Effect of Preoperative Anxiety on Postoperative Delirium... | NCT04216615

Studies
Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.

NCT04216615

Sponsor

Xuzhou Medical University

Status

Unknown status

Last Update Posted

Jan 2, 2020Actual

Enrollment

290Estimated

Phase

Not provided

Conditions

Delirium
Anxiety

Interventions

preoperative anxiety

Countries

Not provided

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2020Estimated

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Oct 1, 2020Estimated

First Submitted Date

Dec 31, 2019

First Submission Date that Met QC Criteria

Dec 31, 2019

First Posted Date

Jan 2, 2020Actual

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

Dec 31, 2019

Last Update Posted Date

Jan 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Postoperative delirium is a common and important complication in patients. The aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in elderly patients undergoing orthopaedic surgery, so as to help develop preventive approaches.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

290Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with preoperative anxiety			Behavioral: preoperative anxiety
patients without preoperative anxiety			Behavioral: preoperative anxiety

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preoperative anxiety	Behavioral	patients who are anxious	patients with preoperative anxiety patients without preoperative anxiety

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative delirium	postoperative delirium is diagnosed using CAM	5-day postoperative period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 65 or older
patients undergoing elective orthopaedic surgery
ASA I-III

Exclusion Criteria:

history of craniocerebral trauma surgery or severe central nervous system disease
inability to read or understand the informed consent documents
too physically or psychologically ill

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

290 elderly patients undergoing elective orthopaedic surgery in the Affiliated Hospital of Xuzhou Medical University.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided