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

NCT07732764 — Not applicable, Recruiting, 90 participants, Fooyin University

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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

RegistryNCT07732764
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment90 (Estimated)
SponsorFooyin University (Other)
ConditionsAcute Postoperative Pain, Thoracic Surgical Procedures
InterventionsActive TENS, Sham TENS (Device)
Datesstart 2025-08-28, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-07-29, last updated 2026-07-29
Locations1 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

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Active TENSExperimentalDevice: Active TENSParticipants 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 TENSSham comparatorDevice: Sham TENSParticipants 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
  • Active TENS (Device): 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.
  • Sham TENS (Device): 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.

+Outcome measures

Primary outcomes

  • Pain intensity (Numeric Rating Scale, NRS) [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.

Secondary outcomes

  • 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.]: Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated instrument that evaluates perceived sleep depth, sleep latency, number of awakenings, efficiency of returning to sleep, and overall sleep quality. The RCSQ consists of five items scored from 0 to 100, with higher scores indicating better sleep quality.
  • 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.]: Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, which evaluates participants' overall physical and mental health. Each domain (Global Physical Health and Global Mental Health) is calculated from four items, with scores ranging from 4 to 20. Higher scores indicate better health-related quality of life.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Yuan's General HospitalKaohsiung City, Kaohsiung CityTaiwanRecruiting

+Investigators

  • Hui-Fang Yeh, phD, Study chair, Fooyin University
  • JIA-XIN LIN, NP, Principal investigator, Fooyin University