Gallstone DiseaseTENS-LCNCT07307703
TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Gallstone Disease and Postoperative Pain, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) can improve recovery for patients undergoing laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone Disease, Postoperative Pain, Surgical Anxiety
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- 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
- 1 Dec 2025to 30 Sep 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 aged 18-65 years scheduled for elective laparoscopic cholecystectomy
- ASA (American Society of Anesthesiologists) physical status classification I-II
- Ability to understand the study procedures and provide written informed consent
- No contraindications to TENS application (e.g., intact skin at electrode placement sites)
- Willingness to comply with perioperative assessments (pain, anxiety, satisfaction scales)
Who cannot join
- Patients with ASA III or higher physical status
- Presence of cardiac pacemaker or other implanted electrical devices
- History of epilepsy, severe neuropathy, or psychiatric disorders affecting pain/anxiety perception
- Skin lesions, infections, or dermatological conditions at electrode placement sites
- Use of analgesics, anxiolytics, or sedatives beyond standard perioperative protocols
- Emergency cholecystectomy or conversion to open surgery
- Pregnant or breastfeeding women
- Patients unwilling or unable to provide informed consent
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, 1 recruiting
- Recruiting
Adana City Hospital
Niğde, Adana, 51100
Abdurrahman acar, +905415298930, a.car7272@hotmail.com
Kezban Koraş SÖZEN, Associate Professor, +90, 0543 805 62 09, kezbankoras@ohu.edu.tr
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Surgical Anxiety, Postoperative Pain, and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy
This study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) can improve recovery for patients undergoing laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). TENS is a non-invasive method that uses mild electrical currents applied through the skin to stimulate nerves.
The main goals of the study are to determine if TENS can:
Read more
Reduce surgical anxiety before and during the procedure
Decrease postoperative pain after surgery
Improve overall patient satisfaction with their surgical experience
Patients who participate will receive standard surgical care, and some will also receive TENS therapy. Outcomes will be measured using patient questionnaires and clinical assessments during the hospital stay and follow-up period.
By comparing patients who receive TENS with those who do not, the study aims to provide evidence on whether this simple technique can enhance comfort and recovery after gallbladder surgery.
Read the detailed description
Gallstone disease is common in Western countries, and cholecystectomy is a routine abdominal surgical procedure. The laparoscopic approach is considered the gold standard. However, many patients experience acute postoperative pain, often reported as moderate to severe. Acute pain delays recovery and may lead to complications.
Opioids remain the cornerstone of postoperative pain management, but they are associated with adverse effects such as sedation, nausea, respiratory depression, and opioid-induced hyperalgesia. In addition, long-term problematic opioid use has been reported in 6-8% of patients after surgery. Therefore, non-pharmacological alternatives for postoperative pain relief are urgently needed.
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive intervention that delivers electrical currents through electrodes placed on intact skin. Evidence from systematic reviews and meta-analyses suggests that TENS is effective and safe for managing both acute and chronic pain, with minimal side effects and low cost. Patients may experience mild tingling or discomfort, and rarely skin irritation.
Despite promising data, few studies have evaluated the combined effects of TENS on surgical anxiety, postoperative pain, and patient satisfaction in laparoscopic cholecystectomy. Most prior research has focused only on pain outcomes, neglecting psychological dimensions and patient-centered measures. This study aims to fill that gap by assessing whether TENS can reduce perioperative anxiety, improve pain control, and enhance satisfaction with surgical care.
This randomized controlled trial will be conducted at Adana City Training and Research Hospital between October 2025 and October 2026. Eligible patients undergoing elective laparoscopic cholecystectomy will be randomized into two groups: a TENS intervention group and a control group receiving standard care. The sample size was determined by power analysis, requiring 40 participants per group (total n=80).
Data collection will include:
Personal Information Form (demographics and baseline characteristics)
Visual Analog Scale (VAS) for pain intensity
Surgery-Specific Anxiety Scale (validated Turkish instrument)
Newcastle Satisfaction with Nursing Care Scale (validated Turkish version)
Exclusion criteria include emergency cholecystectomy, conversion to open surgery, presence of pacemakers or implanted devices, uncontrolled epilepsy, chronic opioid use, severe psychiatric or cognitive disorders, dermatological contraindications, or concurrent participation in another clinical trial.
