Postoperative Delirium (POD)NCT07766603
Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy
A study testing Preoperative Deep Breathing Exercise Training in people with Postoperative Delirium (POD) and Prostate Cancer, run by ALİ DEMİRTAŞ at 1 site in Turkey (Türkiye).
Trial summary
Postoperative delirium is an acute and fluctuating disturbance in attention, awareness, and thinking that may occur after major surgery. Patients undergoing robot-assisted radical prostatectomy may be at risk because of factors such as older age, general anesthesia, prolonged surgery, pneumoperitoneum, and steep… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Postoperative Delirium (POD), Prostate Cancer
- What is being tested?
- Preoperative Deep Breathing Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 40 years or older.
- Scheduled to undergo elective robot-assisted radical prostatectomy (RARP) at -Akdeniz University Hospital.
- Able to communicate and suitable for preoperative and postoperative -cognitive/delirium assessment using the 4AT and Nu-DESC.
- Able and willing to provide written informed consent.
- Availability of clinical follow-up data during the first 48 postoperative hours.
Who cannot join
- Refusal to participate or withdrawal of informed consent.
- History of delirium, severe dementia, severe cognitive impairment, or an active neurological disorder that would interfere with delirium assessment.
- Active psychosis, severe psychiatric disease, or use of psychoactive medication that could substantially affect cognitive assessment.
- Level of consciousness not allowing assessment, or severe hearing or speech impairment preventing adequate communication.
- Emergency surgery or failure to complete the planned procedure as robot-assisted radical prostatectomy.
- Inability to complete the postoperative 4AT and/or Nu-DESC assessments or substantial missing data affecting the primary analysis.
- Inability to tolerate the breathing exercises or insufficient home exercise adherence/follow-up data for the planned analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Akdeniz University Hospital
Antalya, Antalya, (532) 256-8442
ALİ DEMİRTAŞ, 05322568442, alidemirtas@akdeniz.edu.tr
About this study
Official title: Effect of Preoperative Breathing Exercise Training on Postoperative Delirium in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Pilot Study
Postoperative delirium is an acute and fluctuating disturbance in attention, awareness, and thinking that may occur after major surgery. Patients undergoing robot-assisted radical prostatectomy may be at risk because of factors such as older age, general anesthesia, prolonged surgery, pneumoperitoneum, and steep Trendelenburg positioning.
This single-center, prospective, two-arm controlled pilot study will evaluate whether preoperative deep breathing exercise training is associated with a lower occurrence of postoperative delirium in patients undergoing elective robot-assisted radical prostatectomy. A total of 50 patients will be included, with 25 patients in the breathing exercise training group and 25 patients in the control group.
Read more
Patients in the breathing exercise training group will receive standardized, device-free deep breathing exercise instruction during the preoperative period, usually approximately one week before surgery. They will be asked to perform three sessions per day until surgery, with 10 deep breaths in each session. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.
Postoperative delirium will be assessed during the first 48 hours after surgery using the 4AT and Nursing Delirium Screening Scale (Nu-DESC). The study will also evaluate postoperative oxygenation, oxygen requirement, pain, nausea and vomiting, respiratory complications, intensive care requirement, and length of hospital stay. The study will not alter routine anesthesia, surgery, or postoperative treatment, and no additional invasive procedures, laboratory tests, or imaging will be performed for research purposes.
Read the detailed description
Robot-assisted radical prostatectomy (RARP) is a commonly performed minimally invasive surgical procedure for the treatment of prostate cancer. In this population, perioperative factors including advanced age, comorbidities, general anesthesia, pneumoperitoneum, prolonged surgical and anesthetic duration, and steep Trendelenburg positioning may contribute to postoperative respiratory changes and postoperative delirium. Postoperative delirium is characterized by an acute and fluctuating disturbance in attention, awareness, and cognitive function and may be associated with increased complications, prolonged hospitalization, and greater care requirements.
