Stone;RenalNCT07607626
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
A study testing Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy and Standard Local Anesthesia in people with Stone;Renal and Stone Ureter, run by Li Fang.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone;Renal, Stone Ureter
- What is being tested?
- Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy and Standard Local Anesthesia
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Stone;Renal, Stone Ureter
- Being tested
- Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy, Standard Local Anesthesia
- Medical subject headings
- Nephrolithiasis, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Acupoint Patch with Five-Element Music TherapyBehavioural
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 AnesthesiaOther
Standard Local Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy | Experimental | 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. Receives: Behavioral: Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy |
| Standard Local Anesthesia | Active comparator | 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. Receives: Other: Standard Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (at the time of ureteral access sheath placement)
Secondary outcomes (1)
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.
Measured: Preoperative (before entering the operating room) and postoperative (2 hours after surgery, after returning to the ward)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone;RenalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Fang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Fang, Ningbo No. 1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607626
- Sponsor's protocol ID
- MR-33-26-034106
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No