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Recruiting NCT07732764

Transcutaneous Electrical Nerve Stimulation for Acute Postoperative Pain After Video-Assisted Thoracoscopic Surgery

No phase Interventional Acute Postoperative Pain Thoracic Surgical Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active TENS, Sham TENS.
Who it may be relevant to
Registry conditions: Acute Postoperative Pain, Thoracic Surgical Procedures. Basic parameters: 15 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Active TENS
    Active transcutaneous electrical nerve stimulation (TENS) is administered in addition to standard postoperative care. Four electrodes are placed around the surgical site. Electrical stimulation is delivered at a frequency of 100 Hz with a pulse width of 200 microseconds for 30 minutes per session, twice daily for three consecutive days. The stimulation intensity is adjusted to the highest level tolerated without discomfort.
  • Device Sham TENS
    Sham transcutaneous electrical nerve stimulation (TENS) uses identical electrode placement and treatment procedures as the active TENS intervention but delivers no therapeutic electrical stimulation. Participants continue to receive standard postoperative care.

Primary outcome measures

  • Pain intensity (Numeric Rating Scale, NRS) [Time frame: Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.]
Secondary outcome measures (2)
  • Sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ) [Time frame: 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) [Time frame: Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Yuan's General Hospital — Kaohsiung City

Identifiers

NCT: NCT07732764 · YGHIRB-20250728B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