Pre-Anesthesia Visit: Analysis of Coverage Rate of Visit Content and Surgical Patients' Understanding of Information (Pre-Anesthesia)

December 11, 2024 updated by: Anshi Wu

Pre-Anesthesia Visit: Analysis of Coverage Rate of Pre-Anesthesia Visit Content by Anesthesiology Residents, and Surgical Patients' Understanding of Pre-Anesthesia Visit Information

The aim of this study was to systematically assess the coverage of anesthesiology residents' explanations of the content of the visit during the preoperative anesthesia visit and the patients' understanding of the content of the anesthesia approach through the physician's explanations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Physician Component:

In order to minimize the change of the interview content due to third-party supervision, the collected data were analyzed in the form of a questionnaire about the content of the visit after the preoperative visit by anesthesiology residents, including the main content of the visit, the duration of the visit, and the presumed level of patient's understanding of the anesthesia informed consent form.

Patient section:

To investigate the degree of patients' understanding of the contents of the anesthesia visit after listening to the visit. A questionnaire was used to collect the data, which included the content of the visit that the patients could recall, their level of understanding of the content explained by the physician, their concerns, and suggestions for improvement that could be taken to promote patient understanding.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Age stratification of enrolled subjects, 18-80 years [young adults (18-35 years), middle-aged adults (36-60 years), older adults (61-80 years)]；
  2. Stratification of subjects' educational attainment as elementary, middle school, high school, college

Description

Inclusion Criteria:

  • ASA I-II
  • Patients who have not previously undergone surgery under general anesthesia
  • Patients undergoing laparoscopic cholecystectomy or laparoscopic appendectomy

Exclusion Criteria:

  • Subjects who do not wish to participate in this study
  • Patients with visual or auditory impairment
  • Patients who are completely unable to understand the content of the communication or have communication difficulties

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Observation Group

To investigate patients' understanding of the content of the anesthesia visit after listening to the visit. A questionnaire was used to collect data.

The questionnaire included the contents of the visit that the patients could recall, their understanding of the physician's explanation, their concerns, and their suggestions for improving the preoperative visit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients' understanding of the content related to anesthesia visit after the preoperative visit with anesthesiology residents
Time Frame: Postoperative visit （one day after surgery）
Overall patient understanding of the anesthesia visit content was assessed by a patient self-measurement scale in the form of a rank variable, with 1 being no understanding at all and 5 being full understanding
Postoperative visit （one day after surgery）

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient recall of what anesthesiology residents mentioned during the preoperative visit vs. what anesthesiology residents mentioned during the preoperative visit
Time Frame: resident-side：Pre-operative visit-one day before surgery；patient-side：Post-operative visit-one day after surgery
Differences in the content of the preoperative visit as recalled by the patient and the content of the modality as mentioned by the resident through resident-side and patient-side question and answer scales
resident-side：Pre-operative visit-one day before surgery；patient-side：Post-operative visit-one day after surgery
Stratified analysis of subjects according to different age/education levels to explore the relevance in understanding the content of the preoperative visit for anesthesia
Time Frame: Postoperative visit （one day after surgery）
  1. Age stratification as young adults (18-35 years), middle-aged adults (36-60 years), older adults (61-80 years)；
  2. Stratification of subjects' educational attainment as elementary, middle school, high school, college.
Postoperative visit （one day after surgery）

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient concerns in the content of the preoperative approach
Time Frame: Postoperative visit （one day after surgery）
Understanding what worries patients most about anesthesia-related content during the preoperative visit
Postoperative visit （one day after surgery）
Patients' suggestions for improving the efficiency of preoperative anesthesia visits
Time Frame: Postoperative visit （one day after surgery）
Understanding what patients would like to take to promote understanding of the content of the preoperative visit from the patient's end of the spectrum
Postoperative visit （one day after surgery）

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anshi Wu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lina Yang

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAV20241212
  • Pre-Anesthesia Visit (Registry Identifier: PAV20241212)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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