The Effect of Transcutaneous Electrical Nerve Stimulation in Patients After Retrograde Intrarenal Surgery

N/AActive Not RecruitingNCT07405502

Bozok University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Calculus

Interventions

This intervention is distinguished by the early, standardized, and nonpharmacological application of Transcutaneous Electrical Nerve Stimulation (TENS) within the first 24 hours following Retrograde Intrarenal Surgery (RIRS). Unlike conventional postoperative management that primarily relies on pharmacological analgesics and antiemetics, this approach emphasizes a nurse-administered, bedside, and patient-centered neuromodulation technique that is integrated into routine care without adding invasive procedures. The use of uniform stimulation parameters, predefined electrode placement protocols, and blinded outcome assessment ensures consistency and methodological rigor, allowing the specific effects of TENS on postoperative pain, nausea, vomiting, and quality of recovery to be isolated and compared reliably against standard care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Primary Outcome Measure (postoperative pain intensity)

The primary outcome of this study is the intensity of postoperative pain within the first 24 hours following retrograde intrarenal surgery (RIRS). Pain level will be assessed using the validated and reliable Numerical Rating Scale (NRS). Scale Description: Scale name: Numerical Rating Scale (NRS) Minimum value: 0 (no pain) Maximum value: 10 (unbearable pain) Higher score: Indicates a worse clinical outcome Unit of Measure: Scale total score

Time frame: 0-24 hours postoperatively

Secondary Outcomes

Postoperative Nausea and Vomiting (PONV) Intensity Scale

The frequency and severity of nausea and vomiting occurring within the first 24 hours after surgery will be assessed and recorded using the Postoperative Nausea and Vomiting (PONV) Intensity Scale. Scale Description: Scale name: Postoperative Nausea and Vomiting (PONV) Intensity Scale Minimum value: 0 (no nausea/vomiting) Maximum value: 4 (severe and persistent nausea/vomiting) Higher score: Indicates a worse clinical outcome Unit of Measure: Scale total score

Time frame: 0-24 hours postoperatively

Quality of recovery

The quality of postoperative recovery will be assessed using the Quality of Recovery-15 Questionnaire (QoR-15), which has proven validity and reliability. Scale Description: Scale name: Quality of Recovery-15 (QoR-15) Minimum value: 0 Maximum value: 150 Higher score: Indicates better recovery quality Unit of Measure: Scale total score

Time frame: 24 hours postoperatively