Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy (TENS)

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.

Study Overview

• Status: Completed
• Conditions: Cholecystolithiasis; Cholecystitis; Gallstone
• Intervention / Treatment: Other: Experimental group (Transcutaneous Electrical Nerve Stimulation)

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.

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• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yüreğir / Adana
    • Adana, Yüreğir / Adana, Turkey (Türkiye), 01220
      • Adana City Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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,
• 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.

Exclusion Criteria:

• refuse to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group ( TENS will be applied ); 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.	Other: Experimental group (Transcutaneous Electrical Nerve Stimulation); The application will be applied at 8 hour intervals in the first 24 hours after the surgery.
No Intervention: Control Group ( TENS will not be applied ); Application of the control group: TENS will not be applied to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Cansel Bozer, Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 7, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Nurse; TENS; Pain; Cholecystectomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Cholecystitis; Gallstones; Cholecystolithiasis; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: CU-SBF-CB-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No