About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy
BehavioralA 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 interventionStandard Local Anesthesia
Treatment groups
Trial 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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Li Fang
Lead sponsor
Ningbo No. 1 Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: