Acute Postoperative Pain, Thoracic Surgical Procedures
Conditions
Keywords
Sleep Quality, Quality of Life, Video-Assisted Thoracoscopic Surgery (VATS), Transcutaneous Electrical Nerve Stimulation (TENS), Acute Postoperative Pain
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.
Interventions
DEVICEActive 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.
DEVICESham 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.
Sponsors
Fooyin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomly assigned to either an active TENS group or a sham TENS group in a parallel-group design
Eligibility
Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
CONTACTJIA-XIN LIN, NP
STUDY_CHAIRHui-Fang Yeh, phD
Fooyin University
PRINCIPAL_INVESTIGATORJIA-XIN LIN, NP
Fooyin University
Outcome results
None listed