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.

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Key information

Conditions

Stone;Renal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Stone Ureter Ureteral Diseases Ureterolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

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.

Standard Local Anesthesia

Other

Standard Local Anesthesia

Primary outcomes

Pain Score During Ureteral Access Sheath Placement

Time frame: Intraoperative (at the time of 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.

Secondary outcomes

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)

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.

Study contacts

Contact information is provided by the study sponsor or research team.

li fang

CONTACT

[email protected]

8613586681743

Sponsors and collaborators

Lead sponsor

Li Fang

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 26, 2026
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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