Application of Traditional Chinese Medicine Five-Element Music Therapy Combined With Acupoint Patch Therapy Based on the "Holistic Mind-Body Treatment" Theory in Upper Urinary Tract Calculi Treated With Ureteroscopic Lithotripsy Under Local Anesthesia

This study aims to evaluate whether the combination of Traditional Chinese Medicine Five-Element Music Therapy and acupoint patch therapy can effectively reduce intraoperative pain and anxiety in patients undergoing ureteroscopic lithotripsy for upper urinary tract calculi under local anesthesia, compared to conventional local anesthesia alone.

Study Overview

• Status: Not yet recruiting
• Conditions: Stone Ureter; Stone;Renal
• Intervention / Treatment: Behavioral: Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy; Other: Standard Local Anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: li fang; Phone Number: 8613586681743; Email: fyyfangli@nbu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older.
2. Computed tomography confirmed diagnosis of upper urinary tract calculi.
3. Stone size less than 2 cm in maximum diameter.
4. Scheduled to undergo primary ureteroscopic lithotripsy.
5. Normal hearing ability.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Congenital malformation of the urinary system
2. History of allergy to local anesthetics
3. Mental disorder that precludes cooperation with the surgical procedure
4. Uncontrolled urinary tract infection before surgery
5. Pregnancy
6. Pre-existing chronic pain syndrome or long-term use of analgesic medications
7. Long-term use of anti-anxiety medications -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy; Participants in this arm receive three interventions: (1) Traditional Chinese Medicine acupoint patch applied to bilateral Neiguan, Taichong, and Sanyinjiao four hours before surgery. The patch contains Angelica sinensis, Sinapis alba, Mosla chinensis, Cinnamomum cassia, and Corydalis yanhusuo. (2) Five-Element Music Therapy (predominantly Jiao mode) delivered via headphones from operating room entry until the end of surgery, with volume maintained at 40-60 decibels. (3) Standard local anesthesia protocol: intramuscular tramadol 100 mg half an hour before surgery plus intraurethral tetracaine perfusion for 10 minutes during surgery.	Behavioral: Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy; A topical herbal patch containing Angelica sinensis, Sinapis alba, Mosla chinensis, Cinnamomum cassia, and Corydalis yanhusuo. The patch is applied to bilateral Neiguan, Taichong, and Sanyinjiao acupoints four hours before surgery and removed two hours after surgery. The intervention aims to provide sustained analgesia, stabilize intraoperative vital signs, and reduce perioperative anxiety through transdermal absorption of active herbal components. This is an experimental intervention specific to the treatment arm.
Active Comparator: Standard Local Anesthesia; Participants in this arm receive standard local anesthesia only (intramuscular tramadol 100 mg half an hour before surgery plus intraurethral tetracaine perfusion for 10 minutes during surgery). A placebo acupoint patch (identical in appearance but containing no active ingredients) is applied to the same acupoints at the same time points. Participants wear headphones from operating room entry until the end of surgery but no music is played.	Other: Standard Local Anesthesia; Standard Local Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score During Ureteral Access Sheath Placement	Pain intensity measured by the Visual Analog Scale (VAS) at the time of ureteral access sheath placement (T2). The VAS is a 10-centimeter linear scale ranging from 0 (no pain) to 10 (worst possible pain). Participants mark their perceived pain level on the scale, and the score is recorded by a study nurse who is not involved in the surgical procedure. Higher scores indicate greater pain intensity.	Intraoperative (at the time of ureteral access sheath placement)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Score Before and After Surgery	Anxiety level assessed by the State Anxiety Inventory (S-AI) preoperatively (before entering the operating room) and postoperatively at 2 hours after surgery (T6, after returning to the ward). The S-AI consists of 20 items, each scored from 1 to 4, with total scores ranging from 20 to 80. Higher scores indicate greater anxiety. The scale is administered by a trained research assistant using standardized instructions.	Preoperative (before entering the operating room) and postoperative (2 hours after surgery, after returning to the ward)

Collaborators and Investigators

• Sponsor: Li Fang

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Ureteral Diseases; Nephrolithiasis; Ureterolithiasis
• Other Study ID Numbers: MR-33-26-034106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No