The primary outcomes are surgical anxiety, postoperative pain, and patient satisfaction. Secondary outcomes include recovery parameters and adverse events.
Hypotheses:
Null hypothesis (H0): TENS has no effect on surgical anxiety, postoperative pain, or patient satisfaction in laparoscopic cholecystectomy.
Alternative hypothesis (H1): TENS reduces surgical anxiety and postoperative pain while increasing patient satisfaction.
- Conditions
- Gallstone Disease, Postoperative Pain, Surgical Anxiety, Patient Satisfaction After Laparoscopic Cholecystectomy
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Laparoscopic Cholecystectomy, Gallstone Disease, Surgical Anxiety, Postoperative Pain, Transcutaneous Electrical Nerve Stimulation (TENS)
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
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
Also called TENS Therapy, Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive device-based intervention that delivers mild electrical currents through electrodes placed on intact skin. In this study, TENS will be applied perioperatively to patients undergoing laparoscopic cholecystectomy. The stimulation sessions will be conducted before and after surgery, following standardized clinical parameters to ensure safety and reproducibility. The intervention is designed to evaluate its effects on surgical anxiety, postoperative pain intensity, and patient satisfaction compared with standard care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 TENS Group | Experimental | Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care for laparoscopic cholecystectomy. TENS will be applied using surface electrodes placed on intact skin before and after surgery. The stimulation parameters will follow established clinical guidelines to ensure safety and effectiveness. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Control Group | No intervention | Participants in this arm will receive standard perioperative care for laparoscopic cholecystectomy without Transcutaneous Electrical Nerve Stimulation (TENS). Usual surgical and nursing protocols will be followed according to hospital standards. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction, which will be compared with the intervention group to evaluate the added effect of TENS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.
Measured: Within the first 24 hours after surgery
Postoperative Pain Intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.
Measured: Within the 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 posted29 Dec 2025
- Study start1 Dec 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies 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
- This study uses a parallel assignment model. Participants undergoing elective laparoscopic cholecystectomy will be randomly assigned to one of two groups: Intervention group: Patients will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care. Control group: Patients will receive standard perioperative care without TENS.
- 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
- NCT07307703
- Sponsor's protocol ID
- 22504254-050.04Cholecystectomy
- Acronym
- TENS-LC
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a limited sample size and is conducted at a single institution. Ethical considerations and institutional policies restrict the sharing of raw patient-level data. Only aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Surgical Anxiety, Postoperative Pain, and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07307703
- Acronym / sponsor ID
- TENS-LC / 22504254-050.04Cholecystectomy
- Conditions
- Gallstone Disease, Postoperative Pain, Surgical Anxiety, Patient Satisfaction After Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, Gallstone Disease, Surgical Anxiety, Postoperative Pain, Transcutaneous Electrical Nerve Stimulation (TENS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Dec 2025 (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 is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) can improve recovery for patients undergoing laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). TENS is a non-invasive method that uses mild electrical currents applied through the skin to stimulate nerves.
The main goals of the study are to determine if TENS can:
Reduce surgical anxiety before and during the procedure
Decrease postoperative pain after surgery
Improve overall patient satisfaction with their surgical experience
Patients who participate will receive standard surgical care, and some will also receive TENS therapy. Outcomes will be measured using patient questionnaires and clinical assessments during the hospital stay and follow-up period.
By comparing patients who receive TENS with those who do not, the study aims to provide evidence on whether this simple technique can enhance comfort and recovery after gallbladder surgery.
Detailed description
Gallstone disease is common in Western countries, and cholecystectomy is a routine abdominal surgical procedure. The laparoscopic approach is considered the gold standard. However, many patients experience acute postoperative pain, often reported as moderate to severe. Acute pain delays recovery and may lead to complications.
Opioids remain the cornerstone of postoperative pain management, but they are associated with adverse effects such as sedation, nausea, respiratory depression, and opioid-induced hyperalgesia. In addition, long-term problematic opioid use has been reported in 6-8% of patients after surgery. Therefore, non-pharmacological alternatives for postoperative pain relief are urgently needed.
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive intervention that delivers electrical currents through electrodes placed on intact skin. Evidence from systematic reviews and meta-analyses suggests that TENS is effective and safe for managing both acute and chronic pain, with minimal side effects and low cost. Patients may experience mild tingling or discomfort, and rarely skin irritation.
