Vibroacoustic music therapy for postoperative delirium in the intensive care unit: A randomized controlled trial

Not Applicable

Recruiting

• Conditions: F05; Delirium, not induced by alcohol and other psychoactive substances

• Registration Number: DRKS00031985
• Lead Sponsor: niversität Augsburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Inclusion criteria are met if participants:a) are at least 18 years old, b) meet the criteria for postoperative delirium according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) or the International Classification of Diseases (ICD) 10 (codes: F05), c) score at least 4 on the Intensive Care Delirium Screening Checklist (IDCS), d) have legal guardianship/power of attorney, and e) are expected to be in intensive care for longer than 2 days.

Exclusion Criteria

Participation in the study is not possible, a) the presence of acute or chronic neurological or neurosurgical cerebral disease with cognitive impairment, b) the presence of acute or chronic psychiatric illness, c) the presence of current alcohol and/ or substance intoxication/overdose or withdrawal, d) death is expected within the next 72h after enrollment, e) recording of delirium is not possible (e.g., due to language barrier, aphasia, etc.), f) the patient is ventilated, g) the patient is pregnant or breastfeeding, g) there is a severe uncorrected hearing impairment, h) the patient is placed in an institution by court or official order, i) the patient has a personal relationship to the persons conducting the study (study management, study physicians, study therapists).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium duration, using the Intensive Care Delirium Screening Checklist (ICDSC).

Secondary Outcome Measures

Name	Time	Method
a) intensive care unit treatment duration since diagnosis of postoperative delirium, <br>b) level of agitation as measured by Richmond Agitation and Sedation Scale (RASS)*.<br>c) formal speech intelligibility, measured by audio recordings<br>d) duration and dose of drug therapy for delirium<br>e) duration and type of restraint measures<br>f) subjective experience of patients, evaluation interview conducted two weeks after discharge from ICU <br><br>* Measurement during the process as routine measurement by nursing staff, as well as intra-individual pre-post measurement.