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临床试验/NCT07457086
NCT07457086招募中不适用

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

Tarsus University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年3月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
68
试验地点
1
主要终点
Sleep

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Control group

No Intervention

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

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.

干预措施: 4-7-8 breathing technique (Other)

结局指标

主要结局

Sleep

时间窗: 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.

Quality of Recovery

时间窗: 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

Pain Level

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze BOZKUL

Assistant Professor

Tarsus University

研究点 (1)

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