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Not yet recruiting NCT07607626

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

No phase Interventional Stone;Renal Stone Ureter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy, Standard Local Anesthesia.
Who it may be relevant to
Registry conditions: Stone;Renal, Stone Ureter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

  • 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 t
  • Other Standard Local Anesthesia
    Standard Local Anesthesia

Primary outcome measures

  • Pain Score During Ureteral Access Sheath Placement [Time frame: Intraoperative (at the time of ureteral access sheath placement)]
Secondary outcome measures (1)
  • Anxiety Score Before and After Surgery [Time frame: Preoperative (before entering the operating room) and postoperative (2 hours after surgery, after returning to the ward)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07607626 · MR-33-26-034106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