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Transurethral Resection of Bladder TumorNCT07843602

Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR

A study testing Cyclic Sighing Breathing Exercise in people with Transurethral Resection of Bladder Tumor and Transurethral Resection of the Prostate (TURP), run by Mersin University at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cyclic Sighing Breathing Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesTurkey (Türkiye)
Study dates
5 Nov 2026to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hasan Şeren contact

Turkey (Türkiye)2 sites, 2 recruiting
  • Hatay Iskenderun State Hospital

    Hatay, 31000

    Hasan Şeren, +90326 615 37 50, hasanseren94@gmail.com

    Hasan Şeren

    Not yet recruiting
  • Iskenderun State Hospital

    Hatay

    hasan seren, 05076413720, hasanseren94@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Cyclic Sighing Breathing Exercise on Catheter-Related Bladder Discomfort, Pain, and Sleep Quality in Patients Undergoing Transurethral Resection: A Randomized Controlled Trial

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.

Read the detailed description

This prospective, two-arm, parallel-group, randomized controlled clinical trial will be conducted in the Urology Ward of Hatay İskenderun State Hospital. A total of 76 patients scheduled for TUR (TUR-P or TUR-B/TUR-M) will be allocated into either the intervention group (n=38) or the control group (n=38) using block randomization with sealed opaque envelopes. The intervention group will receive pre-operative training on cyclic sighing breathing exercise. Postoperatively, participants in this group will perform cyclic sighing (two deep nasal inhalations followed by prolonged oral exhalation) for 5 minutes at the 1st, 2nd, 6th, 12th, and 24th postoperative hours under researcher supervision (completed before 22:00 to avoid nocturnal sleep disruption). The control group will receive routine standard postoperative nursing care. CRBD severity and pain intensity will be assessed at the 1st, 2nd, 6th, 12th, and 24th postoperative hours. Sleep quality will be evaluated on the morning of the first postoperative day (after awakening).

Being tested
Cyclic Sighing Breathing Exercise
Keywords
Sleep quality, Transurethral resection, Breathing exercises, pain, Urinary catheterization
Medical subject headings
Sleep Initiation and Maintenance Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclic Sighing Breathing ExerciseOther

    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.

Study groups in NCT07843602
Study groupRoleWhat they receive
Experimental groupExperimentalPatients 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.
Receives: Other: Cyclic Sighing Breathing Exercise
Control GroupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)
  1. Postoperative Pain Intensity Score

    Postoperative pain is assessed using the Numeric Rating Scale (NRS). Patients rate their perceived pain intensity on an 11-point scale from 0 to 10, where 0 represents "no pain" and 10 represents the "worst possible pain". Higher scores reflect higher pain intensity. In addition, total analgesic consumption and medication types will be recorded during the first 24 postoperative hours.

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

  2. Postoperative Sleep Quality Score

    Sleep quality is assessed using the Richard-Campbell Sleep Questionnaire (RCSQ). The instrument evaluates 5 domains (sleep depth, sleep latency, awakenings, time spent awake, and overall sleep quality) using a 0-100 mm Visual Analog Scale (VAS). Total scores range from 0 to 100, with higher scores indicating superior sleep quality (scores >50 denote good sleep quality).

    Measured: On the morning of postoperative day 1 (upon awakening)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2026
  2. Study start5 Nov 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07843602
Sponsor's protocol ID
HS-MU-001
Status last verified
Nov 2026
First submitted
21 Sep 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25135727
  • 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.

    PubMed 40291191
  • 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.

    PubMed 37187710
  • 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.

    PubMed 30459867
  • 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.

    PubMed 31915624
  • 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.

    PubMed 27631249
  • 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.

    PubMed 16192522
  • 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.

    PubMed 36630953

Questions about this trial

What is this clinical trial studying?

A study testing Cyclic Sighing Breathing Exercise in people with Transurethral Resection of Bladder Tumor and Transurethral Resection of the Prostate (TURP), run by Mersin University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hasan Şeren (+903266153750 ext. 1237, hasanseren94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Catheter-Related Bladder Discomfort (CRBD) Severity Score (time frame: Measured at the 1st, 2nd, 6th, 12th, and 24th postoperative hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07843602, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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