Postoperative DeliriumNCT07512752
Preoperative Distress and Postoperative Delirium in Elderly Patients Undergoing Major Orthopedic Surgery
An observational study of Postoperative Delirium, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2026to 19 Jun 2026
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative Delirium, Preoperative Distress, Pain, Length of Hospital Stay
- Medical subject headings
- Emergence Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 3 postoperative days
Secondary outcomes (1)
Postoperative Pain Intensity
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.
Measured: Within the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start19 Feb 2026
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512752
- Sponsor's protocol ID
- EFSH-MOC-DT-POD
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Preoperative Distress and Postoperative Delirium, Pain, and Length of Hospital Stay in Elderly Patients Undergoing Major Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07512752
- Acronym / sponsor ID
- EFSH-MOC-DT-POD
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative Delirium, Preoperative Distress, Pain, Length of Hospital Stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 6 Apr 2026 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥65 years
- Undergoing major orthopedic surgery, including:
- Hip fracture surgery
- Primary or revision hip arthroplasty
- Primary knee arthroplasty
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Postoperative Pain Intensity
Time frame: Within the first 24 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Within the first 3 postoperative days). 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 11 Sep 2026.