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).
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
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain, Sleep Disturbance
- 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.
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
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.
- Conditions
- Inguinal Hernia, Postoperative Pain, Sleep Disturbance
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted6 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahman Acar, Nigde Omer Halisdemir University
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Sleep After Inguinal Hernia Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07319754
- Acronym / sponsor ID
- TENS-HERNIA / 22504254-050.04-NOHU
- Conditions
- Inguinal Hernia, Postoperative Pain, Sleep Disturbance
- Keywords
- Inguinal hernia, Postoperative Pain, Sleep Disturbance, Transcutaneous Electrical Nerve Stimulation (TENS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Experimental): TENS Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
| Arm 2: Standard Care Group | Active comparator | Other: Standard Postoperative CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) undergoing elective inguinal hernia surgery
- Ability to provide informed consent
- Willingness to comply with study procedures
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Physician-supervised application of TENS to the inguinal region after hernia surgery, following a standardized protocol. | Device | Arm 1 (Experimental): TENS Group |
| Standard Postoperative CareParticipants in this arm will receive routine postoperative care following inguinal hernia surgery, without TENS application. | Other | Arm 2: Standard Care Group |
Primary outcome
Postoperative Pain Intensity
Time frame: 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)
Time frame: First 24 hours after surgery
Pain intensity will be measured using the Visual Analog Scale (VAS) at 6, 12, and 24 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.