Preoperative breathing exercise training is a noninvasive, nonpharmacological, and low-cost intervention intended to encourage slow, controlled, and deep breathing. Improving patients' familiarity and adherence to breathing exercises before surgery may facilitate postoperative respiratory exercises and may contribute to preservation of oxygenation and reduction of postoperative respiratory complications. These effects may also influence clinical factors associated with postoperative delirium. Evidence regarding the relationship between preoperative breathing exercise training and postoperative delirium specifically in patients undergoing RARP remains limited.
This study is designed as a single-center, prospective, two-arm controlled pilot study and will include 50 male patients aged 40 years or older who are scheduled for elective RARP. Twenty-five patients will be included in the preoperative breathing exercise training group and 25 patients in the control group.
Patients in the intervention group will receive standardized deep breathing exercise training during the preoperative outpatient evaluation, generally approximately one week before surgery. Patients will be instructed to sit in an upright or semi-upright position, relax their shoulders, inhale slowly and deeply through the nose, hold their breath for approximately 2-3 seconds, and then exhale slowly through the mouth. Each session will consist of 10 deep breaths. Patients will be asked to perform the exercises three times daily until the day of surgery. Adherence will be recorded using a home breathing exercise follow-up form and reviewed on the morning of surgery. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.
Routine perioperative anesthesia and surgical management will not be modified because of study participation. Intraoperative variables including anesthesia and surgical duration, pneumoperitoneum duration, Trendelenburg duration when available, oxygen saturation, end-tidal carbon dioxide, intraoperative hypotension, vasopressor or inotrope requirement, estimated blood loss, fluid administration, transfusion, and perioperative complications will be recorded from routine clinical and anesthesia records.
Postoperative delirium will be evaluated during the first 48 hours after surgery. The 4AT will be administered at approximately 24 and 48 hours after surgery, and the Nursing Delirium Screening Scale (Nu-DESC) will be used during the first 12 postoperative hours and again during the 24-48-hour postoperative period. A 4AT score of 4 or greater and/or a Nu-DESC score of 2 or greater will be considered indicative of delirium for the purposes of the study.
Secondary clinical assessments will include 4AT and Nu-DESC scores, postoperative peripheral oxygen saturation, supplemental oxygen requirement, postoperative hypoxemia, clinically documented pulmonary complications or atelectasis, postoperative pain, nausea and vomiting, additional analgesic requirement, intensive care requirement, and length of hospital stay.
No additional medication, invasive procedure, blood sampling, laboratory testing, imaging, or medical device assessment will be performed solely for research purposes. All anesthesia, surgery, treatment, and postoperative care will follow routine clinical practice.
- Conditions
- Postoperative Delirium (POD), Prostate Cancer
- Being tested
- Preoperative Deep Breathing Exercise Training
- Keywords
- Robot-Assisted Radical Prostatectomy, RARP, Preoperative Breathing Exercise, Deep Breathing Exercise, Postoperative Delirium, 4AT, Nu-DESC, Pneumoperitoneum
- Medical subject headings
- Emergence Delirium, Prostatic Neoplasms, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Deep Breathing Exercise TrainingBehavioural
Participants will receive standardized, device-free deep breathing exercise training during the preoperative period. In an upright or semi-upright position, participants will be instructed to relax their shoulders, inhale slowly and deeply through the nose, hold their breath for approximately 2-3 seconds, and then exhale slowly through the mouth. Each session will consist of 10 deep breaths. Participants will be asked to perform three sessions per day from the time of training until surgery. Exercise adherence will be documented using a home follow-up form and reviewed on the morning of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Breathing Exercise Training | Experimental | Participants randomized to this arm will receive standardized preoperative deep breathing exercise training, generally approximately one week before surgery. They will be instructed to perform the exercises three times daily until the day of surgery, with 10 deep breaths in each session. Adherence will be recorded using a home breathing exercise follow-up form. Receives: Behavioral: Preoperative Deep Breathing Exercise Training |
| Control | No intervention | Participants randomized to this arm will receive routine preoperative information and standard perioperative care without additional structured preoperative breathing exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Delirium Within 48 Hours After Surgery
Postoperative delirium will be defined as a 4AT score ≥4 and/or a Nursing Delirium Screening Scale (Nu-DESC) score ≥2 at any prespecified assessment during the first 48 hours after surgery. The 4AT will be assessed at 24 and 48 hours postoperatively, and the Nu-DESC will be assessed during the first 12 postoperative hours and again during the 24-48-hour postoperative period. The outcome will be reported as the number and proportion of participants who develop postoperative delirium.
