Patient Perception on the Role of Anesthesiologists

April 1, 2019 updated by: Stessel Björn, Jessa Hospital

Patient Perception on the Role of Anesthesiologists: a Survey on the Belgian Perspective

Previous studies showed that the role of the anesthesiologist, their education and role within the hospital is not known by the general public. The lack of knowledge about anesthesia can be an important factor in patients' fear before the planned surgery and can therefore impact patient's general satisfaction. By means of a survey in patients planned for elective surgery, the investigators want to investigate the perception of patients regarding the anesthesiologist, their education and role within the hospital, the general knowledge of the patient regarding anesthesia and possible pre-operative fears and concerns.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction:

Previous studies, mainly performed in the USA and a few in Europe, showed that the role of the anesthesiologist, their education and role within the hospital is not known by the general public (1). Other studies questioned the expectations as well as fear of patients with respect to anesthesia (2). The lack of knowledge about the anesthesia can be an important factor in patients' fear before the planned surgery and can therefore impact patient's general satisfaction. While studies have been performed in several countries, not a single study as far as the investigators know, has been performed in Belgium. Given the fact that the anesthesiologist plays an important role during all stages of surgery (pre-, per-, post-operative), it is important to know how patients experience anesthesia and the role of the anesthesiologist. In this way, possible points of attention can be explored which can lead to a better patient satisfaction in the future.

Outcome measures:

With this study, the investigators want to investigate the perception of patients regarding the anesthesiologist, their education and role within the hospital, the general knowledge of the patient regarding anesthesia and possible pre-operative fears and concerns.

The investigators will determine these outcome measures by performing a survey (standardized questions) which will investigate the following 8 parts:

  • Patient demographics
  • The perception of the role and educational training of the anesthesiologist
  • The role of the anesthesiologist in the hospital
  • General knowledge of anesthesia
  • Trust in medical specialist and anesthesiologist
  • Fear and concerns about anesthesia
  • Patients' expectation regarding recovery and postoperative pain
  • Information for the anesthesiologist and possible points of improvement

Design:

In this monocentric, investigator-initiated, observational, cohort-study, the investigators will perform a survey in all patients that are planned to undergo elective surgery, both ambulatory as well as inpatient surgery. This study will be performed according to the Declaration of Helsinki and will be approved by the Ethical Committee of the Jessa Hospital before the start of the study. A written informed consent will be obtained before participation in the study.

Study Procedures:

Patients that are planned for elective surgery, both ambulatory and inpatient surgery, will be contacted by a researcher prior to the surgery and asked to participate in the study. After a written informed consent is obtained, the survey will be performed by a single researcher, to minimize inter-individual variability. During the survey, family or other people present in the hospital room are not allowed to help the patient. In hospital rooms where more than 1 patient is present, the survey will be performed only once.

Statistical analysis:

Based on previous, comparable studies (1,3,4), 350 patients will be included in this study. Descriptive statistics will be presented as frequencies and percentages of the total amount of patients for categorical variables, while numerical variables will be presented as mean ± SD. Multiple linear regression analysis and correlations will be calculated (depending on normality). A p-value <0.05 is considered statistical significant, while p<0.10 is considered a tendency.

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 (Actual)

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.
350

Contacts and Locations

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

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients from the Jessa Hospital, that are planned for elective surgery (both ambulatory and inpatient surgery)

Description

Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • American Society of Anesthesiology (ASA) physical status classification: 1-3
  • Patients planned to undergo surgery (both ambulatory and inpatient surgery)
  • Patients that speak Dutch, French or English

Exclusion Criteria:

  • Patients that don't speak Dutch, French or English

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

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
The role and educational training of the anesthesiologist
Time Frame: max 1 hour per survey
The patients' perception of the work and educational training of the anesthesiologist
max 1 hour per survey

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 demographics
Time Frame: max 1 hour per survey
Gender, age, highest education level, nationality, language, medical condition
max 1 hour per survey
The role of the anesthesiologist in the hospital
Time Frame: max 1 hour per survey
The patients' perception of the workplace of an anesthesiologist in the hospital
max 1 hour per survey
General knowledge of anesthesia
Time Frame: max 1 hour per survey
The patients' perception of anesthesia in general
max 1 hour per survey
Trust in medical specialist and anesthesiologist
Time Frame: max 1 hour per survey
The patients' trust in the medical specialist and anesthesiologist
max 1 hour per survey
Fear and concerns about anesthesia
Time Frame: max 1 hour per survey
The patients' fear and concerns before the surgery
max 1 hour per survey
Recovery and postoperative pain
Time Frame: max 1 hour per survey
Several questions regarding the patients' expectation of recovery and postoperative pain
max 1 hour per survey
Information for the anesthesiologist and possible points of improvement
Time Frame: max 1 hour per survey
Possible points of improvement for the anesthesiologist
max 1 hour per survey

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.
Jessa Hospital

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.
  • Principal Investigator: Björn Stessel, MD, PhD, Jessa Hospital, Dep. of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 29, 2018

Primary Completion (Actual)

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, 2018

Study Completion (Actual)

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, 2018

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).
January 11, 2018

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.
January 19, 2018

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.
January 26, 2018

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.
April 3, 2019

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.
April 1, 2019

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.
April 1, 2019

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.
  • 18.04/anesth18.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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