Timeline

• Start date: 2026-02-05
• Primary completion: 2026-03-25
• Completion: 2026-03-25
• First posted: 2026-02-06
• Last updated: 2026-04-17

Locations

1 site across 1 country: Turkey (Türkiye)