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

Bronchoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441149
• Other study ID #: 2024-AI-informed consent
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 14, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: May 2024
• Source: China-Japan Friendship Hospital
• Contact: Gang Hou, MD
• Phone: 010-84205729
• Email: hougangcmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: August 15, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• requiring elective bronchoscopy

• Older than 18 years

Exclusion Criteria:

· Dementia, limited speech, or other problems affecting communication

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Other:
• AI-based informed consent
Patients receiving personalized data-based informed consent procedure before bronchoscopy
• Standard informed consent
Standard informed consent

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The level of the patient's satisfication	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