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| ID | Type | Description | Link |
|---|---|---|---|
| SAT 2025/15-BAGEP | Other Identifier | Niğde Ömer Halisdemir University Scientific Research Projects Coordination Unit |
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This study evaluates whether Transcutaneous Electrical Nerve Stimulation (TENS) improves postoperative pain and sleep quality in adults undergoing inguinal hernia surgery. After surgery, participants will receive physician-supervised TENS or usual care. Pain intensity and sleep quality will be measured and compared between groups to assess the effectiveness and safety of TENS as a supportive recovery method.
This randomized controlled clinical trial investigates the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on postoperative pain and sleep quality in patients undergoing inguinal hernia repair. Inguinal hernia is one of the most common surgical conditions worldwide, with increasing prevalence in recent years. Although tension-free herniorrhaphy has become the gold standard technique due to its low recurrence rate, rapid recovery, and cost-effectiveness, chronic postoperative inguinal pain (CPIP) remains a significant complication that negatively affects quality of life. CPIP is typically defined as new or altered groin pain persisting for more than three months after surgery, and its pathophysiology is not fully understood. Nerve injury or entrapment of the ilioinguinal, iliohypogastric, or genitofemoral nerves is considered a major contributor.
Postoperative pain management often relies on opioid analgesics, which carry risks of dependence, respiratory depression, and prolonged hospitalization. Therefore, non-pharmacological alternatives are of growing interest. TENS is a minimally invasive neuromodulation technique that modulates pain signals, most commonly explained by the Gate Control Theory, in which stimulation of large myelinated fibers inhibits transmission of pain through smaller nociceptive fibers. Previous studies have suggested potential benefits of TENS in CPIP, but evidence remains limited and inconsistent. Moreover, chronic pain is frequently associated with sleep disturbances, further impairing physical and psychological well-being. TENS may therefore improve both pain and sleep quality in this patient population.
The study will be conducted between October 2025 and October 2026 at the General Surgery Department of SBÜ Adana City Training and Research Hospital. Eligible participants will be adults (≥18 years) undergoing inguinal hernia surgery who are conscious, cooperative, and without contraindications to TENS. Exclusion criteria include cardiac pacemakers or implanted electronic devices, uncontrolled epilepsy or neurological disorders, chronic opioid use prior to surgery, severe psychiatric or cognitive impairment, dermatological conditions at electrode sites, requirement for additional analgesic/regional block during follow-up, or concurrent participation in another clinical trial.
Sample size was determined by power analysis, requiring 40 patients in the intervention group and 40 in the control group (total n=80) to detect a significant difference with α=0.05 and power=0.80. Data collection will include a Personal Information Form, the Visual Analog Scale (VAS) for pain intensity, and the Richards-Campbell Sleep Questionnaire (RCSQ) for sleep quality. VAS is a validated, simple, and widely used tool for assessing subjective pain intensity, while the RCSQ evaluates multiple dimensions of sleep quality using visual analog scales.
The primary hypothesis is that TENS will reduce postoperative pain and improve sleep quality compared with standard care. The null hypothesis states that TENS has no effect on these outcomes. Ethical approval has been obtained, and all procedures will be performed under physician supervision to ensure patient safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Experimental): TENS Group | Experimental | Participants in this arm will receive physician-supervised Transcutaneous Electrical Nerve Stimulation (TENS) following inguinal hernia surgery. TENS will be applied to the inguinal region using surface electrodes according to a standardized protocol. The intervention aims to reduce postoperative pain and improve sleep quality compared with standard care. |
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| Arm 2: Standard Care Group | Active Comparator | Participants in this arm will receive standard postoperative care following inguinal hernia surgery, without TENS application. Outcomes will be assessed in the same way as the experimental group for comparison. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Device | Physician-supervised application of TENS to the inguinal region after hernia surgery, following a standardized protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | Pain intensity will be measured using the Visual Analog Scale (VAS) at 6, 12, and 24 hours postoperatively. | First 24 hours after surgery |
| Change in Pain Intensity (VAS) | Pain intensity will be measured using the Visual Analog Scale (VAS) at 6, 12, and 24 hours postoperatively. | First 24 hours after surgery |
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Inclusion Criteria:
Ability to provide informed consent
Willingness to comply with study procedures
Exclusion Criteria:
Severe psychiatric or neurological disorders affecting pain or sleep assessment
Allergy or intolerance to electrode materials
Patients requiring emergency surgery
Inability to complete questionnaires (VAS, PSQI)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezban Koraş SÖZEN, Associate Professor | Contact | +90-0543 805 62 09 | kezbankoras@ohu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adana City Hospital | Adana | Turkey (Türkiye) |
Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Participants will be randomly assigned to one of two parallel groups. The intervention group will receive physician-supervised Transcutaneous Electrical Nerve Stimulation (TENS) following inguinal hernia surgery, while the control group will receive standard postoperative care without TENS. Outcomes will be compared between groups to evaluate the effect of TENS on postoperative pain and sleep quality.
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No additional parties are masked in this study. The trial is conducted as open label, and both participants and investigators are aware of group assignments.
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| Standard Postoperative Care | Other | Participants in this arm will receive routine postoperative care following inguinal hernia surgery, without TENS application. |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |