Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT03411694
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Perception on the Role of Anesthesiologists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The role and educational training of the anesthesiologist', 'timeFrame': 'max 1 hour per survey', 'description': "The patients' perception of the work and educational training of the anesthesiologist"}], 'secondaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'max 1 hour per survey', 'description': 'Gender, age, highest education level, nationality, language, medical condition'}, {'measure': 'The role of the anesthesiologist in the hospital', 'timeFrame': 'max 1 hour per survey', 'description': "The patients' perception of the workplace of an anesthesiologist in the hospital"}, {'measure': 'General knowledge of anesthesia', 'timeFrame': 'max 1 hour per survey', 'description': "The patients' perception of anesthesia in general"}, {'measure': 'Trust in medical specialist and anesthesiologist', 'timeFrame': 'max 1 hour per survey', 'description': "The patients' trust in the medical specialist and anesthesiologist"}, {'measure': 'Fear and concerns about anesthesia', 'timeFrame': 'max 1 hour per survey', 'description': "The patients' fear and concerns before the surgery"}, {'measure': 'Recovery and postoperative pain', 'timeFrame': 'max 1 hour per survey', 'description': "Several questions regarding the patients' expectation of recovery and postoperative pain"}, {'measure': 'Information for the anesthesiologist and possible points of improvement', 'timeFrame': 'max 1 hour per survey', 'description': 'Possible points of improvement for the anesthesiologist'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Survey', 'Anesthesia', 'Anesthesiologist', 'Patient perspective'], 'conditions': ['Anesthesia', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '25605048', 'type': 'BACKGROUND', '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."}, {'pmid': '9885718', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '17126778', 'type': 'BACKGROUND', '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. doi: 10.1016/j.jclinane.2006.03.004.'}, {'pmid': '23333789', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Introduction:\n\nPrevious 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.\n\nOutcome measures:\n\nWith 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.\n\nThe investigators will determine these outcome measures by performing a survey (standardized questions) which will investigate the following 8 parts:\n\n* Patient demographics\n* The perception of the role and educational training of the anesthesiologist\n* The role of the anesthesiologist in the hospital\n* General knowledge of anesthesia\n* Trust in medical specialist and anesthesiologist\n* Fear and concerns about anesthesia\n* Patients' expectation regarding recovery and postoperative pain\n* Information for the anesthesiologist and possible points of improvement\n\nDesign:\n\nIn 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.\n\nStudy Procedures:\n\nPatients 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.\n\nStatistical analysis:\n\nBased 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from the Jessa Hospital, that are planned for elective surgery (both ambulatory and inpatient surgery)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females ≥ 18 years of age\n* American Society of Anesthesiology (ASA) physical status classification: 1-3\n* Patients planned to undergo surgery (both ambulatory and inpatient surgery)\n* Patients that speak Dutch, French or English\n\nExclusion Criteria:\n\n* Patients that don't speak Dutch, French or English"}, 'identificationModule': {'nctId': 'NCT03411694', 'briefTitle': 'Patient Perception on the Role of Anesthesiologists', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'Patient Perception on the Role of Anesthesiologists: a Survey on the Belgian Perspective', 'orgStudyIdInfo': {'id': '18.04/anesth18.01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Survey in patients from the Jessa Hospital that are planned for elective surgery, both ambulatory and inpatient.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Björn Stessel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jessa Hospital, Dep. of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Anesthesiologist, MD, PhD', 'investigatorFullName': 'Stessel Björn', 'investigatorAffiliation': 'Jessa Hospital'}}}}