Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy

NCT07766603 | Not Yet Recruiting

• 1 other identifier: RARP-BREATH-2026-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium (POD); Prostate Cancer

Keywords

Robot-Assisted Radical Prostatectomy; RARP; Preoperative Breathing Exercise; Deep Breathing Exercise; Postoperative Delirium; 4AT; Nu-DESC; Pneumoperitoneum

Outcome Measures

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.

  From the end of surgery through 48 hours postoperatively

Secondary Outcomes (5)

• 4AT Delirium Screening Score

  At 24 and 48 hours postoperatively

• Nursing Delirium Screening Scale (Nu-DESC) Score

  During the first 12 postoperative hours and during the 24-48-hour postoperative period

• Peripheral Oxygen Saturation (SpO₂) at Predefined Postoperative Time Points

  PACU/early postoperative period and at 6, 24, and 48 hours postoperatively

• Number of Participants Requiring Supplemental Oxygen Postoperatively

  From the PACU/early postoperative period through 48 hours postoperatively

• Postoperative Pain Score on the NRS/VAS

  PACU/early postoperative period and at 6, 24, and 48 hours postoperatively

Study Arms (2)

Preoperative Breathing Exercise Training

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants randomized to this arm will receive routine preoperative information and standard perioperative care without additional structured preoperative breathing exercise training.

Interventions

Preoperative Deep Breathing Exercise Training BEHAVIORAL

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.

Preoperative Breathing Exercise Training

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALİ DEMİRTAŞ: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Akdeniz University Hospital

Antalya, Antalya, (532) 256-8442, Turkey (Türkiye)

Location

Related Publications (3)

• Gaudreau 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 BACKGROUND

• Bellelli 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 BACKGROUND

• Inouye 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 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Prostatic Neoplasms; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Central Study Contacts

ALİ DEMİRTAŞ, Lucterer

CONTACT

+905322568442; alidemirtas@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a preoperative breathing exercise training group or a control group receiving routine preoperative information. Group allocation will be performed using the sealed-envelope method. Sequentially numbered, opaque, sealed envelopes will be used to ensure allocation concealment and will be opened only after the participant has been enrolled in the study.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

TU (1)