TENS for Pain and Sleep After Hernia Surgery

NCT07319754 | Not Yet Recruiting

• 2 other identifiers: 22504254-050.04-NOHUSAT 2025/15-BAGEP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Postoperative Pain; Sleep Disturbance

Keywords

Inguinal hernia; Postoperative Pain; Sleep Disturbance; Transcutaneous Electrical Nerve Stimulation (TENS)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Other: Standard Postoperative Care

Interventions

Standard Postoperative Care OTHER

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

Arm 2: Standard Care Group

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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

Arm 1 (Experimental): TENS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Adana City Hospital

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Parasomnias

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Kezban Koraş SÖZEN, Associate Professor

CONTACT

+90-0543 805 62 09; kezbankoras@ohu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Faculty of Health Sciences, Niğde Ömer Halisdemir University

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 6, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)