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 applicable, Not yet recruiting, 60 participants, Li Fang

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Registry	NCT07607626
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	Li Fang (Other)
Conditions	Stone;Renal, Stone Ureter
Interventions	Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy, Standard Local Anesthesia (Behavioral, other)
Dates	start 2026-06-01 (estimated), primary completion 2027-07-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-05-26, last updated 2026-05-26

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy	Experimental	Behavioral: 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.
Standard Local Anesthesia	Active comparator	Other: 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.

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

+Outcome measures

Primary outcomes

Pain Score During Ureteral Access Sheath Placement [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 [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.

+Eligibility

Sex: All, ages: 18 Years to any

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 -

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