Transcutaneous Electrical Nerve Stimulation for Acute Postoperative Pain After Video-Assisted Thoracoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-85
SponsorFooyin University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active TENS
DeviceActive 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
DeviceSham 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Active TENSExperimental treatment 1 intervention
Group B: Sham TENSSham comparator 1 intervention
Trial outcomes
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.
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 outcomes
1
Sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ)
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.
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.2
Health-related quality of life (PROMIS Global Health Scale)
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov