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Идёт набор 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

Без фазы С лечением 4-7-8 Breathing Technique

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 4-7-8 breathing technique.
Кому может быть актуально
Состояния в реестре: 4-7-8 Breathing Technique. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 4-7-8 breathing technique
    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 superv

Первичные конечные точки

  • Sleep [Срок оценки: 6 months]
  • Quality of Recovery [Срок оценки: 6 months]
  • Pain Level [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Tarsus University — Mersin

Публикации

  • 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. PMID 36480101
  • 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
  • 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. PMID 40742342
  • 2. Özlü, Z. K. ve Özer, N. (2015). Richard-campbell uyku ölçeği geçerlilik ve güvenilirlik çalışması. Journal of Turkish Sleep Medicine, 2: 29-32.
  • 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. PMID 36161615

Идентификаторы

NCT: NCT07457086 · TU-BOZKUL-016

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