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临床试验/NCT07319754
NCT07319754尚未招募不适用

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

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Postoperative Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥18 years) undergoing elective inguinal hernia surgery
  • Ability to provide informed consent
  • Willingness to comply with study procedures

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

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.

干预措施: Standard Postoperative Care (Other)

结局指标

主要结局

Postoperative Pain Intensity

时间窗: First 24 hours after surgery

Pain intensity will be measured using the Visual Analog Scale (VAS) at 6, 12, and 24 hours postoperatively.

Change in Pain Intensity (VAS)

时间窗: First 24 hours after surgery

Pain intensity will be measured using the Visual Analog Scale (VAS) at 6, 12, and 24 hours postoperatively.

次要结局

未报告次要终点

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdurrahman Acar

Research Assistant, Faculty of Health Sciences, Niğde Ömer Halisdemir University

Nigde Omer Halisdemir University

研究点 (1)

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