Health TrialsbyHealthPanel

The Impact of AI- Supported Education in Mastectomy Patient

ConditionsBreast CancerAnxietyMastectomyPatient Education as TopicArtificial Intelligence (AI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Literate female patients

Patients who will undergo total mastectomy surgery

Patients diagnosed with breast cancer

Patients who are over 18 years of age

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-Supported Preoperative Education

    Behavioral

    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

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Digital Education GroupExperimental treatment 1 intervention
Group B: Traditional Education GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical Fear Questionnaire / SFQ

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.

Time frame
The scales will be administered twice: 15 minutes before the preoperative education session and 15 minutes after the preoperative education session.
2

State-Trait Anxiety Inventory /STAI

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.

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

Secondary outcomes

1

Introductory Information Form

In the study, the Introductory Information Form, consisting of 17 questions, is a data collection tool developed by the researcher. It includes information about the patients' socio-demographic characteristics (age, gender, marital status, education level, employment status, income level, occupation, and social security) and health history (current diagnosis and date, previous surgical experiences, and the presence of other health problems).

Time frame
Before the Education

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bezmialem Vakif University

Lead sponsor

Acibadem University

Collaborator

Source ClinicalTrials.gov
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