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

April 28, 2026 updated by: Volkan Gokmen, Agri Ibrahim Cecen University

Effects of Structured Communication About Artificial Intelligence in Perioperative Care on Preoperative Anxiety and Perceived Control: An Attention-Controlled Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Artificial intelligence (AI)-supported tools are increasingly discussed and implemented across healthcare, including perioperative care. Although the technical performance and clinical applications of AI systems have been widely studied, less attention has been given to how patients understand and psychologically respond to information about AI-supported healthcare technologies. Patients may be uncertain about the role of AI, whether it replaces or supports clinical judgment, how human oversight is maintained, and how general information about AI applies to their own care.

Preoperative anxiety is common among surgical patients and may be influenced by uncertainty, limited understanding of care processes, and difficulty interpreting health-related information. Perceived control may help patients cope with uncertainty by improving their ability to understand what is happening, how care decisions are guided, and how general information relates to their individual clinical context. Structured communication may therefore be a feasible strategy to reduce AI-related uncertainty, improve perceived control, and support psychological preparedness before surgery.

This single-center, two-arm, attention-controlled randomized trial will evaluate the effects of structured communication about AI in perioperative care on preoperative anxiety and perceived control among adult patients scheduled for elective surgery. A total of 120 participants will be randomized in a 1:1 ratio to either an attention-control group or an intervention group.

Participants in the attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. This session will be similar in duration to the intervention session and will focus on general preoperative support and routine patient questions. It will not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.

Participants in the intervention group will receive standard preoperative information plus a structured AI communication protocol delivered face-to-face by a trained nurse. The protocol will use clear, non-technical, patient-centered language and will explain the supportive role of AI in healthcare, emphasize that clinical decisions remain under professional human oversight, address uncertainty related to AI-supported technologies, contextualize general AI-related information for the individual patient, and encourage patient questions.

The intervention does not involve the use, testing, or evaluation of any AI software, medical device, imaging system, or diagnostic technology. The study does not assess the diagnostic accuracy, technical performance, or clinical effectiveness of AI-supported systems. Instead, it evaluates the psychological and communication-related effects of structured explanation about AI in perioperative care.

Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale. Perceived control, AI-related uncertainty, information clarity, trust in the clinical team, and baseline eHealth literacy will also be assessed using structured questionnaires. Outcomes will be measured at baseline before randomization and after the communication session before surgery. Statistical analyses will compare post-communication outcomes between groups while accounting for baseline values where applicable.

This study aims to inform patient-centered and ethically responsible communication strategies for discussing AI-supported technologies in perioperative care.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Ağrı, Merkez, Turkey (Türkiye)
        • Ağrı Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured AI Communication
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
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.
Active Comparator: Attention-Control Supportive Communication
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Communication Preoperative Anxiety
Time Frame: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Communication Perceived Control
Time Frame: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.
Post-communication perceived control will be assessed using an adapted 8-item perceived control measure for the healthcare context. Each item is rated on a 5-point Likert scale, with total scores ranging from 8 to 40. Higher scores indicate greater perceived control, defined as the patient's perceived ability to understand the care process, interpret relevant information, and feel oriented within the perioperative care context. The outcome is the post-communication perceived control score measured before surgery, with baseline perceived control accounted for in the analysis.
Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline eHealth Literacy
Time Frame: Baseline before randomization.
Baseline eHealth literacy will be assessed using the eHealth Literacy Scale (eHEALS). The eHEALS includes 8 items rated on a 5-point Likert scale, with total scores ranging from 8 to 40. Higher scores indicate higher perceived ability to find, understand, evaluate, and use electronic health information. eHealth literacy will be assessed as a baseline characteristic and explored as a potential moderator of the intervention effect.
Baseline before randomization.
Post-Communication AI-Related Uncertainty
Time Frame: Baseline before randomization.
AI-related uncertainty will be assessed using a structured 4-item questionnaire developed for this study. Items assess patients' uncertainty about the role of artificial intelligence in perioperative care, whether AI-supported systems replace or support clinical judgment, the presence of professional human oversight, and the relevance of general AI-related information to their individual care. Each item is rated on a 5-point Likert scale, with total scores ranging from 4 to 20. Higher scores indicate greater AI-related uncertainty.
Baseline before randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agri Ibrahim Cecen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Actual)

April 25, 2026

Study Completion (Actual)

April 25, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI-XAI-PA-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study includes sensitive psychological outcome data and a relatively small single-center sample, which may increase the risk of participant re-identification. De-identified aggregate results will be reported in publications and trial results summaries.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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