- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512752
Preoperative Distress and Postoperative Delirium in Elderly Patients Undergoing Major Orthopedic Surgery
The Association Between Preoperative Distress and Postoperative Delirium, Pain, and Length of Hospital Stay in Elderly Patients Undergoing Major Orthopedic Surgery
Postoperative delirium is a common and serious complication in elderly patients undergoing major orthopedic surgery and is associated with increased morbidity, prolonged hospital stay, and higher healthcare costs. Preoperative psychological distress has been suggested as a potential risk factor influencing postoperative outcomes; however, its relationship with delirium and other clinical outcomes remains insufficiently explored.
This prospective observational study aims to investigate the association between preoperative distress levels and postoperative delirium, pain intensity, and length of hospital stay in elderly patients undergoing major orthopedic surgery. Preoperative distress will be assessed using validated tools, and postoperative outcomes including delirium incidence, pain scores, and hospital stay duration will be recorded and analyzed.
The findings of this study are expected to contribute to improved perioperative risk stratification and may support the development of targeted interventions to reduce postoperative complications in this vulnerable patient population.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: SEVİM ŞENOL KARATAŞ, MD
- Phone Number: 05325736611
- Email: drsevimkaratas@gmail.com
Study Locations
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Elâzığ, Turkey (Türkiye)
- Recruiting
- Fethi Sekin City Hospital
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Contact:
- SEVİM ŞENOL KARATAŞ, MD
- Phone Number: 05325736611
- Email: drsevimkaratas@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of elderly patients aged 65 years and older who are scheduled to undergo major orthopedic surgery, including hip fracture surgery, primary or revision hip arthroplasty, and primary knee arthroplasty, at a tertiary care hospital. Patients who meet the inclusion criteria and provide informed consent (or whose legally authorized representatives provide consent) will be prospectively enrolled.
This population represents a high-risk group for postoperative delirium, and the study aims to evaluate the association between preoperative distress and postoperative outcomes in this clinically relevant and vulnerable patient population.
Description
Inclusion Criteria
- Age ≥65 years
- Undergoing major orthopedic surgery, including:
- Hip fracture surgery
- Primary or revision hip arthroplasty
- Primary knee arthroplasty
- Ability to provide informed consent or availability of a legally authorized representative
Exclusion Criteria
- Known diagnosis of severe dementia or significant cognitive impairment
- Presence of preoperative delirium or an active diagnosis of delirium
- Severe hearing or visual impairment preventing effective communication
- History of intracranial surgery or neurological diseases significantly increasing the risk of delirium (e.g., advanced Parkinson's disease, severe stroke sequelae)
- Planned postoperative sedation in the intensive care unit
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Elderly Patients Undergoing Major Orthopedic Surgery
Elderly patients scheduled for major orthopedic surgery will be enrolled prospectively.
Preoperative distress levels will be assessed before surgery, and postoperative outcomes including delirium, pain intensity, and length of hospital stay will be recorded and analyzed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Postoperative Delirium
Time Frame: Within the first 3 postoperative days
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The primary outcome of the study is the incidence of postoperative delirium in elderly patients undergoing major orthopedic surgery.
Delirium will be assessed during the postoperative period using a validated delirium assessment method.
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Within the first 3 postoperative days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Pain Intensity
Time Frame: Within the first 24 postoperative hours
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Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), a validated 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Pain scores will be recorded at predefined time points (e.g., 2, 6, 12, and 24 hours postoperatively) under resting conditions by trained healthcare personnel. In addition, the association between postoperative pain intensity and preoperative distress levels will be analyzed. |
Within the first 24 postoperative hours
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFSH-MOC-DT-POD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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