Cholecystitis; GallstoneTENSNCT05962853
Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy
A study testing Experimental group (Transcutaneous Electrical Nerve Stimulation) in people with Cholecystitis; Gallstone and Cholecystolithiasis, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve Stimulation) on patient outcomes after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis; Gallstone, Cholecystolithiasis
- What is being tested?
- Experimental group (Transcutaneous Electrical Nerve Stimulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Over 18 years old,
- Without pacemaker and arrhythmia,
- No previous history of chronic pain, alcohol or drug addiction,
- Not using TENS/opioids before surgery,
- Epidural analgesia is not applied in the postoperative period, without cognitive impairment,
- No thoracic incision other than cholecystectomy,
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- Having at least 1 drain
- No metastatic disease
- No need for mechanical ventilation
- As a result of the evaluation by the physician, there is no objection to the application of TENS,
- Who agree to participate in the study,
- No postoperative complications
- Patients with American Society of Anesthesiology (ASA) evaluation I, II, III will be included in the sample group.
Who cannot join
- refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, Yüreğir / Adana, 01220
About this study
Official title: Effect of Trans Electrical Nerve Stimulation on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study
The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve Stimulation) on patient outcomes after laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute cholecystitis and gallstone pancreatitis.Many complications can be seen after laparoscopic cholecystectomy.
The most common complication after laparoscopic cholecystectomy is pain. Pain appears as incisional, visceral and shoulder pain after laparoscopic cholecystectomy.After laparoscopic surgery, increased intra-abdominal pressure, stretching of the peritoneum, inability to take air given carbon dioxide (CO2), shoulder pain due to tension of muscle fibers due to diaphragm irritation, and visceral pain due to the interference of trocars on the abdominal wall as a result of intra-abdominal intervention are seen. After laparoscopic cholecystectomy, the effect of general anesthesia and the proximity of the incision area to the diaphragm may also cause pulmonary complications. Pneumoperiteneum developed by the administration of CO2 gas after laparoscopic cholecystectomy; Diaphragmatic irritation, increased intra-abdominal pressure, stretching of the peritoneum, and consequently the tension in the muscle fibers in the diaphragm can cause pain.
Inability to control pain can lead to many undesirable conditions in the patient, such as reluctance to mobilize, increased oxygen consumption, and delayed wound healing. This situation is also associated with increased hospital stay and financial burdens.In order to provide effective pain control, the combined use of pharmacological and non-pharmacological methods is important.Non-pharmacological methods are easy to learn, safe, have no definite contraindications, and provide pain management with non-drug applications. In a meta-analysis, it was determined that Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, safe non-pharmacological method for symptomatic relief of pain and discomfort and no serious side effects were observed.
Studies have shown that TENS application reduces postoperative pain level and analgesia consumption. In addition, TENS application after laparoscopic cholecystectomy was found to be associated with a decrease in postoperative pain severity and complaints of nausea and vomiting. It is seen that there are not enough resources in the literature regarding the application of TENS after laparoscopic cholecystectomy.
The aim of this study is to evaluate the effect of TENS on patient outcomes after laparoscopic cholecystectomy.
.
- Conditions
- Cholecystitis; Gallstone, Cholecystolithiasis
- Being tested
- Experimental group (Transcutaneous Electrical Nerve Stimulation)
- Keywords
- Pain, Cholecystectomy, Nurse, TENS
- Medical subject headings
- Cholecystitis, Gallstones, Cholecystolithiasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group (Transcutaneous Electrical Nerve Stimulation)Other
The application will be applied at 8 hour intervals in the first 24 hours after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group ( TENS will be applied ) | Experimental | After 30 minutes of TENS application 2 hours after the surgery, TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). TENS application hours will be arranged according to the patient in order to protect sleep integrity. Receives: Other: Experimental group (Transcutaneous Electrical Nerve Stimulation) |
| Control Group ( TENS will not be applied ) | No intervention | Application of the control group: TENS will not be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NRS)
The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.
Measured: 24 hours
Secondary outcomes (1)
American Pain Society Patient Outcome
American Pain Society Patient Outcome (APS-POQ) Questionnaire-Revised to measure pain management and patient satisfaction developed. (APS-POQ) is a tool designed to evaluate patients' experiences and satisfaction with pain management. Developed by the American Pain Society, the questionnaire aims to assess patient-centered outcomes in acute pain management.
