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Not yet recruiting NCT07319754

TENS for Pain and Sleep After Hernia Surgery

No phase Interventional Inguinal Hernia Postoperative Pain Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Electrical Nerve Stimulation (TENS), Standard Postoperative Care.
Who it may be relevant to
Registry conditions: Inguinal Hernia, Postoperative Pain, Sleep Disturbance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Sleep After Inguinal Hernia Surgery: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

  • Device Transcutaneous Electrical Nerve Stimulation (TENS)
    Physician-supervised application of TENS to the inguinal region after hernia surgery, following a standardized protocol.
  • Other Standard Postoperative Care
    Participants in this arm will receive routine postoperative care following inguinal hernia surgery, without TENS application.

Primary outcome measures

  • Postoperative Pain Intensity [Time frame: First 24 hours after surgery]
  • Change in Pain Intensity (VAS) [Time frame: First 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • Adults (≥18 years) undergoing elective inguinal hernia surgery

Ability to provide informed consent

Willingness to comply with study procedures

Exclusion criteria

  • History of epilepsy, cardiac pacemaker, or other contraindications to TENS

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Adana City Hospital — Adana

Identifiers

NCT: NCT07319754 · 22504254-050.04-NOHU · SAT 2025/15-BAGEP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