Stone;Renal, Stone Ureter
Conditions
Brief 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.
Interventions
BEHAVIORALTraditional 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 to the treatment arm.
Standard Local Anesthesia
Sponsors
Li Fang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTli fang
Outcome results
None listed