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Recruiting Not applicable

TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy

NCT07307703 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2025-12-29

Condition(s) studied

Gallstone DiseasePostoperative PainSurgical AnxietyPatient Satisfaction After Laparoscopic Cholecystectomy

Investigational drug(s) / intervention(s)

Transcutaneous Electrical Nerve Stimulation (TENS)

Transcutaneous Electrical Nerve Stimulation (TENS): Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive device-based intervention that delivers mild electrical currents through electrodes placed on intact skin. In this study, TENS will be applied perioperatively to patients undergoing laparoscopic cholecystectomy. The stimulation sessions will be conducted before and after surgery, following standardized clinical parameters to ensure safety and reproducibility. The intervention is designed to evaluate its effects on surgical anxiety, postoperative pain intensity, and patient satisfaction compared with standard care.

Study summary

This study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) can improve recovery for patients undergoing laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). TENS is a non-invasive method that uses mild electrical currents applied through the skin to stimulate nerves.

The main goals of the study are to determine if TENS can:

Reduce surgical anxiety before and during the procedure

Decrease postoperative pain after surgery

Improve overall patient satisfaction with their surgical experience

Patients who participate will receive standard surgical care, and some will also receive TENS therapy. Outcomes will be measured using patient questionnaires and clinical assessments during the hospital stay and follow-up period.

By comparing patients who receive TENS with those who do not, the study aims to provide evidence on whether this simple technique can enhance comfort and recovery after gallbladder surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postoperative Pain Intensity (VAS) — Within the first 24 hours after surgery
    Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.
  • Postoperative Pain Intensity — Within the first 24 hours after surgery
    Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.

Trial sites (1)

FacilityCityRegionStatus
Adana City Hospital Niğde Adana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07307703 on ClinicalTrials.gov ↗ ← All trials in Turkey