DeliriumNCT05082623
The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters
A study testing Music and Earplug in people with Delirium and Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Music and Earplug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2020to Oct 2021
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years,
- Admitted to the ICU as of the start of the study and planned to be followed up in the ICU for at least 24 hours,
- Needing invasive MV for at least 24 hours,
- Pre-deliric score > 20%
- At least one positive delirium according to CAM-ICU,
- GCS score > 8,
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- RASS score ≥ -3,
- Hemodynamically stable,
- CPOT score ≥ 3
Who cannot join
- Hearing or vision problems,
- Diagnosed with psychiatric illness,
- Diagnosed with dementia,
- Having acute neurological injury,
- Alcohol/drug poisoning
- Hemodynamically unstable and treated with high-dose inotropic/vasopressor medication,
Show all 12Show fewer
- Pregnant,
- Planned to be followed in ICU for less than 24 hours,
- Does not need MV,
- GCS score ≤ 8,
- RASS score < -3,
- Patients referred from another ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters in Patients Receiving Ventilator Support in Intensive Care
The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs.
Read the detailed description
Delirium is an acute disorder of consciousness and cognitive function that occurs frequently in critical care settings. Many critically ill patients (e.g., up to 80% of patients) experience ICU delirium due to underlying medical or surgical health problems, recent surgical or other invasive procedures, medications, or various noxious stimuli (e.g., underlying psychological stressors, mechanical ventilation [MV], noise, light, patient care interactions, and drug-induced sleep disruption or deprivation). Delirium contributes to adverse outcomes such as increased mortality and morbidity, longer length of ICU stays, prolonged MV, costlier hospitalizations, and cognitive impairment after hospital discharge. The Society of Critical Care Medicine (SCMM) Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PADIS) recommend non-pharmacological interventions of preventing delirium and other symptoms. Music, which is one of the non-pharmacological applications, is one of the cognitive-behavioral treatment methods applied in the field of ICU as in many other fields. Music is easy method to apply and has no side effects and contributes to physical, psychological, emotional and spiritual healing. In the literature, it is seen that music intervention studies applied to patients followed in the ICU mostly focus on the effects on anxiety, pain, non-invasive ventilation tolerance, and stress response (heart rate, blood pressure, respiratory rate). The relationship between intensive care delirium and all these symptoms (pain, agitation, anxiety, stress response, etc.) and their interaction with each other have been clarified in the light of evidence-based guidelines and studies. Therefore, the aim of this study is to examine the effects of music applied to patients followed in the ICU with MV support on delirium, pain, need for sedation, anxiety and vital parameters.
- Being tested
- Music, Earplug
- Keywords
- delirium, intensive care, music
- Medical subject headings
- Delirium, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music medicine
EarplugOther
Earplug with noise cancelling
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | "MusiCure®" compositions specially composed for the music group will be performed twice a day, between 10.00-11.00 a.m. and 14.00-15.00 p.m., for five days with headphones and a music player. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the music application, at the 30th minute after starting the music, and at the 60th minute after the end of the music, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools. Receives: Other: Music |
| Earplug group | Active comparator | In this group, patients will be given only earplugs. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the intervention, at the 30th minute after starting intervention, and at the 60th minute after the end of the intervention, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools. Receives: Other: Earplug |
| Control group | No intervention | The control group involves neither music intervention nor using earplug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
The delirium event assessed twice daily by trained research nurse using the CAM-ICU. The diagnosis of delirium is based on the presence of two major criteria (i.e. acute or fluctuating onset plus lack of attention) and at least one of the minor criteria (disorganized thinking or altered consciousness level).
Measured: Date of study enrollment through 12 months.
Secondary outcomes (8)
Delirium severity
In case of positive delirium, its severity assessed twice daily by trained research nurse using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Pain severity
Pain assessed by trained research nurse utilizing the Critical Care Pain Observation Tool (CPOT) a valid and reliable instrument in critically ill patients with and without delirium. The CPOT has 4 components: facial expression, body movements, muscle tension, and compliance with the ventilator for intubated patients or vocalization for extubated patients. Each component is scored from 0 to 2 with a possible total score ranging from 0 to 8. A CPOT ≥ 3 is indicative of significant pain.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Need of sedation
Sedation level assessed by trained research nurse using the 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.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Anxiety level
Anxiety level assessed by trained research nurse using Face Anxiety Scale. The scale is composed of five face types. The face type in the left-hand corner indicates an absence of anxiety, while anxiety increases towards the faces in the right-hand corner. When patient scores were three or above, their anxiety was determined to be medium to high.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Systolic/diastolic blood pressure
Changes in the systolic/diastolic blood pressure (mm/Hg). Blood pressure was recorded from monitor of patient.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Heart rate
Changes in the heart rate. Heart rate was measured as number of heartbeats in a per minute from monitor of patient.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Respiratory rate
Changes in the respiratory rate. Respiratory rate was measured as number of breaths in a per minute from monitor of patient.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Oxygen saturation
Changes in the oxygen saturation. Saturation was recorded from monitor of patient.
