TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy

NCT07307703 | Recruiting

• 1 other identifier: 22504254-050.04Cholecystectomy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gallstone Disease; Postoperative Pain; Surgical Anxiety; Patient Satisfaction After Laparoscopic Cholecystectomy

Keywords

Laparoscopic Cholecystectomy; Gallstone Disease; Surgical Anxiety; Postoperative Pain; Transcutaneous Electrical Nerve Stimulation (TENS)

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity (VAS)

  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.

  Within the first 24 hours after surgery

• Postoperative Pain Intensity

  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.

  Within the first 24 hours after surgery

Study Arms (2)

Arm 1 TENS Group

EXPERIMENTAL

Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care for laparoscopic cholecystectomy. TENS will be applied using surface electrodes placed on intact skin before and after surgery. The stimulation parameters will follow established clinical guidelines to ensure safety and effectiveness. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Control Group

NO INTERVENTION

Participants in this arm will receive standard perioperative care for laparoscopic cholecystectomy without Transcutaneous Electrical Nerve Stimulation (TENS). Usual surgical and nursing protocols will be followed according to hospital standards. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction, which will be compared with the intervention group to evaluate the added effect of TENS.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Also known as: TENS Therapy, Electrical Nerve Stimulation

Arm 1 TENS Group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Adana City Hospital

Niğde, Adana, 51100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Kezban Koraş SÖZEN, Associate Professor

CONTACT

+90, 0543 805 62 09; kezbankoras@ohu.edu.tr

Abdurrahman ACAR, Research Assistant

CONTACT

+90, 0541 529 89 30; aacar@ohu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional parties are masked in this study. Due to the nature of the intervention (TENS), participants and care providers are aware of group allocation. The study is conducted as an open-label randomized controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Faculty of Health Sciences, Niğde Ömer Halisdemir University

Model Details: This study uses a parallel assignment model. Participants undergoing elective laparoscopic cholecystectomy will be randomly assigned to one of two groups: Intervention group: Patients will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care. Control group: Patients will receive standard perioperative care without TENS.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 29, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)