NCT07307703

TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nigde Omer Halisdemir University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Turkey (Türkiye)