The Impact of AI- Supported Education in Mastectomy Patient
NCT ID: NCT06796166
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2024-08-01
2025-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Education Given at Different Times Before a Breast Biopsy
NCT05656612
The Effect of Training Given by Mobile Application to Women Undergoing Breast Surgery
NCT04914780
The Effect of Mobile Application-based Information About Before and After Surgery
NCT05360407
Effect of Education on Breast Cancer Fear and Health Beliefs
NCT06543147
The Effect of a Health Belief Model-Based Education Program on Breast Self-Examination Practice Behavior, Breast Cancer Fear, and Awareness Levels in Women: A Randomized Controlled Trial
NCT07348744
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Digital Education Group
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.
AI-Supported Preoperative Education
This intervention involves the use of a pre-trained AI-powered education platform designed to provide preoperative information to patients undergoing mastectomy. The program delivers structured, interactive education that includes details about the surgical process, postoperative care, and emotional coping strategies. The pre-trained AI system offers standardized responses to patient questions, ensuring consistency and clarity in the information provided, with the goal of reducing fear and anxiety.
Traditional Education Group
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.
Standard Preoperative Education
This intervention consists of standard preoperative education provided by healthcare professionals. Patients receive general information about the surgical procedure, postoperative care, and strategies to manage fear and anxiety. The education is delivered in a traditional, face-to-face format without the use of AI or digital tools.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AI-Supported Preoperative Education
This intervention involves the use of a pre-trained AI-powered education platform designed to provide preoperative information to patients undergoing mastectomy. The program delivers structured, interactive education that includes details about the surgical process, postoperative care, and emotional coping strategies. The pre-trained AI system offers standardized responses to patient questions, ensuring consistency and clarity in the information provided, with the goal of reducing fear and anxiety.
Standard Preoperative Education
This intervention consists of standard preoperative education provided by healthcare professionals. Patients receive general information about the surgical procedure, postoperative care, and strategies to manage fear and anxiety. The education is delivered in a traditional, face-to-face format without the use of AI or digital tools.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acibadem University
OTHER
Bezmialem Vakif University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mahmut DAGCI, PhD
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Foundation University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Acibadem International Hospital
Istanbul, Bakirköy, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Provides global cancer statistics and projections, focusing on breast cancer
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-13/548
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.