Role of Anesthesiologist-Patient Relationship | NCT00864695

Studies
Role of Anesthesiologist-Patient Relationship

NCT00864695

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Completed

Last Update Posted

Mar 19, 2009Estimated

Enrollment

1,137Actual

Phase

Not provided

Conditions

Preoperative
Anesthesia
Postoperative

Interventions

Supportive care

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Mar 18, 2009

First Submission Date that Met QC Criteria

Mar 18, 2009

First Posted Date

Mar 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

UPECLIN HC FM Botucatu UnespOTHER

Collaborators

Name	Class
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil	OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Descriptive analytic survey of 1137 and 518 patients aged 16 years or more before and after anesthesia exposure, respectively to assess the anesthesiologist-patient relationship role on patient postoperative perception of the binominal anesthesia-anesthesiologist. The aim of this study was to assess the anesthesiologist-patient relationship role on patient postoperative perception of the binominal anesthesia-anesthesiologist.

Period: may/2007 to may/2008

Detailed Description

A questionnaire was used to determine patient characteristics and perception of anesthesia/anesthesiologist, as well as fears and concerns related to anesthesia. This descriptive-analytic study was based on opinions and information provided before and after anesthesia by individuals who were hospitalized in the Botucatu Medical School (BMS) Hospital to undergo surgery under anesthesia administered by the Anesthesiology Service of BMS Department of Anesthesiology. A questionnaire including structured questions aimed at determining patient characteristics (age, gender, race, marital status, education level, birthplace, provenance, surgical service of origin, occupation, history of anesthesia exposure) and perceptions of anesthesiologists/anesthesia, as well as open-ended questions that allowed respondents to add free comments, recorded as spoken, about their concerns before and after anesthesia. The post-anesthesia interview also included questions regarding the administration of pre-anesthetic drugs, recall of the anesthesiologist in the operating room, satisfaction with the care provided by the anesthesiologist.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical patients		Individuals who were hospitalized in the Botucatu Medical School Hospital to undergo surgery under anesthesia administered by the Anesthesiology Service of BMS Department of Anesthesiology.	Other: Supportive care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supportive care	Other	protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Role of anesthesiologist-patient relationship in changing postoperative perception of patients admitted to a teaching hospital		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

conscious surgical patients
16 years or more
Portuguese-speaking patients

Exclusion Criteria:

patients with altered states of consciousness or expression/comprehension impairment
patients who did not undergo anesthesia/surgery (cancelled or postponed)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This descriptive-analytic study was based on opinions and information provided before and after anesthesia by individuals who were hospitalized in the Botucatu Medical School Hospital to undergo surgery under anesthesia. A questionnaire was used to determine patient characteristics and perception of anesthesia/anesthesiologist, as well as fears and concerns related to anesthesia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernanda Leite	College Study of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
College of Medicine of Botucatu		Botucatu	São Paulo	18600-000	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D010166	Palliative Care
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided