Effects of Structured Communication About Artificial Intelligence in Perioperative Care on Preoperative Anxiety and Perceived Control: An Attention-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Preoperative Anxiety Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Structured Artificial Intelligence Communication (Behavioral)
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.
干预措施: Attention-Control Supportive Communication (Other)
结局指标
主要结局
Change in Preoperative Anxiety Level
时间窗: From baseline (before randomization) to immediately after the intervention and before surgery (approximately 10-15 minutes total).
Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The primary outcome is the change in anxiety score between baseline (before randomization, T0) and after the intervention (prior to surgery, T1). Higher scores indicate higher levels of preoperative anxiety.
Post-Communication Preoperative Anxiety
时间窗: 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.
次要结局
- Change in Perceived Control Level(From baseline (before randomization) to immediately after the intervention and before surgery (approximately 10-15 minutes total).)
- Post-Communication Perceived Control(Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.)
研究者
Volkan Gokmen
Assistant Professor
Agri Ibrahim Cecen University