Measured: From the end of surgery through 48 hours postoperatively
Secondary outcomes (5)
4AT Delirium Screening Score
The 4AT will be used to assess postoperative delirium-related symptoms. The total score ranges from 0 to 12, with higher scores indicating greater likelihood of delirium. A score ≥4 indicates a high likelihood of delirium. Scores will be recorded at 24 and 48 hours after surgery.
Measured: At 24 and 48 hours postoperatively
Nursing Delirium Screening Scale (Nu-DESC) Score
The Nu-DESC will be used to assess postoperative delirium-related symptoms. The total score ranges from 0 to 10, with higher scores indicating more delirium-related symptoms. A score ≥2 indicates a high likelihood of delirium.
Measured: During the first 12 postoperative hours and during the 24-48-hour postoperative period
Peripheral Oxygen Saturation (SpO₂) at Predefined Postoperative Time Points
Peripheral oxygen saturation (SpO₂), expressed as a percentage, will be recorded from routine clinical monitoring at predefined postoperative time points.
Measured: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Number of Participants Requiring Supplemental Oxygen Postoperatively
The need for supplemental oxygen will be recorded at predefined postoperative assessments. The number and proportion of participants requiring supplemental oxygen will be compared between study groups.
Measured: From the PACU/early postoperative period through 48 hours postoperatively
Postoperative Pain Score on the NRS/VAS
Postoperative pain intensity will be assessed using a 0-10 Numerical Rating Scale/Visual Analog Scale (NRS/VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Delirium (POD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a preoperative breathing exercise training group or a control group receiving routine preoperative information. Group allocation will be performed using the sealed-envelope method. Sequentially numbered, opaque, sealed envelopes will be used to ensure allocation concealment and will be opened only after the participant has been enrolled in the study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALİ DEMİRTAŞ
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, ALİ DEMİRTAŞ, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766603
- Sponsor's protocol ID
- RARP-BREATH-2026-01
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) are not planned to be shared publicly. Study data will be coded and stored securely, and study findings will be reported in aggregate form to protect participant confidentiality and privacy.
Publications
Gaudreau JD, Gagnon P, Harel F, Tremblay A, Roy MA. Fast, systematic, and continuous delirium assessment in hospitalized patients: the nursing delirium screening scale. J Pain Symptom Manage. 2005 Apr;29(4):368-75. doi: 10.1016/j.jpainsymman.2004.07.009.
PubMed 15857740Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2.
PubMed 24590568Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Breathing Exercise Training on Postoperative Delirium in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07766603
- Acronym / sponsor ID
- RARP-BREATH-2026-01
- Conditions
- Postoperative Delirium (POD), Prostate Cancer
- Keywords
- Robot-Assisted Radical Prostatectomy, RARP, Preoperative Breathing Exercise, Deep Breathing Exercise, Postoperative Delirium, 4AT, Nu-DESC, Pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ALİ DEMİRTAŞUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Aug 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 an acute and fluctuating disturbance in attention, awareness, and thinking that may occur after major surgery. Patients undergoing robot-assisted radical prostatectomy may be at risk because of factors such as older age, general anesthesia, prolonged surgery, pneumoperitoneum, and steep Trendelenburg positioning.
This single-center, prospective, two-arm controlled pilot study will evaluate whether preoperative deep breathing exercise training is associated with a lower occurrence of postoperative delirium in patients undergoing elective robot-assisted radical prostatectomy. A total of 50 patients will be included, with 25 patients in the breathing exercise training group and 25 patients in the control group.
