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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Catheter-Related Bladder Discomfort (CRBD) Severity Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 其他
- 盲法
- 单盲 (结局评估者)
盲法说明
Due to the behavioral nature of the cyclic sighing breathing exercise, participants, ward clinical care providers, and the field investigator who provides the instruction and collects measurements cannot be masked. However, allocation concealment is strictly maintained using sequentially numbered, sealed, opaque envelopes. Additionally, an independent biostatistician who is completely blinded to group allocations (Group A and Group B) will perform data entry, computerized processing, and final statistical outcome evaluations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- 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
研究组 & 干预措施
Experimental group
Patients 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.
干预措施: Cyclic Sighing Breathing Exercise (Other)
Control Group
Patients 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.
结局指标
主要结局
Catheter-Related Bladder Discomfort (CRBD) Severity Score
时间窗: Measured at the 1st, 2nd, 6th, 12th, and 24th postoperative hours
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.
次要结局
- Postoperative Pain Intensity Score(Measured at the 1st, 2nd, 6th, 12th, and 24th postoperative hours.)
- Postoperative Sleep Quality Score(On the morning of postoperative day 1 (upon awakening))
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07843602
- 其他研究编号
- HS-MU-001
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (5个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否