Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Surgical Anxiety, Postoperative Pain, and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity (VAS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Postoperative Pain Intensity (VAS)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Abdurrahman Acar
Research Assistant, Faculty of Health Sciences, Niğde Ömer Halisdemir University
Nigde Omer Halisdemir University