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Inguinal HerniaTENS-HERNIANCT07319754

TENS for Pain and Sleep After Hernia Surgery

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Standard Postoperative Care in people with Inguinal Hernia and Postoperative Pain, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcutaneous Electrical Nerve Stimulation (TENS) and Standard Postoperative Care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jan 2026to 10 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kezban Koraş SÖZEN, Associate Professor contact

+90-0543 805 62 09

kezbankoras@ohu.edu.tr

Turkey (Türkiye)1 site
  • Adana City Hospital

    Adana

    Abdurrahman ACAR, RN, MSc, +90, 0541 529 89 30, aacar@ohu.edu.tr

    Kezban Koraş SÖZEN, Associate Professor, +90, 0543 805 62 09, kezbankoras@ohu.edu.tr

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Transcutaneous Electrical Nerve Stimulation (TENS), Standard Postoperative Care
Keywords
Inguinal hernia, Postoperative Pain, Sleep Disturbance, Transcutaneous Electrical Nerve Stimulation (TENS)
Medical subject headings
Hernia, Inguinal, Pain, Postoperative, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Electrical Nerve Stimulation (TENS)Device

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

  • Standard Postoperative CareOther

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

Study groups in NCT07319754
Study groupRoleWhat they receive
Arm 1 (Experimental): TENS GroupExperimentalParticipants 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.
Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Arm 2: Standard Care GroupActive comparatorParticipants 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.
Receives: Other: Standard Postoperative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity

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

    Measured: First 24 hours after surgery

  2. Change in Pain Intensity (VAS)

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

    Measured: First 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start10 Jan 2026 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion10 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319754
Sponsor's protocol ID
22504254-050.04-NOHU
Other IDs
SAT 2025/15-BAGEP
Acronym
TENS-HERNIA
Status last verified
Dec 2025
First submitted
10 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Standard Postoperative Care in people with Inguinal Hernia and Postoperative Pain, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kezban Koraş SÖZEN, Associate Professor (+90-0543 805 62 09, kezbankoras@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity (time frame: First 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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