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

N/ANot Yet RecruitingNCT07607626

Li Fang60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stone;Renal Stone Ureter

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 -

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative (at the time of ureteral access sheath placement)

Secondary Outcomes

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.

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