Clinical trial NCT04065256: Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit
Official title: Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Mechanical Ventilation
Keywords: music therapy
intensive care unit
delirium
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Delirium incidence
timeFrame: Date of study enrollment through 7th day, or date of discharge from ICU.
measure: Delirium/ coma free days
timeFrame: Date of study enrollment through 7th day, or date of discharge from ICU.
Secondary outcomes:
measure: Sedation level
timeFrame: Date of study enrollment through 7th day, or date of discharge from ICU.
measure: Pain score
timeFrame: Date of study enrollment through 7th day, or date of discharge from ICU.
measure: Sleep quality
timeFrame: Date of study enrollment through 7th day, or date of discharge from ICU.
measure: Change from baseline on heart rate variability (HRV)
timeFrame: The date of enrollment, the 4th day, and the 7th day.
measure: Duration of mechanical ventilation
timeFrame: Date of study enrollment through weaning from mechanical ventilation, or date of study enrollment up to 90 days.
measure: Length of ICU stay
timeFrame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 90 days.
measure: Sedation time
timeFrame: Date of study enrollment through 7th day or discharge from ICU
measure: Mortality
timeFrame: The time points of measurement are 30th and 90th days.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Study officials:
References: