Impact of Preoperative Yoga Intervention on Short term Perioperative Outcomes in Adult Smokers Undergoing TURBT Surgery A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This pilot randomized controlled trial with two parallel arms aims to assess the impact of preoperative yoga interventions as adjunctive therapies on perioperative pulmonary function, clinical outcomes, and psychological well-being in adult smokers undergoing TURBT surgery under general anaesthesia. Considering it a pilot study sample size was kept 60 and they will be randomized into two groups: an intervention group receiving yoga/pranayama sessions twice daily for 7 days preoperatively (and continued postoperatively after 48 hours until discharge), and a control group receiving standard preoperative care without yoga . Primary outcome will be the change in Forced Vital Capacity (FVC) from baseline to Day 3 postoperatively. Secondary outcomes include tidal volume, peak expiratory flow rate, breath-holding time, incidence of postoperative pulmonary complications, requirement of supplemental oxygen, ICU admission for any respiratory complications, patient reported psychological well being (SFQ, STAI scores), and inflammatory biomarker Neutrophil-to-Lymphocyte Ratio (NLR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •History of smoking: more than or equal to 1 pack-year exposure Smoking cessation for at least a week Scheduled for elective transurethral resection of bladder tumour (TURBT) surgery under general anaesthesia surgically resectable Carcinoma of urinary bladder Mild, Moderate, Severe chronic obstructive pulmonary disease (COPD) classified as GOLD Stage I, II, III respectively.
排除标准
- •Patient refusal or unwillingness to participate Very Severe COPD (GOLD Stage IV), home oxygen therapy requirement, or oxygen saturation less than 92 percentage on room air Uncontrolled cardiovascular conditions: recent MI (within 6 months), unstable angina, or decompensated heart failure Neuromuscular or orthopaedic limitations for yoga Severe cognitive impairment Major surgery in the past 3 months and Minor surgery within last 2 weeks Chronic or regular practitioners of yoga or pranayama.
研究者
Asim ghimire
All India Institute of Medical Sciences Rishikesh