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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLi Fang

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Standard Local Anesthesia

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Traditional Chinese Medicine Acupoint Patch with Five-Element Music TherapyExperimental treatment 1 intervention
Group B: Standard Local AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

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.

Time frame
Preoperative (before entering the operating room) and postoperative (2 hours after surgery, after returning to the ward)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Li Fang

Lead sponsor

Ningbo No. 1 Hospital

Sponsor institution

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