Despite promising data, few studies have evaluated the combined effects of TENS on surgical anxiety, postoperative pain, and patient satisfaction in laparoscopic cholecystectomy. Most prior research has focused only on pain outcomes, neglecting psychological dimensions and patient-centered measures. This study aims to fill that gap by assessing whether TENS can reduce perioperative anxiety, improve pain control, and enhance satisfaction with surgical care.
This randomized controlled trial will be conducted at Adana City Training and Research Hospital between October 2025 and October 2026. Eligible patients undergoing elective laparoscopic cholecystectomy will be randomized into two groups: a TENS intervention group and a control group receiving standard care. The sample size was determined by power analysis, requiring 40 participants per group (total n=80).
Data collection will include:
Personal Information Form (demographics and baseline characteristics)
Visual Analog Scale (VAS) for pain intensity
Surgery-Specific Anxiety Scale (validated Turkish instrument)
Newcastle Satisfaction with Nursing Care Scale (validated Turkish version)
Exclusion criteria include emergency cholecystectomy, conversion to open surgery, presence of pacemakers or implanted devices, uncontrolled epilepsy, chronic opioid use, severe psychiatric or cognitive disorders, dermatological contraindications, or concurrent participation in another clinical trial.
The primary outcomes are surgical anxiety, postoperative pain, and patient satisfaction. Secondary outcomes include recovery parameters and adverse events.
Hypotheses:
Null hypothesis (H0): TENS has no effect on surgical anxiety, postoperative pain, or patient satisfaction in laparoscopic cholecystectomy.
Alternative hypothesis (H1): TENS reduces surgical anxiety and postoperative pain while increasing patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model. Participants undergoing elective laparoscopic cholecystectomy will be randomly assigned to one of two groups: Intervention group: Patients will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care. Control group: Patients will receive standard perioperative care without TENS.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 TENS Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care for laparoscopic cholecystectomy. TENS will be applied using surface electrodes placed on intact skin before and after surgery. The stimulation parameters will follow established clinical guidelines to ensure safety and effectiveness. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction. |
| Control Group | No intervention | –Participants in this arm will receive standard perioperative care for laparoscopic cholecystectomy without Transcutaneous Electrical Nerve Stimulation (TENS). Usual surgical and nursing protocols will be followed according to hospital standards. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction, which will be compared with the intervention group to evaluate the added effect of TENS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years scheduled for elective laparoscopic cholecystectomy
- ASA (American Society of Anesthesiologists) physical status classification I-II
- Ability to understand the study procedures and provide written informed consent
- No contraindications to TENS application (e.g., intact skin at electrode placement sites)
- Willingness to comply with perioperative assessments (pain, anxiety, satisfaction scales)
Key exclusion criteria (8 listed)
- Patients with ASA III or higher physical status
- Presence of cardiac pacemaker or other implanted electrical devices
- History of epilepsy, severe neuropathy, or psychiatric disorders affecting pain/anxiety perception
- Skin lesions, infections, or dermatological conditions at electrode placement sites
- Use of analgesics, anxiolytics, or sedatives beyond standard perioperative protocols
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)Also: TENS Therapy, Electrical Nerve StimulationTranscutaneous Electrical Nerve Stimulation (TENS) is a non-invasive device-based intervention that delivers mild electrical currents through electrodes placed on intact skin. In this study, TENS will be applied perioperatively to patients undergoing laparoscopic cholecystectomy. The stimulation sessions will be conducted before and after surgery, following standardized clinical parameters to ensure safety and reproducibility. The intervention is designed to evaluate its effects on surgical anxiety, postoperative pain intensity, and patient satisfaction compared with standard care. | Device | Arm 1 TENS Group |
Primary outcome
Postoperative Pain Intensity (VAS)
Time frame: Within the first 24 hours after surgery
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.
Postoperative Pain Intensity
Time frame: Within the first 24 hours after surgery
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.
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 29 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a limited sample size and is conducted at a single institution. Ethical considerations and institutional policies restrict the sharing of raw patient-level data. Only aggregated results will be reported in publications.
Related trials for Gallstone Disease
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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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) in people with Gallstone Disease 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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 (VAS) (time frame: Within the 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 29 Dec 2025.