Preoperative Distress and Postoperative Delirium in Elderly Patients Undergoing Major Orthopedic Surgery

NCT07512752 | Recruiting

• 1 other identifier: EFSH-MOC-DT-POD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium

Keywords

Postoperative Delirium; Preoperative Distress; Pain; Length of Hospital Stay

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  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.

  Within the first 3 postoperative days

Secondary Outcomes (1)

• Postoperative Pain Intensity

  Within the first 24 postoperative hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Pain

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Sevim ŞENOL KARATAŞ, MD

CONTACT

05325736611; drsevimkaratas@gmail.com

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: March 27, 2026
• First Posted: April 6, 2026
• Study Start: February 19, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

TU (1)