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Completed

NCT Number: NCT06441149

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

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.

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Key information

Conditions

Bronchoscopy Behavior Communication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • requiring elective bronchoscopy
  • Older than 18 years

Exclusion criteria

· Dementia, limited speech, or other problems affecting communication

Treatment and study plan

AI-based informed consent

Other

Patients receiving personalized data-based informed consent procedure before bronchoscopy

Standard Informed Consent

Other

Standard informed consent

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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."

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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