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NCT Number: NCT07512752

Preoperative Distress and Postoperative Delirium 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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fethi Sekin City Hospital

Elâzığ, Turkey (Türkiye)

Location status: Recruiting

Location contact

SEVİM ŞENOL KARATAŞ, MD

CONTACT

[email protected]

05325736611

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sevim ŞENOL KARATAŞ, MD

CONTACT

[email protected]

05325736611

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Official study title

The Association Between Preoperative Distress and Postoperative Delirium, Pain, and Length of Hospital Stay in Elderly Patients Undergoing Major Orthopedic Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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