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

February 7, 2025 updated by: Gang Hou, China-Japan Friendship Hospital

The Impact of a Personalized Data-Based Bronchoscopy Simulation Operation System on Perioperative Anxiety and Satisfaction in Bronchoscopy：a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

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

  • China
    • Beijing
      • BeiJing, Beijing, China, 100029
        • China-Japan Friendship Hospital

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

No

Description

Inclusion Criteria:

  • requiring elective bronchoscopy
  • Older than 18 years

Exclusion Criteria:

· Dementia, limited speech, or other problems affecting communication

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard informed consent
Other: Standard informed consent
Standard informed consent
Experimental: AI-based informed consent
Patients receiving personalized data-based informed consent procedure before bronchoscopy
Other: AI-based informed consent
Patients receiving personalized data-based informed consent procedure before bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of the patient's anxiety
Time Frame: 1 days before Bronchoscopic procedures
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of the patient's satisfication
Time Frame: 1 days after Bronchoscopic procedures
The post-surgical satisfaction questionnaire consisted of four questions on a 5-point Likert scale, with responses ranging from "strongly agree" to "strongly disagree."
1 days after Bronchoscopic procedures

Collaborators and Investigators

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

Sponsor

China-Japan Friendship Hospital

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)

June 14, 2024

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-AI-informed consent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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