TENS for Pain and Sleep After Hernia Surgery

NCT ID: NCT07319754

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-10
• Study Completion Date: 2026-10-10

Brief Summary

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.

Conditions

Inguinal Hernia; Postoperative Pain; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 (Experimental): TENS Group

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.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: DEVICE

Physician-supervised application of TENS to the inguinal region after hernia surgery, following a standardized protocol.

Arm 2: Standard Care Group

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.

Group Type: ACTIVE_COMPARATOR

Standard Postoperative Care

Intervention Type: OTHER

Participants in this arm will receive routine postoperative care following inguinal hernia surgery, without TENS application.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)

Physician-supervised application of TENS to the inguinal region after hernia surgery, following a standardized protocol.

Intervention Type: DEVICE

Standard Postoperative Care

Participants in this arm will receive routine postoperative care following inguinal hernia surgery, without TENS application.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Abdurrahman Acar

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adana City Hospital

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Kezban Koraş SÖZEN, Associate Professor

Role: CONTACT

kezbankoras@ohu.edu.tr

+90-0543 805 62 09

Facility Contacts

Abdurrahman ACAR, RN, MSc

Role: primary

aacar@ohu.edu.tr

+90, 0541 529 89 30

Kezban Koraş SÖZEN, Associate Professor

Role: backup

kezbankoras@ohu.edu.tr

+90, 0543 805 62 09

Other Identifiers

SAT 2025/15-BAGEP

Identifier Type: OTHER

Identifier Source: secondary_id

22504254-050.04-NOHU

Identifier Type: -

Identifier Source: org_study_id