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

Primary Purpose

Critical Illness, Mechanical Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Personalized music
Personalized music plus earplug
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring music therapy, intensive care unit, delirium

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Personalized music intervention group

Personalized music plus earplug group

Control group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Pain score
Pain score is assessed by Critical-Care Pain Observation Tool (CPOT). CPOT score will be reported.
Sleep quality
Sleep parameters are measured by mini motionlogger actigraph. Sleep parameters will be reported.
Change from baseline on heart rate variability (HRV)
Heart rate variability is measured by portable ECG recorder and analyzer.
Duration of mechanical ventilation
The total days of mechanical ventilation.
Length of ICU stay
The total days of ICU stay.
Sedation time
The total time of sedation drug used.
Mortality
The number of death in a period of time.

Full Information

First Posted
August 16, 2019
Last Updated
September 12, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04065256
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation
Keywords
music therapy, intensive care unit, delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized music intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Personalized music plus earplug group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group involves neither music intervention nor using earplug at night.
Intervention Type
Other
Intervention Name(s)
Personalized music
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Personalized music plus earplug
Intervention Description
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.
Primary Outcome Measure Information:
Title
Delirium incidence
Description
The number of patients who with delirium. The delirium event is assessed by Intensive Care Delirium Screening Checklist (ICDSC).
Time Frame
Date of study enrollment through 7th day, or date of discharge from ICU.
Secondary Outcome Measure Information:
Title
Sedation level
Description
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.
Time Frame
Date of study enrollment through 7th day, or date of discharge from ICU.
Title
Pain score
Description
Pain score is assessed by Critical-Care Pain Observation Tool (CPOT). CPOT score will be reported.
Time Frame
Date of study enrollment through 7th day, or date of discharge from ICU.
Title
Sleep quality
Description
Sleep parameters are measured by mini motionlogger actigraph. Sleep parameters will be reported.
Time Frame
Date of study enrollment through 7th day, or date of discharge from ICU.
Title
Change from baseline on heart rate variability (HRV)
Description
Heart rate variability is measured by portable ECG recorder and analyzer.
Time Frame
The date of enrollment, the 4th day, and the 7th day.
Title
Duration of mechanical ventilation
Description
The total days of mechanical ventilation.
Time Frame
Date of study enrollment through weaning from mechanical ventilation, or date of study enrollment up to 90 days.
Title
Length of ICU stay
Description
The total days of ICU stay.
Time Frame
Date of study enrollment through discharge from ICU, or date of study enrollment up to 90 days.
Title
Sedation time
Description
The total time of sedation drug used.
Time Frame
Date of study enrollment through 7th day or discharge from ICU
Title
Mortality
Description
The number of death in a period of time.
Time Frame
The time points of measurement are 30th and 90th days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Yean Chiu, PhD
Phone
+886-2-27361661
Ext
6329
Email
hychiu0315@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisao Yean Chiu, PhD
Phone
886227361661
Ext
6329
Email
hychiu0315@tmu.edu.tw

12. IPD Sharing Statement

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

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