DeliriumNCT04216615
Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.
An observational study of Delirium and Anxiety, run by Xuzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- preoperative anxiety
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: 290 elderly patients undergoing elective orthopaedic surgery in the Affiliated Hospital of Xuzhou Medical University.
Who may be able to join
- aged 65 or older
- patients undergoing elective orthopaedic surgery
- ASA I-III
Who cannot join
- 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
About this study
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.
- Being tested
- preoperative anxiety
- Medical subject headings
- Delirium, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative anxietyBehavioural
patients who are anxious
| Study group | Role | What they receive |
|---|---|---|
| patients with preoperative anxiety | Not described Receives: Behavioral: preoperative anxiety | |
| patients without preoperative anxiety | Not described Receives: Behavioral: preoperative anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
postoperative delirium is diagnosed using CAM
Measured: 5-day postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start4 Jan 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Dong Liu, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216615
- Sponsor's protocol ID
- XYFY-2019-0156
- Status last verified
- Dec 2019
- First submitted
- 31 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.
- ClinicalTrials.gov ID
- NCT04216615
- Acronym / sponsor ID
- XYFY-2019-0156
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with preoperative anxiety | – | Behavioral: preoperative anxiety |
| patients without preoperative anxiety | – | Behavioral: preoperative anxiety |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- 290 elderly patients undergoing elective orthopaedic surgery in the Affiliated Hospital of Xuzhou Medical University.
Key inclusion criteria (3 listed)
- aged 65 or older
- patients undergoing elective orthopaedic surgery
- ASA I-III
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative anxietypatients who are anxious | Behavioural | patients with preoperative anxiety, patients without preoperative anxiety |
Primary outcome
Incidence of postoperative delirium
Time frame: 5-day postoperative period
postoperative delirium is diagnosed using CAM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: Undecided. Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Anxiety, run by Xuzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: 5-day postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.