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Effects of ear muff or musical therapy on patients undergoing extracorporeal shock wave lithotripsis of the pancreas: a prospective randomized controlled study

Effects of ear muff or musical therapy on patients undergoing extracorporeal shock wave lithotripsis of the pancreas: a prospective randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093715
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-10
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pancreatitis with pancreatic duct stones

Interventions

Group C:No special intervention for patients
Group M:Wearing soundproof headphones to listen to music
Group E:Wearing soundproof earmuff

Sponsors

ShangHai ChangHai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age>18 years old and<=70 years old; BMI 18-30 kg/m^2; ASA levels I-III; The planned anesthesia method is PSA; The patient agrees and signs an informed consent form.

Exclusion criteria

Exclusion criteria: Moderate or above hearing loss, as well as ear diseases or discomfort such as tinnitus, otitis media, and ear pain; Individuals with ulcers, damages, infections, etc. on their head and facial skin who are not suitable for wearing earmuffs or headphones; Individuals with moderate or above abnormal heart and lung function (such as severe arrhythmia, conduction block, heart failure, hypertrophic cardiomyopathy, dilated cardiomyopathy, pulmonary heart disease, severe valve disease, and respiratory failure); Patients with severe liver and kidney dysfunction (liver enzymes>2 times normal, urea nitrogen>8.2 µ mol/L, creatinine>133 µ mol/L); Individuals who use anticoagulants or have coagulation dysfunction (PT>17 s or APTT>47 s); Individuals who are allergic to the anesthetics used.

Design outcomes

Primary

MeasureTime frame
Intraoperative effector chamber concentration of remifentanil pumped by TCI;

Secondary

MeasureTime frame
Incidence of intraoperative hypoxemia;Anxiety score and pain score 30 min after operation;Ear discomfort such as tinnitus, earache, auditory hallucination;High energy crushing times;Patient, anesthesiologist and operating physician satisfaction scores;Total consumption of remifentanil;Effect chamber concentration and total consumption of propofol;Times of intraoperative body movements;Incidence of intraoperative and postoperative nausea, vomiting and pruritus;Induction and recovery time of anesthesia;

Countries

China

Contacts

Public ContactBo Li

ShangHai ChangHai Hospital

ishilibo@163.com+86 21 31161853

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026