TENS to reduce anxiety, pain, and improve satisfaction after laparoscopic gallbladder removal
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Surgical Anxiety, Postoperative Pain, and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy
This trial will try TENS (mild electrical stimulation through the skin) in adults having elective laparoscopic gallbladder removal to see if it lowers anxiety, reduces postoperative pain, and improves satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 1 site (Niğde, Adana) |
| Trial ID | NCT07307703 on ClinicalTrials.gov |
What this trial studies
This interventional study compares standard perioperative care with and without transcutaneous electrical nerve stimulation (TENS) in adults undergoing elective laparoscopic cholecystectomy. Participants who meet eligibility criteria will receive routine surgical care, and some will also receive TENS applied through skin electrodes before, during, or after the operation according to the protocol. Outcomes include validated measures of surgical anxiety, postoperative pain scores, opioid use, and patient satisfaction collected during the hospital stay and at follow-up visits. The intervention is non-invasive, generally well tolerated, and safety will be monitored by clinical assessments and patient-reported side effects such as skin irritation or tingling.
Who should consider this trial
Good fit: Adults aged 18–65 scheduled for elective laparoscopic cholecystectomy with ASA physical status I–II who can consent and have no contraindications to TENS are ideal candidates.
Not a fit: Patients with implanted electrical devices (like pacemakers), epilepsy, severe neuropathy, active skin lesions at electrode sites, ASA III or higher, emergency surgery or conversion to open surgery, pregnancy, or those unable/unwilling to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, TENS could lower perioperative anxiety and postoperative pain, reduce opioid requirements, and improve patients' overall satisfaction with their gallbladder surgery experience.
How similar studies have performed: Systematic reviews and meta-analyses have shown TENS can reduce acute and chronic pain with few side effects, but few prior studies have simultaneously measured surgical anxiety and patient satisfaction specifically after laparoscopic cholecystectomy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Niğde, Adana
- Adana City Hospital — Niğde, Adana, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Kezban Koraş SÖZEN, Associate Professor
- Email: kezbankoras@ohu.edu.tr
- Phone: +90, 0543 805 62 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.