AI Screening for BDD in Aesthetic Surgery: Enhancing Safety and Outcomes (AI)

August 30, 2024 updated by: Bukret Plastic Surgery

Artificial Intelligence Screening for Body Dysmorphic Disorder in Aesthetic Surgery: Improving Patient Safety and Outcomes

The goal of this observational study is to evaluate the effectiveness of an AI-powered screening tool for Body Dysmorphic Disorder (BDD) among patients seeking aesthetic surgery. The study aims to determine if the AI system can effectively identify patients at risk for BDD and assess the impact of early psychological intervention on surgical decision-making and outcomes. Participants will complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ). The study will track the correlation between BDD, age, stress levels, and gender to better understand the prevalence and implications of BDD in cosmetic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This observational study evaluates an AI-powered screening tool for Body Dysmorphic Disorder (BDD) in patients seeking elective aesthetic surgery. The study is designed to assess the effectiveness of the AI system in identifying individuals at risk for BDD, facilitating timely psychological interventions, and improving surgical outcomes.

Study Overview:

Study Population and Inclusion Criteria: Patients aged 18 and older seeking elective cosmetic surgery at a solo practice are included. All participants complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ) integrated within the AI system.

AI-Based Risk Assessment: The AI system utilizes data from the BDDQ, along with demographic and psychological factors, to generate a risk score for BDD. This risk score informs the clinical decision-making process, particularly in determining the eligibility for surgery and the need for psychological intervention.

Data Collection and Management: Data is collected through a secure online platform where participants complete the necessary questionnaires. The AI system analyzes the data to generate individualized risk profiles. The study implements rigorous quality assurance processes, including automated data validation checks and source data verification, to ensure the reliability and accuracy of the data.

Statistical Analysis: The study employs correlation analysis to explore the relationships between BDD, age, gender, and stress levels. Chi-square tests are used to assess the statistical significance of differences between demographic groups. The analysis plan includes handling missing data through imputation techniques and conducting sensitivity analyses to validate the robustness of the findings.

Outcome Measures: Primary outcomes include the prevalence of BDD among the study population and the correlations between BDD and key demographic factors. Secondary outcomes focus on the effectiveness of the AI system in enhancing surgical decision-making and improving patient satisfaction.

Ethical Considerations: The study adheres to ethical guidelines, including obtaining informed consent from all participants and anonymizing data to protect privacy. The study is conducted in accordance with the Declaration of Helsinki, and institutional review board approval was deemed unnecessary due to the non-invasive nature of the screening.

Study Limitations: The study acknowledges potential limitations, including the relatively small number of patients who proceeded with surgery, which may affect the generalizability of the findings. Further research is recommended to explore the AI system's effectiveness across diverse populations and clinical settings.

Study Type

Observational

Enrollment (Actual)

3722

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1107
        • Bukret Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population includes individuals aged 18 years or older who are seeking elective cosmetic surgery at a private practice in Buenos Aires, Argentina. All participants are required to complete an AI-based Body Dysmorphic Disorder (BDD) screening questionnaire as part of the preoperative evaluation. The study aims to assess the prevalence of BDD and its correlation with various risk factors within this population.

Description

Inclusion Criteria:

  • Patients aged 18 years or older
  • Completion of the AI-based Body Dysmorphic Disorder Questionnaire (BDDQ)

Exclusion Criteria:

  • Individuals under the age of 18 years
  • Incomplete or refusal to complete the BDDQ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AI-Screened Cosmetic Surgery Patients
This cohort consists of patients aged 18 years or older who are undergoing elective cosmetic surgery. All participants in this group have undergone an AI-powered Body Dysmorphic Disorder (BDD) screening, which includes the completion of the Body Dysmorphic Disorder Questionnaire (BDDQ) and additional psychological evaluations. The AI system provides a risk assessment for BDD, guiding the surgical decision-making process and identifying patients who may require psychological intervention before proceeding with surgery.
Procedure: AI-Powered Body Dysmorphic Disorder Screening Procedure
The AI-Powered Body Dysmorphic Disorder Screening Procedure involves using an AI tool to evaluate patients for Body Dysmorphic Disorder (BDD) before undergoing elective cosmetic surgery. The screening integrates the Body Dysmorphic Disorder Questionnaire (BDDQ) with additional psychological assessments. The AI system processes the collected data to produce a risk score, guiding surgeons in making informed decisions about the need for psychological evaluation or intervention, and determining the suitability of patients for surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Body Dysmorphic Disorder (BDD) Among Cosmetic Surgery Patients
Time Frame: From 1 to 43 months post-surgery (January 2021 to August 2024)
This outcome measure assesses the prevalence of BDD among patients undergoing cosmetic surgery, as identified through the AI-powered screening tool.
From 1 to 43 months post-surgery (January 2021 to August 2024)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Positive BDD Screening and Risk Factors
Time Frame: From 1 to 43 months post-surgery (January 2021 to August 2024)
This measure evaluates the correlation between a positive Body Dysmorphic Disorder (BDD) screening result and various risk factors, including demographic factors (age, gender), psychological stress levels, and previous psychiatric history. The goal is to identify patterns that could inform better patient selection and management in cosmetic surgery.
From 1 to 43 months post-surgery (January 2021 to August 2024)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukret Plastic Surgery

Investigators

  • Principal Investigator: Williams E Bukret, MD, EMBA, Bukret Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2021

Primary Completion (Actual)

August 23, 2024

Study Completion (Actual)

August 23, 2024

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BukretAI-BDD2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. Data will be available to other researchers upon reasonable request, subject to approval by the principal investigator, Dr. Williams Erik Bukret. The data will be shared through a secure data-sharing platform.

IPD Sharing Time Frame

IPD and supporting information will be available starting 6 months after publication of the study results and will remain available for 1 year.

IPD Sharing Access Criteria

IPD and supporting information will be available to researchers who provide a methodologically sound proposal, which must be approved by the principal investigator, Dr. Williams Erik Bukret. Access will be granted for the purpose of academic research, and the data will be shared through a secure data-sharing platform upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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