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
| Registry | NCT07732764 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | Fooyin University (Other) |
| Conditions | Acute Postoperative Pain, Thoracic Surgical Procedures |
| Interventions | Active TENS, Sham TENS (Device) |
| Dates | start 2025-08-28, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-07-29, last updated 2026-07-29 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Postoperative Pain All trials for Thoracic Surgical Procedures All trials of Active TENS All trials of Sham TENS
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active TENS | Experimental | Device: Active TENS | Participants receive active transcutaneous electrical nerve stimulation (TENS) in addition to standard postoperative care. TENS is applied around the surgical site using four electrodes at 100 Hz and a pulse width of 200 microseconds for 30 minutes twice daily for three consecutive days. |
| Sham TENS | Sham comparator | Device: Sham TENS | Participants receive sham transcutaneous electrical nerve stimulation (TENS) using identical electrode placement and treatment procedures as the active TENS group, but without therapeutic electrical stimulation. Sessions last 30 minutes twice daily for three consecutive days |
Sex: All, ages: 15 Years to 85 Years
Inclusion Criteria * 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. Exclusion Criteria * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Yuan's General Hospital | Kaohsiung City, Kaohsiung City | Taiwan | Recruiting |