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

June 9, 2026 updated by: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi

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

Recruiting

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Delirium
Time Frame: Within the first 3 postoperative days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: Within the first 24 postoperative hours

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

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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