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

NCT07607626 | Not Yet Recruiting

• 1 other identifier: MR-33-26-034106
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stone;Renal; Stone Ureter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety Score Before and After Surgery

  Preoperative (before entering the operating room) and postoperative (2 hours after surgery, after returning to the ward)

Study Arms (2)

Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy

EXPERIMENTAL

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

Standard Local Anesthesia

ACTIVE COMPARATOR

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

Interventions

Standard Local Anesthesia OTHER

Standard Local Anesthesia

Standard Local Anesthesia

Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy BEHAVIORAL

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.

Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Li Fang: lead

MeSH Terms

Conditions

Nephrolithiasis; Ureterolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Ureteral Diseases

Central Study Contacts

li fang

CONTACT

8613586681743; fyyfangli@nbu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share