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The Effect of Tomatis Auditory Rehabilitation Training on Delirium: A Prospective, Two-center, Double-blind, Randomized Controlled Clinical Trial

The Effect of Tomatis Auditory Rehabilitation Training on Delirium: A Prospective, Two-center, Double-blind, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107056
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Delirium

Interventions

Experimental group:Trained in TAR Routine care: Core program input volume is 65dB. The treatment consists of 20 subsections, each subsection is 30 minutes
Treatment for 3 consecutive days
Avoid eating times.
Control group:Sham stimulation Routine diagnosis and treatment: The input volume of the core program is 0dB, and the rest is the same as that of the experimental group.

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-85 years old; 2. Patients who underwent cardiac surgery under general anesthesia and were admitted to the extracardiac ICU after surgery; 3. Meet DSM-V diagnostic delirium criteria; 4. Delirium occurs for the first time; 5. The legal guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Acute otitis media, total deafness in any ear; 2. History of dementia, schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery; 3. Severe liver and kidney insufficiency, cardiac insufficiency, head injury, severe lung infection and other clinical critical conditions; 4. The expected survival of more than 24 hours is low; 5. Any medical condition that prevents safe use of the headphones, such as skin breaks, burns, facial or skull fractures; 6. Participate in other clinical studies.

Design outcomes

Primary

MeasureTime frame
The delirium remission rate;

Secondary

MeasureTime frame
Anxiety Disorder Screening Scale and subscale scores;Geriatric Depression Scale and item scores;Pittsburgh Sleep Quality Index and individual item scores;Brief Mental State Examination Scale Score;Chinese ICU Mobility Scale Score;Electrocardiogram parameters;Near-infrared spectroscopy Parameters;Clinical Parameters;Adverse events;

Countries

China

Contacts

Public ContactLu Xiao

The First Affiliated Hospital of Nanjing Medical University

luxiao1972@163.com+86 138 1395 8023

Outcome results

None listed

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