Patients in the breathing exercise training group will receive standardized, device-free deep breathing exercise instruction during the preoperative period, usually approximately one week before surgery. They will be asked to perform three sessions per day until surgery, with 10 deep breaths in each session. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.
Postoperative delirium will be assessed during the first 48 hours after surgery using the 4AT and Nursing Delirium Screening Scale (Nu-DESC). The study will also evaluate postoperative oxygenation, oxygen requirement, pain, nausea and vomiting, respiratory complications, intensive care requirement, and length of hospital stay. The study will not alter routine anesthesia, surgery, or postoperative treatment, and no additional invasive procedures, laboratory tests, or imaging will be performed for research purposes.
Detailed description
Robot-assisted radical prostatectomy (RARP) is a commonly performed minimally invasive surgical procedure for the treatment of prostate cancer. In this population, perioperative factors including advanced age, comorbidities, general anesthesia, pneumoperitoneum, prolonged surgical and anesthetic duration, and steep Trendelenburg positioning may contribute to postoperative respiratory changes and postoperative delirium. Postoperative delirium is characterized by an acute and fluctuating disturbance in attention, awareness, and cognitive function and may be associated with increased complications, prolonged hospitalization, and greater care requirements.
Preoperative breathing exercise training is a noninvasive, nonpharmacological, and low-cost intervention intended to encourage slow, controlled, and deep breathing. Improving patients' familiarity and adherence to breathing exercises before surgery may facilitate postoperative respiratory exercises and may contribute to preservation of oxygenation and reduction of postoperative respiratory complications. These effects may also influence clinical factors associated with postoperative delirium. Evidence regarding the relationship between preoperative breathing exercise training and postoperative delirium specifically in patients undergoing RARP remains limited.
This study is designed as a single-center, prospective, two-arm controlled pilot study and will include 50 male patients aged 40 years or older who are scheduled for elective RARP. Twenty-five patients will be included in the preoperative breathing exercise training group and 25 patients in the control group.
Patients in the intervention group will receive standardized deep breathing exercise training during the preoperative outpatient evaluation, generally approximately one week before surgery. Patients will be instructed to sit in an upright or semi-upright position, relax their shoulders, inhale slowly and deeply through the nose, hold their breath for approximately 2-3 seconds, and then exhale slowly through the mouth. Each session will consist of 10 deep breaths. Patients will be asked to perform the exercises three times daily until the day of surgery. Adherence will be recorded using a home breathing exercise follow-up form and reviewed on the morning of surgery. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.
Routine perioperative anesthesia and surgical management will not be modified because of study participation. Intraoperative variables including anesthesia and surgical duration, pneumoperitoneum duration, Trendelenburg duration when available, oxygen saturation, end-tidal carbon dioxide, intraoperative hypotension, vasopressor or inotrope requirement, estimated blood loss, fluid administration, transfusion, and perioperative complications will be recorded from routine clinical and anesthesia records.
Postoperative delirium will be evaluated during the first 48 hours after surgery. The 4AT will be administered at approximately 24 and 48 hours after surgery, and the Nursing Delirium Screening Scale (Nu-DESC) will be used during the first 12 postoperative hours and again during the 24-48-hour postoperative period. A 4AT score of 4 or greater and/or a Nu-DESC score of 2 or greater will be considered indicative of delirium for the purposes of the study.
Secondary clinical assessments will include 4AT and Nu-DESC scores, postoperative peripheral oxygen saturation, supplemental oxygen requirement, postoperative hypoxemia, clinically documented pulmonary complications or atelectasis, postoperative pain, nausea and vomiting, additional analgesic requirement, intensive care requirement, and length of hospital stay.