The scoring system of the APS-POQ varies depending on the version used and the study's objectives. However, in general, the items in the questionnaire assess various aspects of pain's impact, and lower scores typically indicate better outcomes.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Jun 2023
- Primary completion15 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis; GallstoneStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Application of the experimental group: 2 hours after the surgery, TENS will be applied for 30 minutes and then TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). In order to protect sleep integrity, TENS application hours will be arranged according to the patient. Application of the control group: TENS will not be applied to this group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansel Bozer, Cukurova University
- Investigators
- Cansel Bozer, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962853
- Sponsor's protocol ID
- CU-SBF-CB-02
- Acronym
- TENS
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trans Electrical Nerve Stimulation on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05962853
- Acronym / sponsor ID
- TENS / CU-SBF-CB-02
- Conditions
- Cholecystitis; Gallstone, Cholecystolithiasis
- Keywords
- Pain, Cholecystectomy, Nurse, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 27 Jul 2023 (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.
The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve Stimulation) on patient outcomes after laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute cholecystitis and gallstone pancreatitis.Many complications can be seen after laparoscopic cholecystectomy.
The most common complication after laparoscopic cholecystectomy is pain. Pain appears as incisional, visceral and shoulder pain after laparoscopic cholecystectomy.After laparoscopic surgery, increased intra-abdominal pressure, stretching of the peritoneum, inability to take air given carbon dioxide (CO2), shoulder pain due to tension of muscle fibers due to diaphragm irritation, and visceral pain due to the interference of trocars on the abdominal wall as a result of intra-abdominal intervention are seen. After laparoscopic cholecystectomy, the effect of general anesthesia and the proximity of the incision area to the diaphragm may also cause pulmonary complications. Pneumoperiteneum developed by the administration of CO2 gas after laparoscopic cholecystectomy; Diaphragmatic irritation, increased intra-abdominal pressure, stretching of the peritoneum, and consequently the tension in the muscle fibers in the diaphragm can cause pain.
Inability to control pain can lead to many undesirable conditions in the patient, such as reluctance to mobilize, increased oxygen consumption, and delayed wound healing. This situation is also associated with increased hospital stay and financial burdens.In order to provide effective pain control, the combined use of pharmacological and non-pharmacological methods is important.Non-pharmacological methods are easy to learn, safe, have no definite contraindications, and provide pain management with non-drug applications. In a meta-analysis, it was determined that Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, safe non-pharmacological method for symptomatic relief of pain and discomfort and no serious side effects were observed.
Studies have shown that TENS application reduces postoperative pain level and analgesia consumption. In addition, TENS application after laparoscopic cholecystectomy was found to be associated with a decrease in postoperative pain severity and complaints of nausea and vomiting. It is seen that there are not enough resources in the literature regarding the application of TENS after laparoscopic cholecystectomy.
The aim of this study is to evaluate the effect of TENS on patient outcomes after laparoscopic cholecystectomy.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Application of the experimental group: 2 hours after the surgery, TENS will be applied for 30 minutes and then TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). In order to protect sleep integrity, TENS application hours will be arranged according to the patient. Application of the control group: TENS will not be applied to this group
| Arm | Type | Receives |
|---|---|---|
| Experimental group ( TENS will be applied ) | Experimental | Other: Experimental group (Transcutaneous Electrical Nerve Stimulation)After 30 minutes of TENS application 2 hours after the surgery, TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). TENS application hours will be arranged according to the patient in order to protect sleep integrity. |
| Control Group ( TENS will not be applied ) | No intervention | –Application of the control group: TENS will not be applied to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Over 18 years old,
- Without pacemaker and arrhythmia,
- No previous history of chronic pain, alcohol or drug addiction,
- Not using TENS/opioids before surgery,
- Epidural analgesia is not applied in the postoperative period, without cognitive impairment,
Key exclusion criteria (1 listed)
- refuse to participate in the study
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 |
|---|---|---|
| Experimental group (Transcutaneous Electrical Nerve Stimulation)The application will be applied at 8 hour intervals in the first 24 hours after the surgery. | Other | Experimental group ( TENS will be applied ) |
Primary outcome
The Numerical Rating Scale (NRS)
Time frame: 24 hours
The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.
1 secondary outcome
American Pain Society Patient Outcome
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cansel Bozer principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group (Transcutaneous Electrical Nerve Stimulation) in people with Cholecystitis; Gallstone and Cholecystolithiasis, run by Cukurova 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 13 inclusion and 1 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: finished, as of the sponsor's last update on 12 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numerical Rating Scale (NRS) (time frame: 24 hours). 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 12 Sep 2025.