Clinical trial NCT06796166: The Impact of AI- Supported Education in Mastectomy Patient
Official title: The Impact of Artificial Intelligence-Supported Preoperative Education on Fear and Anxiety Levels in Total Mastectomy Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Anxiety
Mastectomy
Patient Education as Topic
Artificial Intelligence (AI)
Keywords: artificial intelligence
fear of surgery
preoperative education
total mastectomy
breast cancer
surgical anxiety
patient education
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Acibadem University
First posted: 2025-01-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial with a parallel assignment design. Participants are randomly divided into two groups: an intervention group that receives AI-supported preoperative education and a control group that receives standard preoperative education. Both groups are assessed using validated tools to measure surgical fear and anxiety levels before and after the intervention. This design ensures that the impact of the AI-supported education is evaluated in comparison to the standard care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

The primary objective of this study will be to evaluate the effect of an AI-supported preoperative education program on surgical fear and anxiety in total mastectomy patients. The research will adopt a randomized controlled design. Standard education will be provided to the control group, while interactive AI-supported education will be offered to the experimental group via a tablet. The educational content will cover topics such as the operating room environment, invasive procedures, deep breathing and respiratory exercises, spirometer use, postoperative recovery areas, surgical drains, wound care, mobilization, and professional nursing care.

A total of 40 patients will be included in the study, and participants will be randomized equally into experimental (AI-supported education) and control (standard education) groups. Data collection tools will include a Demographic Information Form, the State-Trait Anxiety Inventory (STAI), and the Surgical Fear Questionnaire (SFQ). Data will be analyzed using the SPSS program, with statistical tests such as independent t-tests, chi-square tests, and ANOVA applied to evaluate the differences between groups.

The expected results will show that AI-supported education is an effective method for reducing surgical fear and anxiety. This method is anticipated to save time for healthcare professionals while providing personalized, fast, and continuous education, ultimately improving patient satisfaction. The strengths of the study will include being among the first to test AI-supported education in mastectomy patients and determining the sample size through power analysis. However, limitations may include a small sample size and the study being conducted at a single hospital, which may restrict generalizability.

The research will be conducted with the necessary approvals from ethics committees and hospital administration. Participants' privacy will be safeguarded, and voluntary participation will be ensured. It is expected that AI-supported educational programs will prove to be an effective tool for both healthcare professionals and patients. These findings will serve as an important guide for restructuring educational and support practices for patients in the preoperative period.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Surgical Fear Questionnaire / SFQ
timeFrame: The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.
measure: State-Trait Anxiety Inventory /STAI
timeFrame: The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.
Secondary outcomes:
measure: Introductory Information Form
timeFrame: Before the Education
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem International Hospital
state: Bakirköy
Study officials:
affiliation: Bezmialem Foundation University
name: Mahmut DAGCI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biswas S. ChatGPT and the Future of Medical Writing. Radiology. 2023 Apr;307(2):e223312. doi: 10.1148/radiol.223312. Epub 2023 Feb 2. No abstract available.