No additional medication, invasive procedure, blood sampling, laboratory testing, imaging, or medical device assessment will be performed solely for research purposes. All anesthesia, surgery, treatment, and postoperative care will follow routine clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a preoperative breathing exercise training group or a control group receiving routine preoperative information. Group allocation will be performed using the sealed-envelope method. Sequentially numbered, opaque, sealed envelopes will be used to ensure allocation concealment and will be opened only after the participant has been enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| Preoperative Breathing Exercise Training | Experimental | Behavioral: Preoperative Deep Breathing Exercise TrainingParticipants randomized to this arm will receive standardized preoperative deep breathing exercise training, generally approximately one week before surgery. They will be instructed to perform the exercises three times daily until the day of surgery, with 10 deep breaths in each session. Adherence will be recorded using a home breathing exercise follow-up form. |
| Control | No intervention | –Participants randomized to this arm will receive routine preoperative information and standard perioperative care without additional structured preoperative breathing exercise training. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 40 years or older.
- Scheduled to undergo elective robot-assisted radical prostatectomy (RARP) at -Akdeniz University Hospital.
- Able to communicate and suitable for preoperative and postoperative -cognitive/delirium assessment using the 4AT and Nu-DESC.
- Able and willing to provide written informed consent.
- Availability of clinical follow-up data during the first 48 postoperative hours.
Key exclusion criteria (7 listed)
- Refusal to participate or withdrawal of informed consent.
- History of delirium, severe dementia, severe cognitive impairment, or an active neurological disorder that would interfere with delirium assessment.
- Active psychosis, severe psychiatric disease, or use of psychoactive medication that could substantially affect cognitive assessment.
- Level of consciousness not allowing assessment, or severe hearing or speech impairment preventing adequate communication.
- Emergency surgery or failure to complete the planned procedure as robot-assisted radical prostatectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Deep Breathing Exercise TrainingParticipants will receive standardized, device-free deep breathing exercise training during the preoperative period. In an upright or semi-upright position, participants will be instructed to relax their shoulders, inhale slowly and deeply through the nose, hold their breath for approximately 2-3 seconds, and then exhale slowly through the mouth. Each session will consist of 10 deep breaths. Participants will be asked to perform three sessions per day from the time of training until surgery. Exercise adherence will be documented using a home follow-up form and reviewed on the morning of surgery. | Behavioural | Preoperative Breathing Exercise Training |
Primary outcome
Number of Participants With Postoperative Delirium Within 48 Hours After Surgery
Time frame: From the end of surgery through 48 hours postoperatively
Postoperative delirium will be defined as a 4AT score ≥4 and/or a Nursing Delirium Screening Scale (Nu-DESC) score ≥2 at any prespecified assessment during the first 48 hours after surgery. The 4AT will be assessed at 24 and 48 hours postoperatively, and the Nu-DESC will be assessed during the first 12 postoperative hours and again during the 24-48-hour postoperative period. The outcome will be reported as the number and proportion of participants who develop postoperative delirium.
5 secondary outcomes
4AT Delirium Screening Score
Time frame: At 24 and 48 hours postoperatively
Nursing Delirium Screening Scale (Nu-DESC) Score
Time frame: During the first 12 postoperative hours and during the 24-48-hour postoperative period
Peripheral Oxygen Saturation (SpO₂) at Predefined Postoperative Time Points
Time frame: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Number of Participants Requiring Supplemental Oxygen Postoperatively
Time frame: From the PACU/early postoperative period through 48 hours postoperatively
Postoperative Pain Score on the NRS/VAS
Time frame: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 15857740Gaudreau JD, Gagnon P, Harel F, Tremblay A, Roy MA. Fast, systematic, and continuous delirium assessment in hospitalized patients: the nursing delirium screening scale. J Pain Symptom Manage. 2005 Apr;29(4):368-75. doi: 10.1016/j.jpainsymman.2004.07.009.
- Background: PubMed 24590568Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) are not planned to be shared publicly. Study data will be coded and stored securely, and study findings will be reported in aggregate form to protect participant confidentiality and privacy.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Deep Breathing Exercise Training in people with Postoperative Delirium (POD) and Prostate Cancer, run by ALİ DEMİRTAŞ 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALİ DEMİRTAŞ, Lucterer (+905322568442, alidemirtas@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Delirium Within 48 Hours After Surgery (time frame: From the end of surgery through 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07766603, which also lists 3 linked publications.
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 14 Aug 2026.