Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit

NCT04065256 | Completed

• 1 other identifier: N201905008
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Delirium is a common acute confusion state in patients in intensive care units (ICUs). It has been linked to poor clinical prognoses (e.g., prolonged ICU stay) in critical patients. Furthermore, it might connect with long-term cognitive dysfunction. Mostly, pharmacological treatments have been frequently prescribed for preventing ICU delirium; however, their side effects might subsequently increase the risks of ICU delirium. Therefore, developing an effective non-pharmacological intervention of preventing delirium among critically mechanical ventilated patients is of clinical relevance. Purposes: To examine the effects of music intervention on reducing delirium in mechanically ventilated critical patients, to determine its beneficial effects on delirium-related outcomes, including sedation time, the duration of mechanical ventilation, and the length of ICU stay, and to compare the change of heart rate variability between groups.

Conditions

Critical Illness; Mechanical Ventilation

Keywords

music therapy; intensive care unit; delirium

Outcome Measures

Primary Outcomes (2)

• Delirium incidence

  The number of patients who with delirium. The delirium event is assessed by Intensive Care Delirium Screening Checklist (ICDSC).

  Date of study enrollment through 7th day, or date of discharge from ICU.

• Delirium/ coma free days

  The number of days that free from delirium or coma status

  Date of study enrollment through 7th day, or date of discharge from ICU.

Secondary Outcomes (8)

• Sedation level

  Date of study enrollment through 7th day, or date of discharge from ICU.

• Pain score

  Date of study enrollment through 7th day, or date of discharge from ICU.

• Sleep quality

  Date of study enrollment through 7th day, or date of discharge from ICU.

• Change from baseline on heart rate variability (HRV)

  The date of enrollment, the 4th day, and the 7th day.

• Duration of mechanical ventilation

  Date of study enrollment through weaning from mechanical ventilation, or date of study enrollment up to 90 days.

Study Arms (3)

Personalized music intervention group

EXPERIMENTAL

Participants will receive a personalized music session for forty minutes twice a day for consecutive seven days or until discharge from ICU. A total treatment dosage of 560 minutes is required.

Other: Personalized music

Personalized music plus earplug group

EXPERIMENTAL

Participants will receive a personalized music session for forty minutes twice a day for consecutive seven days or until discharge from ICU. In addition, using earplug during night time sleep. The music intervention total treatment dosage of 560 minutes is required.

Other: Personalized music plus earplug

Control group

NO INTERVENTION

The control group involves neither music intervention nor using earplug at night.

Interventions

Personalized music OTHER

Personalized music intervention will be conducted by research nurse independently. Firstly, the music preference will be confirmed by using predesigned music list. After confirming the music preference, participants will receive a music session for forty minutes through headphone and MP3 player.

Personalized music intervention group

Personalized music plus earplug OTHER

Personalized music intervention will be conducted by research nurse independently. Firstly, the music preference will be confirmed by using predesigned music list. After confirming the music preference, participants will receive a music session for forty minutes through headphone and MP3 player. In addition, participants will be worn earplug during night time sleep for decreasing the noise until next morning.

Personalized music plus earplug group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 20 to 85 years
• Expected to receive mechanical ventilation more than 24 hours
• Be able to communicate with others using verbal or non-verbal (such as paper and pencil) approaches when enrollment.

You may not qualify if:

• Dementia
• Psychiatric illness
• Suspected or confirmed drug or alcohol intoxication/overdose or withdrawal
• Severe or uncorrected hearing impairment
• Coma status after cardiac arrest or/and hypothermia treatment
• Deep sedation needed (RASS=-4\~-5 or SAS=1\~2)
• Expected death within 24h
• Delirium history during this admission
• Attending physician or healthcare team refusal

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Critical Illness; Delirium

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 22, 2019
• Study Start: June 5, 2020
• Primary Completion: November 3, 2023
• Study Completion: February 29, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

TW (1)