Acute Postoperative PainNCT07732764
Transcutaneous Electrical Nerve Stimulation for Acute Postoperative Pain After Video-Assisted Thoracoscopic Surgery
A study testing Active TENS in people with Acute Postoperative Pain and Thoracic Surgical Procedures, run by Fooyin University at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Acute Postoperative Pain, Thoracic Surgical Procedures
- What is being tested?
- Active TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Aug 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Yuan's General Hospital
Kaohsiung City, Kaohsiung City, 806
JIA-XIN LIN, NP, +886972091276, candy640930@gmail.com
About this study
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
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.
- Being tested
- Active TENS, Sham TENS
- Keywords
- Sleep Quality, Quality of Life, Video-Assisted Thoracoscopic Surgery (VATS), Transcutaneous Electrical Nerve Stimulation (TENS), Acute Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TENSDevice
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 TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Preoperative baseline; 24 hours after initiation of the intervention; 72 hours after initiation of the intervention; and on the day of hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start28 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either an active TENS group or a sham TENS group in a parallel-group design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Fang Yeh, phD, Study chair, Fooyin UniversityJIA-XIN LIN, NP, Principal investigator, Fooyin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732764
- Sponsor's protocol ID
- YGHIRB-20250728B
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected during this study will not be made publicly available. There is no current plan to share de-identified individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07732764
- Acronym / sponsor ID
- YGHIRB-20250728B
- Keywords
- Sleep Quality, Quality of Life, Video-Assisted Thoracoscopic Surgery (VATS), Transcutaneous Electrical Nerve Stimulation (TENS), Acute Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either an active TENS group or a sham TENS group in a parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Experimental | Device: 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 TENS | Sham comparator | Device: 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 |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TENSActive 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 | Active TENS |
| Sham TENSSham 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. | Device | Sham TENS |
Primary outcome
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during this study will not be made publicly available. There is no current plan to share de-identified individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Fang Yeh, phD study chair
Fooyin University
JIA-XIN LIN, NP principal investigator
Fooyin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TENS in people with Acute Postoperative Pain and Thoracic Surgical Procedures, run by Fooyin University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIA-XIN LIN, NP (+886972091276, candy640930@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.