NCT07766603Not yet recruiting
Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy
Effect of Preoperative Breathing Exercise Training on Postoperative Delirium in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- ALİ DEMİRTAŞ
- Diseases
- Prostate cancer
- NCT number
- NCT07766603
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Sept 2026 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Refusal to participate or withdrawal of informed consent.
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akdeniz University Hospital Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.