The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Nausea, Vomiting, and Quality of Recovery in Patients After Retrograde Intrarenal Surgery: A Randomized Controlled Trial
| Registry | NCT07405502, acronym RIRS TENS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 72 (Actual) |
| Sponsor | Bozok University (Other) |
| Conditions | Urinary Calculus |
| Interventions | Transcutaneous Electrical Nerve Stimulation (Device) |
| Dates | start 2025-08-01, primary completion 2025-12-01, completion 2026-05-01, first posted 2026-02-12, last updated 2026-07-07 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Urinary Calculus All trials of Transcutaneous Electrical Nerve Stimulation
This study is designed to evaluate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on pain, nausea, vomiting, and quality of recovery in patients undergoing Retrograde Intrarenal Surgery (RIRS). This prospective, randomized controlled trial, designed as a two-group study, will be conducted at the Department of Urology, Yozgat Bozok University Health Practice and Research Center between September 2025 and September 2026. A total of 72 patients who underwent RIRC and met the inclusion criteria will be included in the study. Participants will be randomly divided into two groups: an intervention group receiving TENS (n=36) and a control group without TENS (n=36). Pain levels, frequency of nausea and vomiting, and quality of recovery in both groups will be compared within the first 24 hours postoperatively. This study is expected to provide evidence-based data on the effectiveness of TENS, a non-pharmacological method, in symptom management after RIRS.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TENS group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation | Intervention Arm (TENS Group): Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard postoperative care following Retrograde Intrarenal Surgery (RIRS). TENS will be applied using surface electrodes placed on the appropriate dermatomal areas related to the surgical site. The stimulation parameters (frequency, intensity, and duration) will be standardized for all participants and administered within the first 24 hours postoperatively. The intervention aims to reduce postoperative pain, as well as the frequency of nausea and vomiting, and to improve overall quality of recovery. |
| Control Arm | No intervention | Control Arm (Standard Care Group): Participants in this arm will receive standard postoperative care only, without any TENS application. Standard care will include routine monitoring, prescribed analgesic and antiemetic medications as needed, mobilization, and nursing care according to institutional protocols. Outcomes related to pain, nausea, vomiting, and quality of recovery will be assessed at the same time points as in the intervention arm to allow for valid comparison between groups. |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: * Participants who have undergone RIRS will be included in our study. Eligibility criteria include being between 18 and 70 years of age, * Participants having an American Society of Anesthesiologists (ASA) physical status classification of I or II, * Participants must have sufficient cognitive function and language skills to proceed with the study. Exclusion Criteria: * Exclusion criteria include the presence of a painful condition (e.g., inflammatory rheumatic disease, lumbar muscle degeneration, lumbar disc protrusion with back pain, acute or chronic nephritis, and pyelonephritis), * Major organ system disease, * Participants with pacemakers, * Participants using analgesic medications or those with a history of significant drug abuse, * Those with uncontrolled hypertension, diabetes or malignancies, a history of epilepsy, pregnancy, and breastfeeding, * Participants in other clinical trials will also be excluded (Mora et al., 2007; Tu et al., 2019).
| Facility | City | Country | Status |
|---|---|---|---|
| Yozgat Bozok Univercity | Yozgat, Yozgat | Turkey (Türkiye) |