Effects of Transcutaneous Electrical Nerve Stimulation on Acute Postoperative Pain, Sleep Quality, and Quality of Life in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized, Double-Blind, Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain intensity (Numeric Rating Scale, NRS)
研究概览
简要总结
This randomized, double-blind, sham-controlled study aims to evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain, sleep quality, and quality of life in patients undergoing video-assisted thoracoscopic surgery (VATS). Participants will be randomly assigned to either an active TENS group or a sham TENS group. TENS treatment will be administered twice daily for 30 minutes over three consecutive days beginning 24 hours after surgery. Pain intensity, sleep quality, and quality of life will be assessed at predefined time points to determine the effectiveness of TENS as an adjunctive postoperative pain management strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants and outcome assessors are blinded to treatment assignment. Participants in the sham TENS group receive identical electrode placement and procedures without therapeutic electrical stimulation to maintain blinding.
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 15 to 85 years.
- •Participants younger than 18 years of age must have written informed consent provided by a parent or legal guardian.
- •Able to communicate and read/write in Chinese.
- •Scheduled to undergo video-assisted thoracoscopic surgery (VATS) as determined by the treating physician.
- •Have stable vital signs.
- •Willing to participate in the study and able to complete all study procedures.
排除标准
- •History of a bleeding disorder.
- •Patients undergoing emergency surgery.
- •Patients undergoing bilateral video-assisted thoracoscopic surgery (VATS).
- •History of cardiac disease, including cardiac arrhythmia or implantation of a cardiac pacemaker.
- •Known allergy or hypersensitivity to TENS electrodes or adhesive pads.
- •Cognitive impairment or inability to comply with the study procedures
结局指标
主要结局
Pain intensity (Numeric Rating Scale, NRS)
时间窗: Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
次要结局
- Sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ)(Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.)
- Health-related quality of life (PROMIS Global Health Scale)(Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.)