- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457086
The Effects of the 4-7-8 Breathing Technique on Sleep Quality, Pain, and Recovery Outcomes in Patients Undergoing Transurethral Resection of the Bladder
The Effects of the 4-7-8 Breathing Technique on Sleep Quality, Pain, and Recovery Outcomes in Patients Undergoing Transurethral Resection of the Bladder:A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.The data will be analyzed using a computer. Descriptive characteristics of the patients will be summarized as mean ± standard deviation, median (minimum-maximum), percentage, and frequency values. Qualitative data will be categorized and converted into quantitative data, and presented as percentages and frequency distributions. After examining the normality of the data distribution, the independent samples t-test will be used to compare continuous variables that show a normal distribution between two independent groups. For continuous variables that do not follow a normal distribution, group comparisons will be performed using the Mann-Whitney U test. A p-value of <0.05 will be considered statistically significant, with a 95% confidence interval.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: GAMZE Bozkul, Dr
- Phone Number: +903246000033
- Email: gamze.bozkul@gmail.com
Study Contact Backup
- Name: ELİFNUR SAPMAZ
- Phone Number: 05345513700
- Email: gamze.bozkul@gmail.com
Study Locations
-
-
Turkey
-
Mersin, Turkey, Turkey (Türkiye), 33400
- Recruiting
- Tarsus University
-
Contact:
- Gamze Bozkul
- Phone Number: 03246000033
- Email: gamze.bozkul@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: 4-7-8 breathing exercise group
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.
|
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.
|
|
No Intervention: Control group
The control group will receive the routine postoperative procedures and care in the clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gamze Bozkul, Tarsus University
Publications and helpful links
General Publications
- Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.
- Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
- 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
- 2. Özlü, Z. K. ve Özer, N. (2015). Richard-campbell uyku ölçeği geçerlilik ve güvenilirlik çalışması. Journal of Turkish Sleep Medicine, 2: 29-32.
- Eskimez Z, Keskin A, Kurt E, Ozbarlas HS, Tekin M, Kundakci B. 4-7-8 Breathing Techniques Make It Possible to Reduce Pain Associated With Total Knee Arthroplasty: A New Technique in Respiratory Exercises. J Perianesth Nurs. 2026 Feb;41(1):48-53. doi: 10.1016/j.jopan.2025.04.009. Epub 2025 Jul 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TU-BOZKUL-016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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