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The Impact of AI- Supported Education in Mastectomy Patient

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.

ClinicalTrials.gov IDNCT06796166

PhaseNA

Enrollment40

SponsorBezmialem Vakif University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Anxiety, Mastectomy, Patient Education as Topic, Artificial Intelligence (AI)

About this study

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 anxiety.
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 outcomes

Surgical Fear Questionnaire / SFQ (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 (The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.)

Eligibility information

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.

Study locations

Acibadem International Hospital, Istanbul, Bakirköy 34149 Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.