BronchoscopyNCT06441149
Individualized Data-based High Simulation of Bronchoscopy Operations in Preoperative Bronchoscopy Informed Consent
A study testing AI-based informed consent and Standard informed consent in people with Bronchoscopy, run by China-Japan Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- AI-based informed consent and Standard informed consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- requiring elective bronchoscopy
- Older than 18 years
Who cannot join
- Dementia, limited speech, or other problems affecting communication
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: 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.
Read more
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
- Being tested
- AI-based informed consent, Standard informed consent
- Keywords
- Communication, Informed Consent, Physician-Patient Relations, AI, bronchoscopy
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based informed consentOther
Patients receiving personalized data-based informed consent procedure before bronchoscopy
Standard informed consentOther
Standard informed consent
| Study group | Role | What they receive |
|---|---|---|
| standard informed consent | Experimental | standard informed consent Receives: Other: Standard informed consent |
| AI-based informed consent | Experimental | Patients receiving personalized data-based informed consent procedure before bronchoscopy Receives: Other: AI-based informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 days before Bronchoscopic procedures
Secondary outcomes (1)
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."
Measured: 1 days after Bronchoscopic procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start14 Jun 2024
- Primary completion30 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441149
- Sponsor's protocol ID
- 2024-AI-informed consent
- Status last verified
- Feb 2025
- First submitted
- 29 May 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Personalized Data-Based Bronchoscopy Simulation Operation System on Perioperative Anxiety and Satisfaction in Bronchoscopy：a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06441149
- Acronym / sponsor ID
- 2024-AI-informed consent
- Conditions
- Bronchoscopy
- Keywords
- Communication, Informed Consent, Physician-Patient Relations, AI, bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard informed consent | Experimental | Other: Standard informed consentstandard informed consent |
| AI-based informed consent | Experimental | Other: AI-based informed consentPatients receiving personalized data-based informed consent procedure before bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- requiring elective bronchoscopy
- Older than 18 years
Key exclusion criteria (1 listed)
- Dementia, limited speech, or other problems affecting communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based informed consentPatients receiving personalized data-based informed consent procedure before bronchoscopy | Other | AI-based informed consent |
| Standard informed consentStandard informed consent | Other | standard informed consent |
Primary outcome
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 secondary outcome
The level of the patient's satisfication
Time frame: 1 days after Bronchoscopic procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based informed consent and Standard informed consent in people with Bronchoscopy, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of the patient's anxiety (time frame: 1 days before Bronchoscopic procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.