Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07307703

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Surgical Anxiety, Postoperative Pain, and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy

Led by Nigde Omer Halisdemir University · Updated on 2025-12-29

80

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive method using mild electrical currents applied through the skin, can improve recovery after laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). This study aims to see if TENS can reduce surgical anxiety, decrease postoperative pain, and improve overall patient satisfaction compared with standard surgical care. The trial addresses the need for alternatives to opioid pain management due to their side effects and risks. Participants will be randomly assigned to either receive TENS therapy alongside standard care or standard care alone. TENS will be applied using surface electrodes before and after surgery following clinical guidelines. The study will compare outcomes such as surgical anxiety, pain intensity, and patient satisfaction between the two groups. Data collection includes patient questionnaires and clinical assessments during the hospital stay and follow-up. During the study, participants will complete assessments including a visual analog scale for pain, a surgery-specific anxiety scale, and a satisfaction questionnaire. Researchers will monitor these outcomes within the first 24 hours after surgery. The study is conducted over a period from December 2025 to September 2026, involving 80 patients aged 18 to 65 scheduled for elective laparoscopic cholecystectomy. Safety monitoring will exclude patients with certain conditions like implanted devices or skin issues at electrode sites.

CONDITIONS

Brief Title

TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-65 years scheduled for elective laparoscopic cholecystectomy
  • ASA physical status classification I-II
  • Ability to understand study procedures and provide written informed consent
  • No contraindications to TENS application (intact skin at electrode sites)
  • Willingness to comply with perioperative assessments (pain, anxiety, satisfaction scales)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo laparoscopic cholecystectomy surgery. Those in the TENS group receive Transcutaneous Electrical Nerve Stimulation before and after surgery to help reduce surgical anxiety and postoperative pain.

1 surgery day visit with TENS sessions before and after surgery

Post-operative Follow-up

Duration - Within the first 24 hours after surgery

Participants are monitored for postoperative pain intensity, surgical anxiety, and patient satisfaction within the first 24 hours after surgery.

1 post-operative visit within 24 hours

Trial Site Locations

Total: 1 location

1

Adana City Hospital

Niğde, Adana, Turkey (Türkiye), 51100

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Research Team

K

Kezban Koraş SÖZEN, Associate Professor

A

Abdurrahman ACAR, Research Assistant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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