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

Critical Illness Clinical Trial

Official title:

Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065256
• Other study ID #: N201905008
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Delirium is a common acute confusion state among critical patients in intensive care units (ICUs). The symptoms are serious disturbance in mental abilities which may cause inattention, confused thinking, agitated mood, and fluctuated consciousness. Delirium also lead to higher mortality, longer hospital stay, higher cost of healthcare and poor recovery. However, the mechanism of delirium still not fully understand. Imbalanced neurotransmitters may be one of the possible explain for such situation. It is related to increased level of dopamine and acetylcholine deficiency. In addition, the relation between low level of melatonin and postoperative delirium was also reported. Glucocorticoid which represent the stress response is also related to postoperative delirium. Both changes of neurotransmitters and hormone levels would affect sleep-awake cycle. It is observed that patients who is delirium show a relative higher EEG theta power and a reduced alpha power than non-delirious patients. Several modifiable risk factors, such as noise, light, physical restrain, pain, anxiety, and sedatives, may contribute to poor sleep quality or sleep disruption and further delirium occurrence. Effectiveness interventions are extremely important when patients are inevitably exposed to such risk factors.

Pharmacological interventions are rapid and effective way for delirium management. However, the concern about side effect and increased mortality among high risk patients are needed. According to 2018 Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU, non-pharmacological intervention was suggested for delirium management firstly. Non-pharmacological interventions, such as using earplug or eye mask at night, music therapy or early mobilization, should be safe, less side effect and widely applicable for first-line healthcare providers. In addition, multicomponent interventions should be more effective than single component intervention. However, the evidence of direct comparison is limited.

Music intervention is a non-invasive, low-cost and non-pharmacological intervention. Several clinical trials were proved that music therapy could reduce the pain and anxiety among postoperative and old age population for better clinical progress. Listening to soft music can enhance brain alpha wave, and there is a negative correlation between alpha wave of EEG and sympathetic excitation. The preference of music also influences power of alpha wave. Recent studies report that implying music intervention on postoperative patients could lead to fewer acute confusion status, however, the incidence and potential exposed risk factors of delirium between medical and surgical populations were different. The effect of music intervention on medical critical patients and the related mechanism still need further investigation. In addition, whether the multicomponent intervention could obtain greater effect than single component intervention still not ascertained. Furthermore, the evidences of music intervention in decreasing the duration of mechanical ventilation, length of ICU stay, sedation time and mortality were still lacking. The mechanism between music intervention and delirium occurrence also need to further investigate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 29, 2024
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age from 20 to 85 years

2. Expected to receive mechanical ventilation more than 24 hours

3. Be able to communicate with others using verbal or non-verbal (such as paper and pencil) approaches when enrollment.

Exclusion Criteria:

1. Dementia

2. Psychiatric illness

3. Suspected or confirmed drug or alcohol intoxication/overdose or withdrawal

4. Severe or uncorrected hearing impairment

5. Coma status after cardiac arrest or/and hypothermia treatment

6. Deep sedation needed (RASS=-4~-5 or SAS=1~2)

7. Expected death within 24h

8. Delirium history during this admission

9. Attending physician or healthcare team refusal

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Mechanical Ventilation

Intervention

Other:
• Personalized music
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 plus earplug
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Sedation level	Sedation level is assessed by Richmond Agitation-Sedation Scale (RASS). It is a ranking scale with 10-level (+4 "combative" to -5 "unarousable") used to measure the agitation or sedation level of a person. RASS score will be reported.	Date of study enrollment through 7th day, or date of discharge from ICU.
Secondary	Pain score	Pain score is assessed by Critical-Care Pain Observation Tool (CPOT). CPOT score will be reported.	Date of study enrollment through 7th day, or date of discharge from ICU.
Secondary	Sleep quality	Sleep parameters are measured by mini motionlogger actigraph. Sleep parameters will be reported.	Date of study enrollment through 7th day, or date of discharge from ICU.
Secondary	Change from baseline on heart rate variability (HRV)	Heart rate variability is measured by portable ECG recorder and analyzer.	The date of enrollment, the 4th day, and the 7th day.
Secondary	Duration of mechanical ventilation	The total days of mechanical ventilation.	Date of study enrollment through weaning from mechanical ventilation, or date of study enrollment up to 90 days.
Secondary	Length of ICU stay	The total days of ICU stay.	Date of study enrollment through discharge from ICU, or date of study enrollment up to 90 days.
Secondary	Sedation time	The total time of sedation drug used.	Date of study enrollment through 7th day or discharge from ICU
Secondary	Mortality	The number of death in a period of time.	The time points of measurement are 30th and 90th days.