NCT04216615

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

December 31, 2019

Last Update Submit

December 31, 2019

Conditions

DeliriumAnxiety

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative delirium

    postoperative delirium is diagnosed using CAM

    5-day postoperative period

Study Arms (2)

patients with preoperative anxiety

Behavioral: preoperative anxiety

patients without preoperative anxiety

Behavioral: preoperative anxiety

Interventions

preoperative anxietyBEHAVIORAL

patients who are anxious

patients with preoperative anxietypatients without preoperative anxiety

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DeliriumAnxiety Disorders

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 2, 2020

Study Start

January 4, 2020

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

January 2, 2020

Record last verified: 2019-12