Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorALİ DEMİRTAŞ
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Preoperative Deep Breathing Exercise Training
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Preoperative Breathing Exercise TrainingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 postoperativelySecondary outcomes
1
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 postoperatively2
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 period3
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 postoperatively4
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 postoperativelySponsors and contacts
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ALİ DEMİRTAŞ
Lead sponsor
Akdeniz University Hospital
Sponsor institution
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov
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