Measured: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start14 Sep 2020
- Primary completion14 Sep 2021
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ege 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öznur ERBAY DALLI, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082623
- Sponsor's protocol ID
- Music in intensive care
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters in Patients Receiving Ventilator Support in Intensive Care
- ClinicalTrials.gov ID
- NCT05082623
- Acronym / sponsor ID
- Music in intensive care
- Keywords
- delirium, intensive care, music
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 19 Oct 2021 (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.
The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs.
Detailed description
Delirium is an acute disorder of consciousness and cognitive function that occurs frequently in critical care settings. Many critically ill patients (e.g., up to 80% of patients) experience ICU delirium due to underlying medical or surgical health problems, recent surgical or other invasive procedures, medications, or various noxious stimuli (e.g., underlying psychological stressors, mechanical ventilation [MV], noise, light, patient care interactions, and drug-induced sleep disruption or deprivation). Delirium contributes to adverse outcomes such as increased mortality and morbidity, longer length of ICU stays, prolonged MV, costlier hospitalizations, and cognitive impairment after hospital discharge. The Society of Critical Care Medicine (SCMM) Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PADIS) recommend non-pharmacological interventions of preventing delirium and other symptoms. Music, which is one of the non-pharmacological applications, is one of the cognitive-behavioral treatment methods applied in the field of ICU as in many other fields. Music is easy method to apply and has no side effects and contributes to physical, psychological, emotional and spiritual healing. In the literature, it is seen that music intervention studies applied to patients followed in the ICU mostly focus on the effects on anxiety, pain, non-invasive ventilation tolerance, and stress response (heart rate, blood pressure, respiratory rate). The relationship between intensive care delirium and all these symptoms (pain, agitation, anxiety, stress response, etc.) and their interaction with each other have been clarified in the light of evidence-based guidelines and studies. Therefore, the aim of this study is to examine the effects of music applied to patients followed in the ICU with MV support on delirium, pain, need for sedation, anxiety and vital parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: Music"MusiCure®" compositions specially composed for the music group will be performed twice a day, between 10.00-11.00 a.m. and 14.00-15.00 p.m., for five days with headphones and a music player. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the music application, at the 30th minute after starting the music, and at the 60th minute after the end of the music, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools. |
| Earplug group | Active comparator | Other: EarplugIn this group, patients will be given only earplugs. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the intervention, at the 30th minute after starting intervention, and at the 60th minute after the end of the intervention, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools. |
| Control group | No intervention | –The control group involves neither music intervention nor using earplug. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years,
- Admitted to the ICU as of the start of the study and planned to be followed up in the ICU for at least 24 hours,
- Needing invasive MV for at least 24 hours,
- Pre-deliric score > 20%
- At least one positive delirium according to CAM-ICU,
Key exclusion criteria (12 listed)
- Hearing or vision problems,
- Diagnosed with psychiatric illness,
- Diagnosed with dementia,
- Having acute neurological injury,
- Alcohol/drug poisoning
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 |
|---|---|---|
| MusicMusic medicine | Other | Music group |
| EarplugEarplug with noise cancelling | Other | Earplug group |
Primary outcome
Delirium
Time frame: Date of study enrollment through 12 months.
The delirium event assessed twice daily by trained research nurse using the CAM-ICU. The diagnosis of delirium is based on the presence of two major criteria (i.e. acute or fluctuating onset plus lack of attention) and at least one of the minor criteria (disorganized thinking or altered consciousness level).
8 secondary outcomes
Delirium severity
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Pain severity
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Need of sedation
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Anxiety level
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Systolic/diastolic blood pressure
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Heart rate
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Respiratory rate
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Oxygen saturation
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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 Music and Earplug in people with Delirium and Pain, run by Ege University at 1 site in Turkey (Türkiye).
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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 (time frame: Date of study enrollment through 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2021.