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
19. maj 2026 opdateret af: Li Fang
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: li fang
- Telefonnummer: 8613586681743
- E-mail: fyyfangli@nbu.edu.cn
Deltagelseskriterier
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Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 -
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Traditional Chinese Medicine Acupoint Patch with Five-Element Music Therapy
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.
|
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.
|
|
Aktiv komparator: Standard Local Anesthesia
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.
|
Standard Local Anesthesia
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Score During Ureteral Access Sheath Placement
Tidsramme: 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.
|
Intraoperative (at the time of ureteral access sheath placement)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety Score Before and After Surgery
Tidsramme: 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.
|
Preoperative (before entering the operating room) and postoperative (2 hours after surgery, after returning to the ward)
|
Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. juli 2027
Datoer for studieregistrering
Først indsendt
19. maj 2026
Først indsendt, der opfyldte QC-kriterier
19. maj 2026
Først opslået (Faktiske)
26. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MR-33-26-034106
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