跳至主要内容
临床试验/NCT06796166
NCT06796166招募中不适用

The Impact of Artificial Intelligence-Supported Preoperative Education on Fear and Anxiety Levels in Total Mastectomy Patients: A Randomized Controlled Trial

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Surgical Fear Questionnaire / SFQ

研究概览

简要总结

This study aims to evaluate the impact of artificial intelligence (AI)-supported preoperative education on fear and anxiety levels in patients undergoing total mastectomy. It is a randomized controlled trial involving two groups: one receiving AI-supported education and the other receiving standard preoperative education. The primary outcomes are to assess changes in surgical fear and anxiety levels. The study targets adult female patients diagnosed with breast cancer who are scheduled for total mastectomy.

详细描述

This study will aim to evaluate the impact of an artificial intelligence (AI)-supported preoperative education program on surgical fear and anxiety levels in patients undergoing total mastectomy. The study will be conducted using an experimental and randomized controlled design, with the control group receiving standard education and the experimental group receiving AI-supported education. The research will be carried out between 2024 and 2025 at the surgical unit of Acıbadem International Hospital.

Breast cancer continues to be the most common cancer type among women worldwide and a significant cause of morbidity and mortality. In Turkey, breast cancer is the most frequently diagnosed cancer among women and remains a leading cause of cancer-related deaths. Patients diagnosed with breast cancer often experience high levels of fear and anxiety, particularly during the surgical process. Literature suggests that between one-quarter and one-third of breast cancer patients develop anxiety during their treatment journey, with some cases progressing to depression.

Surgical fear and anxiety are critical factors that negatively impact the physical and psychological well-being of patients. Anxiety is often triggered by fear of death, uncertainties regarding the recovery process, and a perceived loss of control, while surgical fear focuses on potential physical harm or health risks associated with the surgery. Therefore, interventions to reduce fear and anxiety during the preoperative period will remain crucial.

Preoperative education is an effective method known to increase patient satisfaction and contribute positively to recovery. Traditional educational methods, such as written brochures and verbal instructions, are commonly used. However, these methods may not always be sufficient, particularly for patients experiencing high anxiety levels, as they may struggle to comprehend the information provided. At this point, the integration of technological innovations to make educational materials more interactive and effective has become a necessity. Artificial intelligence (AI) will stand out as one such innovative tool and is expected to enable healthcare professionals to deliver more effective patient education.

AI-supported educational programs will facilitate easier access to information for patients and provide a personalized learning experience. By complementing written and verbal materials, AI will offer interactive communication, allowing patients to ask questions and receive fast, clear, and satisfying responses. Additionally, such an approach will help reduce the workload of healthcare professionals, enabling them to reach a larger number of patients. Given that the number of nurses per capita in Turkey is significantly below the OECD average, these technological solutions will become even more important.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

This study is conducted as an open-label trial. Both participants and investigators are aware of the intervention assignments. The intervention group receives AI-supported preoperative education, while the control group receives standard preoperative education. Masking is not implemented as the nature of the intervention does not allow for blinding.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Literate female patients
  • •Patients who will undergo total mastectomy surgery
  • •Patients diagnosed with breast cancer
  • •Patients who are over 18 years of age
  • •Patients who agree to participate in the study and from whom written consent has been obtained will be included in the study.

排除标准

  • •Patients who cannot understand or communicate in Turkish
  • •Patients with active psychiatric disorders (e.g., major depression, bipolar disorder, schizophrenia)
  • •Patients with advanced hearing or vision problems
  • •Patients with mental disabilities
  • •Patients who have previously participated in a similar training program will be excluded from the study.

研究组 & 干预措施

Digital Education Group

Experimental

Participants in this group will receive AI-supported preoperative education. This intervention involves an interactive, personalized digital education platform designed to reduce surgical fear and anxiety. The program includes detailed information about the surgical process, postoperative care, and emotional coping strategies. The AI platform allows patients to interactively ask questions and receive tailored responses.

干预措施: AI-Supported Preoperative Education (Behavioral)

Traditional Education Group

Active Comparator

Participants in this group will receive standard preoperative education provided by healthcare professionals. The education consists of general information about the surgical process, postoperative care, and strategies for managing fear and anxiety. This group serves as a comparison to the experimental group receiving AI-supported education.

干预措施: Standard Preoperative Education (Behavioral)

结局指标

主要结局

Surgical Fear Questionnaire / SFQ

时间窗: The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.

This outcome evaluates the change in surgical fear levels among participants using the Surgical Fear Questionnaire (SFQ).The scale consists of 8 items rated on an 11-point Likert scale ranging from 0 ("Not afraid at all") to 10 ("Very afraid"). It has two subdimensions, each consisting of 4 items, assessing the source of fear: Items 1-4 evaluate fear related to the short-term outcomes of surgery, while Items 5-8 evaluate fear related to the long-term outcomes. Subscale scores are calculated by summing the scores of the 4 items in each dimension, and the total scale score is obtained by summing the two subscale scores. Subscale scores range from 0 to 40, and the total scale score ranges from 0 to 80. Higher scores indicate higher levels of surgical fear.

State-Trait Anxiety Inventory /STAI

时间窗: The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.

The State-Trait Anxiety Inventory (STAI) is a 20-item scale designed to measure temporary (state) and persistent (trait) anxiety levels. Anxiety is described as an emotional response to actual danger or threats in the environment or as a personality trait with individual differences. The STAI was developed as a self-assessment tool to evaluate the type and level of anxiety. The scale uses a 4-point Likert system, ranging from "Not at all" to "Completely." Twenty items assess state anxiety, while the other 20 items assess trait anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety levels. A score of 0-19 indicates no anxiety, 20-39 indicates low anxiety, 40-59 indicates moderate anxiety, and 60-80 indicates high anxiety. The Trait Anxiety Scale measures the tendency for persistent anxiety in daily life.

次要结局

  • Introductory Information Form(Before the Education)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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