TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy (TENS-LC)

Nigde Omer Halisdemir University

Status: Enrolling

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

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07307703

22504254-050.04Cholecystectomy

Details and patient eligibility

About

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.

Full description

Gallstone disease is common in Western countries, and cholecystectomy is a routine abdominal surgical procedure. The laparoscopic approach is considered the gold standard. However, many patients experience acute postoperative pain, often reported as moderate to severe. Acute pain delays recovery and may lead to complications.

Opioids remain the cornerstone of postoperative pain management, but they are associated with adverse effects such as sedation, nausea, respiratory depression, and opioid-induced hyperalgesia. In addition, long-term problematic opioid use has been reported in 6-8% of patients after surgery. Therefore, non-pharmacological alternatives for postoperative pain relief are urgently needed.

Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive intervention that delivers electrical currents through electrodes placed on intact skin. Evidence from systematic reviews and meta-analyses suggests that TENS is effective and safe for managing both acute and chronic pain, with minimal side effects and low cost. Patients may experience mild tingling or discomfort, and rarely skin irritation.

Despite promising data, few studies have evaluated the combined effects of TENS on surgical anxiety, postoperative pain, and patient satisfaction in laparoscopic cholecystectomy. Most prior research has focused only on pain outcomes, neglecting psychological dimensions and patient-centered measures. This study aims to fill that gap by assessing whether TENS can reduce perioperative anxiety, improve pain control, and enhance satisfaction with surgical care.

This randomized controlled trial will be conducted at Adana City Training and Research Hospital between October 2025 and October 2026. Eligible patients undergoing elective laparoscopic cholecystectomy will be randomized into two groups: a TENS intervention group and a control group receiving standard care. The sample size was determined by power analysis, requiring 40 participants per group (total n=80).

Data collection will include:

Personal Information Form (demographics and baseline characteristics)

Visual Analog Scale (VAS) for pain intensity

Surgery-Specific Anxiety Scale (validated Turkish instrument)

Newcastle Satisfaction with Nursing Care Scale (validated Turkish version)

Exclusion criteria include emergency cholecystectomy, conversion to open surgery, presence of pacemakers or implanted devices, uncontrolled epilepsy, chronic opioid use, severe psychiatric or cognitive disorders, dermatological contraindications, or concurrent participation in another clinical trial.

The primary outcomes are surgical anxiety, postoperative pain, and patient satisfaction. Secondary outcomes include recovery parameters and adverse events.

Hypotheses:

Null hypothesis (H0): TENS has no effect on surgical anxiety, postoperative pain, or patient satisfaction in laparoscopic cholecystectomy.

Alternative hypothesis (H1): TENS reduces surgical anxiety and postoperative pain while increasing patient satisfaction.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Arm 1 TENS Group

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Control Group

No Intervention group

Description:

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.