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

NCT07732764 | Recruiting

• 1 other identifier: YGHIRB-20250728B
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Postoperative Pain; Thoracic Surgical Procedures

Keywords

Sleep Quality; Quality of Life; Video-Assisted Thoracoscopic Surgery (VATS); Transcutaneous Electrical Nerve Stimulation (TENS); Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity (Numeric Rating Scale, NRS)

  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.

  Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Active TENS

EXPERIMENTAL

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.

Device: Active TENS

Sham TENS

SHAM COMPARATOR

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

Device: Sham TENS

Interventions

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.

Active TENS

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.

Sham TENS

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Yuan's General Hospital

Kaohsiung City, Kaohsiung City, 806, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hui-Fang Yeh, phD

  Fooyin University

  STUDY CHAIR

• JIA-XIN LIN, NP

  Fooyin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIA-XIN LIN, NP

CONTACT

+886972091276; candy640930@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either an active TENS group or a sham TENS group in a parallel-group design

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 29, 2026
• Study Start: August 28, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)