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Recruiting NCT06796166

The Impact of AI- Supported Education in Mastectomy Patient

No phase Interventional Breast Cancer Anxiety Mastectomy Patient Education as Topic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Supported Preoperative Education, Standard Preoperative Education.
Who it may be relevant to
Registry conditions: Breast Cancer, Anxiety, Mastectomy, Patient Education as Topic. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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 anxie
  • Behavioral 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.

Primary outcome measures

  • Surgical Fear Questionnaire / SFQ [Time frame: The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.]
  • State-Trait Anxiety Inventory /STAI [Time frame: The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.]
Secondary outcome measures (1)
  • Introductory Information Form [Time frame: Before the Education]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Acibadem International Hospital — Istanbul

Publications

  • 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. PMID 36728748

Identifiers

NCT: NCT06796166 · 2024-13/548

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