Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Delirium (POD) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative Deep Breathing Exercise Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative Breathing Exercise Training
- description
- 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.
- interventionNames
- Behavioral: Preoperative Deep Breathing Exercise Training
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants randomized to this arm will receive routine preoperative information and standard perioperative care without additional structured preoperative breathing exercise training.
Primary outcomes (1)
- measure
- Number of Participants With Postoperative Delirium Within 48 Hours After Surgery
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (3)
- BACKGROUNDGaudreau 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. PMID 15857740
- BACKGROUNDBellelli 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. PMID 24590568
- BACKGROUNDInouye 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. PMID 23992774