An interventional study of Preoperative Deep Breathing Exercise Training in Postoperative Delirium (POD) and Prostate Cancer, sponsored by ALİ DEMİRTAŞ. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by ALİ DEMİRTAŞ · Not applicable, Interventional, and Prevention
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.
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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →This is the only study on the registry with ALİ DEMİRTAŞ as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Preoperative Deep Breathing Exercise Training
Participants randomized to this arm will receive routine preoperative information and standard perioperative care without additional structured preoperative breathing exercise training.
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.
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.
Time frame: From the end of surgery through 48 hours postoperatively
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.
Time frame: 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.
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
Peripheral oxygen saturation (SpO₂), expressed as a percentage, will be recorded from routine clinical monitoring 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
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.
Time frame: 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.
Time frame: PACU/early postoperative period and at 6, 24, and 48 hours postoperatively
Plan to share: 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.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.