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

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    63
  • sponsor
    Taipei Medical University
Updated on 7 October 2022

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.

Details
Condition Critical Illness, Mechanical Ventilation
Treatment Personalized music, Personalized music plus earplug
Clinical Study IdentifierNCT04065256
SponsorTaipei Medical University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note