NCT07843602

Brief Summary

Transurethral resection (TUR) is a common minimally invasive surgical procedure for lower urinary tract diseases. However, postoperative urinary catheterization often causes catheter-related bladder discomfort (CRBD) and pain due to bladder spasms, which negatively impact recovery and sleep quality. Pharmacological agents used to alleviate CRBD and pain may cause adverse side effects. This study aims to evaluate the effects of cyclic sighing breathing exercises on CRBD severity, pain intensity, and sleep quality in patients undergoing TUR.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Oct 2027

First Submitted

Initial submission to the registry

September 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Sleep qualityTransurethral resectionBreathing exercisespainUrinary catheterization

Outcome Measures

Primary Outcomes (1)

  • Catheter-Related Bladder Discomfort (CRBD) Severity Score

    Catheter-related bladder discomfort severity is assessed using the 4-point rating scale developed by Agarwal et al. The scale classifies discomfort as: 0 = none; 1 = mild (reported by the patient only upon direct questioning); 2 = moderate (reported spontaneously by the patient without being asked, but not accompanied by behavioral responses); and 3 = severe (reported spontaneously and accompanied by behavioral manifestations such as vocal complaints, restless limb movements, or attempting to pull out the urinary catheter). Higher scores indicate greater severity of bladder discomfort.

    Measured at the 1st, 2nd, 6th, 12th, and 24th postoperative hours

Secondary Outcomes (2)

  • Postoperative Pain Intensity Score

    Measured at the 1st, 2nd, 6th, 12th, and 24th postoperative hours.

  • Postoperative Sleep Quality Score

    On the morning of postoperative day 1 (upon awakening)

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in this arm will receive preoperative training on the cyclic sighing breathing exercise technique from the researcher upon clinical admission. Following transurethral resection (TUR) surgery, participants will perform cyclic sighing breathing exercises under researcher supervision at the 1st, 2nd, 6th, 12th, and 24th postoperative hours. Each exercise session will last for 5 minutes and consists of taking a deep breath in through the nose, followed immediately by a second short breath to fully inflate the lungs, and then exhaling slowly and fully through the mouth. In addition to the breathing intervention, patients will receive standard postoperative clinical nursing care.

Other: Cyclic Sighing Breathing Exercise

Control Group

NO INTERVENTION

Patients in this arm will receive routine standard postoperative nursing care and physician-prescribed clinical treatments (such as standard continuous bladder irrigation and routine analgesic or antispasmodic medications as needed) without any structured breathing exercise education or intervention.

Interventions

The cyclic sighing intervention consists of structured breathing sessions taught preoperatively and supervised postoperatively. The patient assumes a comfortable supine or semi-Fowler position in bed. The exercise involves taking a slow, deep inhalation through the nose, immediately followed by a second short nasal inhalation to achieve maximum lung expansion, and then slowly and fully exhaling through the mouth, ensuring that exhalation lasts longer than inhalation. Patients perform this cycle continuously for 5 minutes at the 1st, 2nd, 6th, 12th, and 24th postoperative hours under researcher supervision. To protect nocturnal sleep patterns, sessions scheduled after 22:00 will be completed by 22:00.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Undergoing Transurethral Resection of the Prostate (TUR-P) or Transurethral Resection of Bladder Tumor (TUR-M/TUR-BT)
  • Having an indwelling urethral catheter placed postoperatively
  • Fully conscious, oriented, and cooperative
  • Able to speak and understand Turkish
  • Volunteering to participate and providing written informed consent

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical status score of IV or higher
  • Presence of any medical condition or physical impairment that prevents performing breathing exercises
  • Diagnosed history of sleep apnea
  • Regular use of sedative, hypnotic, or sleep-inducing medications
  • Neurological or psychiatric disorders severely impeding hearing, vision, or verbal communication
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Iskenderun State Hospital

Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (8)

  • Li C, Liu Z, Yang F. Predictors of catheter-related bladder discomfort after urological surgery. J Huazhong Univ Sci Technolog Med Sci. 2014 Aug;34(4):559-562. doi: 10.1007/s11596-014-1315-z. Epub 2014 Aug 19.

  • Markopoulos T, Katsimperis S, Lazarou L, Tzelves L, Mitsogiannis I, Papatsoris A, Skolarikos A, Varkarakis I. Catheter-Related Bladder Discomfort: Insights Into Pathophysiology, Clinical Impact, and Management. Cureus. 2025 Mar 27;17(3):e81322. doi: 10.7759/cureus.81322. eCollection 2025 Mar.

  • Mitobe Y, Yoshioka T, Baba Y, Yamaguchi Y, Nakagawa K, Itou T, Kurahashi K. Predictors of Catheter-Related Bladder Discomfort After Surgery: A Literature Review. J Clin Med Res. 2023 Apr;15(4):208-215. doi: 10.14740/jocmr4873. Epub 2023 Apr 28.

  • Etezadi F, Sajedi Y, Khajavi MR, Moharari RS, Amirjamshidi A. Preemptive Effect of Intraurethral Instillation of Ketamine-lidocaine Gel on Postoperative Catheter-related Bladder Discomfort after Lumbar Spine Surgery. Asian J Neurosurg. 2018 Oct-Dec;13(4):1057-1060. doi: 10.4103/ajns.AJNS_314_17.

  • Ghorbani A, Hajizadeh F, Sheykhi MR, Mohammad Poor Asl A. The Effects of Deep-Breathing Exercises on Postoperative Sleep Duration and Quality in Patients Undergoing Coronary Artery Bypass Graft (CABG): a Randomized Clinical Trial. J Caring Sci. 2018 Dec 1;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.

  • Hu B, Li C, Pan M, Zhong M, Cao Y, Zhang N, Yuan H, Duan H. Strategies for the prevention of catheter-related bladder discomfort: A PRISMA-compliant systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2016 Sep;95(37):e4859. doi: 10.1097/MD.0000000000004859.

  • Agarwal A, Raza M, Singhal V, Dhiraaj S, Kapoor R, Srivastava A, Gupta D, Singh PK, Pandey CK, Singh U. The efficacy of tolterodine for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Anesth Analg. 2005 Oct;101(4):1065-1067. doi: 10.1213/01.ane.0000167775.46192.e9.

  • Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPain

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gülay Altun Uğraş

    Mersin University

    STUDY DIRECTOR

Central Study Contacts

Hasan Şeren

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the behavioral nature of the cyclic sighing breathing exercise, participants, ward clinical care providers, and the field investigator who provides the instruction and collects measurements cannot be masked. However, allocation concealment is strictly maintained using sequentially numbered, sealed, opaque envelopes. Additionally, an independent biostatistician who is completely blinded to group allocations (Group A and Group B) will perform data entry, computerized processing, and final statistical outcome evaluations.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is designed as a prospective, two-arm, parallel-group randomized controlled clinical trial with a 1:1 allocation ratio. Eligible participants undergoing transurethral resection (TUR) will be assigned to either the experimental intervention group receiving cyclic sighing breathing exercises or the control group receiving standard postoperative nursing care. Allocation will be performed using a block randomization list created by an independent biostatistician, and allocation concealment will be ensured through sequentially numbered, sealed, opaque envelopes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, RN, PhD Student

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 28, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations