An interventional study of Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy and Standard Local Anesthesia in Stone;Renal and Stone Ureter, sponsored by Li Fang. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Li Fang · Not applicable, Interventional, and Treatment
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.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's planned enrollment of 60 is below the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →This is the only study on the registry with Li Fang as lead sponsor.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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)
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jul 2027, 13 months later.
Of 134 non-industry interventional studies with no phase under Nephrolithiasis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 13 months is below that.
Counting every sponsor, half of 140 studies reached it within 24 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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