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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06441149
Enrollment
122
Registered
2024-06-04
Start date
2024-06-14
Completion date
2024-08-15
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy

Keywords

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

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.

Interventions

OTHERAI-based informed consent

Patients receiving personalized data-based informed consent procedure before bronchoscopy

Standard informed consent

Sponsors

China-Japan Friendship Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* requiring elective bronchoscopy * Older than 18 years

Exclusion criteria

· Dementia, limited speech, or other problems affecting communication

Design outcomes

Primary

MeasureTime frameDescription
The level of the patient's anxiety1 days before Bronchoscopic proceduresThe modified APAIS questionnaire and the VAS scale were employed to assess anxiety levels before and after informed consent.

Secondary

MeasureTime frameDescription
The level of the patient's satisfication1 days after Bronchoscopic proceduresThe post-surgical satisfaction questionnaire consisted of four questions on a 5-point Likert scale, with responses ranging from strongly agree to strongly disagree.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026