Critical IllnessNCT04065256
Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit
A study testing Personalized music and Personalized music plus earplug in people with Critical Illness and Mechanical Ventilation, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Critical Illness, Mechanical Ventilation
- What is being tested?
- Personalized music and Personalized music plus earplug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2020to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Expected death within 24h
- Delirium history during this admission
- Attending physician or healthcare team refusal
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Taipei, 110
About this study
Official title: Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Critical Illness, Mechanical Ventilation
- Being tested
- Personalized music, Personalized music plus earplug
- Keywords
- music therapy, intensive care unit, delirium
- Medical subject headings
- Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized musicOther
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 earplugOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Personalized music plus earplug |
| Control group | No intervention | The control group involves neither music intervention nor using earplug at night. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium incidence
The number of patients who with delirium. The delirium event is assessed by Intensive Care Delirium Screening Checklist (ICDSC).
Measured: 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
Measured: Date of study enrollment through 7th day, or date of discharge from ICU.
Secondary outcomes (8)
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.
Measured: Date of study enrollment through 7th day, or date of discharge from ICU.
Pain score
Pain score is assessed by Critical-Care Pain Observation Tool (CPOT). CPOT score will be reported.
Measured: Date of study enrollment through 7th day, or date of discharge from ICU.
Sleep quality
Sleep parameters are measured by mini motionlogger actigraph. Sleep parameters will be reported.
Measured: Date of study enrollment through 7th day, or date of discharge from ICU.
Change from baseline on heart rate variability (HRV)
Heart rate variability is measured by portable ECG recorder and analyzer.
Measured: The date of enrollment, the 4th day, and the 7th day.
Duration of mechanical ventilation
The total days of mechanical ventilation.
Measured: Date of study enrollment through weaning from mechanical ventilation, or date of study enrollment up to 90 days.
Length of ICU stay
The total days of ICU stay.
Measured: Date of study enrollment through discharge from ICU, or date of study enrollment up to 90 days.
Sedation time
The total time of sedation drug used.
Measured: Date of study enrollment through 7th day or discharge from ICU
Mortality
The number of death in a period of time.
Measured: The time points of measurement are 30th and 90th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start5 Jun 2020
- Primary completion3 Nov 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065256
- Sponsor's protocol ID
- N201905008
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2019
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen TJ, Lin YY, Wang AY, Traynor V, Frost SA, Chung YW, Lin CJ, Wu CR, Tu MC, Lai KS, Chiu HY. Combined Use of Personalized Music Intervention and Earplugs (MUSE) to Prevent Delirium in Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial. Clin Nurs Res. 2026 Jul;35(6):300-311. doi: 10.1177/10547738261445264. Epub 2026 May 23.
PubMed 42175764
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04065256
- Acronym / sponsor ID
- N201905008
- Conditions
- Critical Illness, Mechanical Ventilation
- Keywords
- music therapy, intensive care unit, delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized music intervention group | Experimental | Other: Personalized musicParticipants 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. |
| Personalized music plus earplug group | Experimental | Other: Personalized music plus earplugParticipants 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. |
| Control group | No intervention | –The control group involves neither music intervention nor using earplug at night. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized musicPersonalized 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. | Other | Personalized music intervention group |
| Personalized music plus earplugPersonalized 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. | Other | Personalized music plus earplug group |
Primary outcome
Delirium incidence
Time frame: Date of study enrollment through 7th day, or date of discharge from ICU.
The number of patients who with delirium. The delirium event is assessed by Intensive Care Delirium Screening Checklist (ICDSC).
Delirium/ coma free days
Time frame: Date of study enrollment through 7th day, or date of discharge from ICU.
The number of days that free from delirium or coma status
8 secondary outcomes
Sedation level
Time frame: Date of study enrollment through 7th day, or date of discharge from ICU.
Pain score
Time frame: Date of study enrollment through 7th day, or date of discharge from ICU.
Sleep quality
Time frame: Date of study enrollment through 7th day, or date of discharge from ICU.
Change from baseline on heart rate variability (HRV)
Time frame: The date of enrollment, the 4th day, and the 7th day.
Duration of mechanical ventilation
Time frame: Date of study enrollment through weaning from mechanical ventilation, or date of study enrollment up to 90 days.
Length of ICU stay
Time frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 90 days.
Sedation time
Time frame: Date of study enrollment through 7th day or discharge from ICU
Mortality
Time frame: The time points of measurement are 30th and 90th days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 42175764Chen TJ, Lin YY, Wang AY, Traynor V, Frost SA, Chung YW, Lin CJ, Wu CR, Tu MC, Lai KS, Chiu HY. Combined Use of Personalized Music Intervention and Earplugs (MUSE) to Prevent Delirium in Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial. Clin Nurs Res. 2026 Jul;35(6):300-311. doi: 10.1177/10547738261445264. Epub 2026 May 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized music and Personalized music plus earplug in people with Critical Illness and Mechanical Ventilation, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence (time frame: Date of study enrollment through 7th day, or date of discharge from ICU.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.