TENS to reduce anxiety, pain, and improve satisfaction after laparoscopic gallbladder removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares standard perioperative care with and without transcutaneous electrical nerve stimulation (TENS) in adults undergoing elective laparoscopic cholecystectomy. Participants who meet eligibility criteria will receive routine surgical care, and some will also receive TENS applied through skin electrodes before, during, or after the operation according to the protocol. Outcomes include validated measures of surgical anxiety, postoperative pain scores, opioid use, and patient satisfaction collected during the hospital stay and at follow-up visits. The intervention is non-invasive, generally well tolerated, and safety will be monitored by clinical assessments and patient-reported side effects such as skin irritation or tingling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Where it's running

• Adana City Hospital
  Niğde, Adana, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Kezban Koraş SÖZEN, Associate Professor
• Email: kezbankoras@ohu.edu.tr
• Phone: +90, 0543 805 62 09

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.