NCT07457086

Brief Summary

The aim of this study was to determine the effects of the 4-7-8 breathing technique on sleep quality, pain, and recovery quality in patients undergoing transurethral resection of the bladder (TUR-B). The population of the study will consist of patients who undergo TUR-B in the urology clinics of Tarsus State Hospital. In determining the sample size, the number of samples calculated based on the pain variable in reference studies was minimal; therefore, an effect size of 0.80, considered the upper limit, was taken as the basis. Using a power level of 90% and a two-tailed significance level (1-α), the calculation performed with G\*Power (version 3.1) resulted in a minimum total sample size of 68 patients, with 34 patients in each group (study group = 34; control group = 34). Data in the study will be collected using the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," "Quality of Recovery-15 Scale," and "Visual Analog Scale." When the researchers visit the patient, they will first provide the "Informed Consent Form" and then have the patient complete the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," and "Quality of Recovery-15 Scale." The researcher will then learn from another researcher (MB), who will not be involved in data collection, which group the patient belongs to. Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. The control group will receive the routine postoperative procedures and care in the clinic. All patients will be assessed with the "Richard Campbell Sleep Questionnaire" and "Quality of Recovery-15 Scale" at the 24th hour postoperatively, and with the "Visual Analog Scale" at the 4th, 8th, 12th, and 24th postoperative hours.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Sleep QualityPainNursingQuality of Recovery

Outcome Measures

Primary Outcomes (3)

  • Sleep

    Richard Campbell Sleep Questionnaire: This questionnaire is designed to assess various dimensions of an individual's nocturnal sleep, including sleep depth, sleep latency, number of awakenings during the night, duration of wakefulness after nocturnal awakenings, overall sleep quality, and environmental noise level. T. Each item is evaluated using a visual analog scale ranging from 0 to 100. When calculating the total score, only the first five items are considered, while the sixth item, which assesses environmental noise, is excluded from the evaluation. Scores between 0 and 25 indicate very poor sleep, whereas scores between 76 and 100 indicate very good sleep. Higher scores are interpreted as reflecting better sleep quality.

    6 months

  • Quality of Recovery

    Quality of Recovery-15 (QoR-15) Scale: Aimed at assessing recovery quality and overall well-being, this instrument uses a visual analog scale for evaluation. The scale consists of 15 items and includes two subdimensions. Each item is marked on a horizontal line 10 cm in length, with each centimeter representing 1 point, resulting in item scores ranging from 0 to 10. During evaluation, positive statements are scored such that 0 corresponds to "never" and 10 to "always," while negative statements are reverse-scored, with 0 representing "always" and 10 representing "never." The total score of the scale ranges from 0 to 150, with higher scores indicating better recovery quality. The first subdimension assesses the patient's subjective feelings and emotions over the past 24 hour

    6 months

  • Pain Level

    This scale allows patients to evaluate their level of pain on a line ranging from 0 (no pain) to 10 (extremely severe pain). It will be used to assess the intensity of pain experienced by the patients.

    6 months

Study Arms (2)

Experimental: 4-7-8 breathing exercise group

EXPERIMENTAL

Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours.

Other: 4-7-8 breathing technique

Control group

NO INTERVENTION

The control group will receive the routine postoperative procedures and care in the clinic

Interventions

Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours.

Experimental: 4-7-8 breathing exercise group

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years and older,
  • Patients undergoing transurethral resection of the bladder (TUR-B),
  • Patients who are conscious, oriented, and cooperative,
  • Patients who provide written consent to participate in the study,
  • Patients who stay in the hospital for at least one night postoperatively,
  • Patients who speak and understand Turkish.

You may not qualify if:

  • Patients who do not wish to participate or who withdraw from the study,
  • Patients who develop complications during or after the surgical procedure,
  • Patients who are followed in the intensive care unit postoperatively,
  • Patients with chronic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Turkey, 33400, Turkey (Türkiye)

Location

Related Publications (5)

  • 8. Aktaş, G. K., & İlgin, V. E. (2023). The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obesity surgery, 33(3), 920-929. https://doi.org/10.1007/s11695-022-06405-1

    BACKGROUND
  • 7. Eskici İlgin, V., & Yayla, A. (2023). Effect of the 4-7-8 breathing technique on pain level and sleep quality of patients after laparoscopic bariatric surgery: A randomized controlled study. Bariatric Surgical Practice and Patient Care, 18(4), 225-232. https://doi.org/10.1089/bari.2022.0044

    BACKGROUND
  • 6. Eskimez, Z., Keskin, A., Kurt, E., Özbarlas, H. S., Tekin, M., & Kundakçı, B. (2026). 4-7-8 Breathing Techniques Make It Possible to Reduce Pain Associated With Total Knee Arthroplasty: A New Technique in Respiratory Exercises. Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses, 41(1), 48-53. https://doi.org/10.1016/j.jopan.2025.04.009

    BACKGROUND
  • 2. Özlü, Z. K. ve Özer, N. (2015). Richard-campbell uyku ölçeği geçerlilik ve güvenilirlik çalışması. Journal of Turkish Sleep Medicine, 2: 29-32.

    BACKGROUND
  • 3. Kara, U, Şimşek, F, Kamburoğlu, H, Özhan, M. Ö, Alakuş, Ü, İnce, M. E, Eksert, S, Özkan, G, Eşkin, M. B, & Şenkal, S (2022). Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turkish Journal of Medical Sciences 52 (2): 427-435. https://doi.org/10.55730/1300-0144.5330

    RESULT

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

  • Gamze Bozkul

    Tarsus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A total of 68 eligible patients will be randomly assigned to group A or B using a computer-generated randomization by an independent biostatistician. Group allocation (intervention vs. control) will be determined by coin toss. Assignment information will be placed in opaque envelopes and opened after obtaining informed consent. Participants cannot be blinded due to the 4-7-8 breathing intervention and post-TURB monitoring in shared rooms, but researchers will remain blinded to group allocation. Data will be analyzed by an independent biostatistician unaware of group assignments, ensuring blinding during analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study was planned as a randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

March 20, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations