NCT06796166

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 9, 2024

Last Update Submit

January 28, 2025

Conditions

Breast CancerAnxietyMastectomyPatient Education as TopicArtificial Intelligence (AI)

Keywords

artificial intelligencefear of surgerypreoperative educationtotal mastectomybreast cancersurgical anxietypatient education

Outcome Measures

Primary Outcomes (2)

  • 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.

    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 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.

    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

    Before the Education

Study Arms (2)

Digital Education Group

EXPERIMENTAL

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.

Behavioral: AI-Supported Preoperative Education

Traditional Education Group

ACTIVE COMPARATOR

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.

Behavioral: Standard Preoperative Education

Interventions

AI-Supported Preoperative EducationBEHAVIORAL

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.

Digital Education Group
Standard Preoperative EducationBEHAVIORAL

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.

Traditional Education Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is limited to female participants because it focuses on conditions and interventions specific to women, particularly those undergoing mastectomy for breast cancer treatment.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem International Hospital

Istanbul, Bakirköy, 34149, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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: 36728748BACKGROUND

Related Links

MeSH Terms

Conditions

Breast NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Officials

  • Mahmut DAGCI, PhD

    Bezmialem Foundation University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmut DAĞCI, PhD

CONTACT

+90 05547618939MDagci@bezmialem.edu.tr

Gamze ORHAN, M. Sc.

CONTACT

+90 5302473293orhangamze34@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is conducted as an open-label trial. Both participants and investigators are aware of the intervention assignments. The intervention group receives AI-supported preoperative education, while the control group receives standard preoperative education. Masking is not implemented as the nature of the intervention does not allow for blinding.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

January 28, 2025

Study Start

August 1, 2024

Primary Completion

February 1, 2025

Study Completion

August 1, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the sensitive nature of the data and privacy considerations for patients undergoing total mastectomy. Additionally, the institutional policies do not require sharing of IPD for this type of study.

Locations

TU(1)