Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy

NCT05962853 | Completed

• 1 other identifier: CU-SBF-CB-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve Stimulation) on patient outcomes after laparoscopic cholecystectomy.

Conditions

Cholecystitis; Gallstone; Cholecystolithiasis

Keywords

Pain; Cholecystectomy; Nurse; TENS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• American Pain Society Patient Outcome

  24 hours

Study Arms (2)

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.

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.

Interventions

Experimental group (Transcutaneous Electrical Nerve Stimulation) OTHER

The application will be applied at 8 hour intervals in the first 24 hours after the surgery.

Experimental group ( TENS will be applied )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• refuse to participate in the study

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yüreğir / Adana, 01220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholecystitis; Gallstones; Cholecystolithiasis; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Cansel Bozer

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Application will be made by the researcher and the outcome will be assessements will be performed by a investigator who is blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist nurse

Model Details: 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

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: June 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: June 15, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)