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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411694
Other study ID # 18.04/anesth18.01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 29, 2018
Est. completion date December 30, 2018

Study information

Verified date April 2019
Source Jessa Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Survey in patients from the Jessa Hospital that are planned for elective surgery, both ambulatory and inpatient.

Locations

Country Name City State
Belgium Jessa Hospital Hasselt

Sponsors (1)

Lead Sponsor Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Chew ST, Tan T, Tan SS, Ip-Yam PC. A survey of patients' knowledge of anaesthesia and perioperative care. Singapore Med J. 1998 Sep;39(9):399-402. — View Citation

Gottschalk A, Seelen S, Tivey S, Gottschalk A, Rich G. What do patients know about anesthesiologists? Results of a comparative survey in an U.S., Australian, and German university hospital. J Clin Anesth. 2013 Mar;25(2):85-91. doi: 10.1016/j.jclinane.2012.06.017. Epub 2013 Jan 17. — View Citation

Hariharan S, Merritt-Charles L, Chen D. Patient perception of the role of anesthesiologists: a perspective from the Caribbean. J Clin Anesth. 2006 Nov;18(7):504-9. — View Citation

Nagrampa D, Bazargan-Hejazi S, Neelakanta G, Mojtahedzadeh M, Law A, Miller M. A survey of anesthesiologists' role, trust in anesthesiologists, and knowledge and fears about anesthesia among predominantly Hispanic patients from an inner-city county preoperative anesthesia clinic. J Clin Anesth. 2015 Mar;27(2):97-104. doi: 10.1016/j.jclinane.2014.05.012. Epub 2015 Jan 17. — View Citation

Outcome

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