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Clinical Trials in Turkey / NCT07766603
Starting soon Not applicable

Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy

NCT07766603 · tracked via the Priya Life Science Turkey tracker
Sponsor
ALİ DEMİRTAŞ
Phase
Not applicable
Started
2026-09
Last updated
2026-08-14

Condition(s) studied

Postoperative Delirium (POD)Prostate Cancer

Investigational drug(s) / intervention(s)

Preoperative Deep Breathing Exercise Training

Preoperative Deep 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.

Study 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 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.

Eligibility

Sex
MALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Akdeniz University Hospital Antalya Antalya

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766603 on ClinicalTrials.gov ↗ ← All trials in Turkey