Individualized Data-based High Simulation of Bronchoscopy Operations in Preoperative Bronchoscopy Informed Consent

NCT06441149 | Completed

• 1 other identifier: 2024-AI-informed consent
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized controlled study was conducted to investigate whether preoperative replacement of patients based on AI training instruments could alleviate preoperative anxiety. Patients who met the criteria were randomly assigned to either the personalized data-based group or the control group. Prior to the preoperative account examination, each patient's anxiety level was assessed, after which a 30-40-minute informed consent form was read. The traditional group underwent a preoperative account and question-and-answer session with an experienced bronchoscopy laboratory physician, after which the scale was reassessed. The experimental group underwent a simulated surgical procedure on an AI simulation instrument based on the patient's CT personalized data, performed by an experienced bronchoscopist. The bronchoscopist explained the surgical precautions and answered the patient's questions throughout the procedure. Following the responses to the questions, the scale was reassessed. Following surgery, patients are invited to complete a satisfaction survey prior to discharge or following the discussion of bronchoscopy findings.

Conditions

Bronchoscopy

Keywords

Communication; Informed Consent; Physician-Patient Relations; AI; bronchoscopy

Outcome Measures

Primary Outcomes (1)

• The level of the patient's anxiety

  The modified APAIS questionnaire and the VAS scale were employed to assess anxiety levels before and after informed consent.

  1 days before Bronchoscopic procedures

Secondary Outcomes (1)

• The level of the patient's satisfication

  1 days after Bronchoscopic procedures

Study Arms (2)

standard informed consent

EXPERIMENTAL

standard informed consent

Other: Standard informed consent

AI-based informed consent

EXPERIMENTAL

Patients receiving personalized data-based informed consent procedure before bronchoscopy

Other: AI-based informed consent

Interventions

AI-based informed consent OTHER

Patients receiving personalized data-based informed consent procedure before bronchoscopy

AI-based informed consent

Standard informed consent OTHER

Standard informed consent

standard informed consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• requiring elective bronchoscopy
• Older than 18 years

You may not qualify if:

• · Dementia, limited speech, or other problems affecting communication

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: June 14, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 15, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (1)