Urinary Calculus
Conditions
Keywords
Transcutaneous Electrical Nerve Stimulation, Retrograde Intrarenal Surgery, Quality of Recovery
Brief summary
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.
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation
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.
Sponsors
Bozok University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study employs a prospective, randomized, controlled, two-arm intervention model. Eligible participants will be randomly assigned to either the TENS intervention group or the control group using a simple randomization method. The intervention group will receive standardized TENS applications during the first 24 hours postoperatively in addition to routine postoperative care, while the control group will receive routine care only. Outcome measures, including pain intensity, frequency of nausea and vomiting, and quality of recovery, will be assessed at predefined time points using validated measurement scales by blinded assessors to minimize bias. Data will be analyzed comparatively between groups to determine the effectiveness of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure (postoperative pain intensity) | 0-24 hours postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea and Vomiting (PONV) Intensity Scale | 0-24 hours postoperatively | 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 |
| Quality of recovery | 24 hours postoperatively | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed