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

NCT07393945 | Completed

• 1 other identifier: AI-XAI-PA-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoperative Anxiety; Perceived Control; AI-Related Uncertainty

Keywords

Perioperative care; Patient communication; Perceived control; Artificial intelligence; eHealth literacy; Structured communication; Attention-controlled randomized trial

Outcome Measures

Primary Outcomes (1)

• Post-Communication Preoperative Anxiety

  Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscale. The primary outcome is the post-communication APAIS anxiety score measured before surgery, with baseline APAIS anxiety accounted for in the analysis. The APAIS anxiety subscale consists of 4 items scored on a 5-point Likert scale, with total scores ranging from 4 to 20. Higher scores indicate higher preoperative anxiety.

  Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.

Secondary Outcomes (1)

• Post-Communication Perceived Control

  Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.

Other Outcomes (2)

• Baseline eHealth Literacy

  Baseline before randomization.

• Post-Communication AI-Related Uncertainty

  Baseline before randomization.

Study Arms (2)

Structured AI Communication

EXPERIMENTAL

Participants in this arm will receive standard preoperative information plus a structured, non-technical communication protocol about artificial intelligence in perioperative care. The protocol is delivered face-to-face by a trained nurse and is designed to reduce AI-related uncertainty, improve information clarity, emphasize professional human oversight of AI-supported systems, and help patients understand how general information about AI relates to their individual clinical situation.

Behavioral: Structured Artificial Intelligence Communication

Attention-Control Supportive Communication

ACTIVE COMPARATOR

Participants in this arm will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. The session is similar in duration to the structured AI communication protocol and focuses on general preoperative support and routine patient questions. It does not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.

Other: Attention-Control Supportive Communication

Interventions

Structured Artificial Intelligence Communication BEHAVIORAL

A brief, approximately 5-7-minute, face-to-face structured communication protocol delivered by a trained nurse using clear, non-technical, patient-centered language. The protocol explains the supportive role of artificial intelligence in perioperative care, emphasizes that clinical decisions remain under professional human oversight, addresses AI-related uncertainty, contextualizes general AI-related information for the individual patient, and encourages patient questions. No AI software, medical device, imaging system, or diagnostic technology is used, tested, or evaluated as part of this intervention.

Structured AI Communication

Attention-Control Supportive Communication OTHER

A brief, approximately 5-7-minute, face-to-face general supportive nurse-patient communication session delivered in addition to standard preoperative information. The session is time-matched to the structured AI communication protocol and focuses on general preoperative support and routine patient questions. It does not include structured explanation of artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.

Attention-Control Supportive Communication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 65 years.
• Scheduled for elective surgical procedures.
• Able to communicate in Turkish.
• At least primary school literacy.
• Able and willing to provide written informed consent.
• Able to complete self-report questionnaires before surgery.

You may not qualify if:

• Emergency surgical procedures.
• Known diagnosis of psychiatric disorder.
• Current use of anxiolytic or antidepressant medications.
• Cognitive impairment or communication barriers that may interfere with study participation.
• American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
• Severe visual or hearing impairment that prevents participation in the communication session or completion of questionnaires.
• Previous participation in this study.

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

Ağrı Training and Research Hospital

Ağrı, Merkez, Turkey (Türkiye)

Location

Related Publications (4)

• Chan SL, Sit JWH, Ang WW, Lau Y. Virtual reality-enhanced interventions on preoperative anxiety symptoms in adults undergoing elective surgery: A meta-analysis and meta-regression. Int J Nurs Stud. 2024 Dec;160:104886. doi: 10.1016/j.ijnurstu.2024.104886. Epub 2024 Aug 30.

  PMID: 39270596 BACKGROUND

• Xu H, Hou J, Zhou J, Wang S. Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis. J Perianesth Nurs. 2025 Apr;40(2):422-430.e3. doi: 10.1016/j.jopan.2024.05.009. Epub 2024 Sep 26.

  PMID: 39340515 BACKGROUND

• Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22.

  PMID: 21943828 BACKGROUND

• Yahagi M, Hiruta R, Miyauchi C, Tanaka S, Taguchi A, Yaguchi Y. Comparison of Conventional Anesthesia Nurse Education and an Artificial Intelligence Chatbot (ChatGPT) Intervention on Preoperative Anxiety: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Oct;39(5):767-771. doi: 10.1016/j.jopan.2023.12.005. Epub 2024 Mar 21.

  PMID: 38520470 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention providers cannot be masked because of the communication-based nature of the intervention. Post-communication outcome questionnaires will be self-administered, and outcome data will be collected by research staff not involved in intervention delivery. Statistical analyses will be performed by an independent analyst blinded to group allocation, with groups coded before analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups. The intervention group will receive standard preoperative information plus a structured communication protocol about artificial intelligence in perioperative care. The attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session that does not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: February 5, 2026
• Primary Completion: April 25, 2026
• Study Completion: April 25, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)