DeliriumDDMNCT03095443
Decreasing Delirium Through Music
A study testing Music Therapy - Personalized Playlist and Music Therapy - Standard Playlist in people with Delirium, run by Indiana University at 1 site in United States.
Trial summary
DDM is a study designed to Test the efficacy of personalized music therapy in reducing delirium incidence and severity among patients admitted to the Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Music Therapy - Personalized Playlist and Music Therapy - Standard Playlist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- English speaking
- admitted to the intensive care unit (medical or surgical)
- receiving mechanical ventilation
Who cannot join
- history of dementia
- psychiatric illness which is not well controlled
- alcohol withdrawal symptoms/concern for withdrawal
- suspected or confirmed drug intoxication/overdose
- traumatic brain injury
- hearing or vision impairment including legal blindness
Show all 11Show fewer
- aphasic stroke
- coma after cardiac arrest/hypothermia protocol
- pregnant or nursing
- prisoners
- patients enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
DDM is a study designed to Test the efficacy of personalized music therapy in reducing delirium incidence and severity among patients admitted to the Intensive Care Unit.
Read the detailed description
Over 1 million adults are admitted to the intensive care unit and placed on mechanical ventilation on an annual basis. Intravenous sedatives and analgesics are commonly administered to these patients to reduce pain and anxiety. While the recent reduction in benzodiazepine usage has helped reduced ICU-related acute brain dysfunction (delirium), up to 80% of ventilated patients still develop acute brain failure. This is characterized by disturbance of consciousness with reduced ability to focus, sustain or shift attention, occurring over a short period of time and fluctuating over the course of a day.
Acute brain dysfunction has both short-term and long-term health impacts. It is associated with increased hospital length of stay, increased in-hospital mortality and post-discharge mortality as well increased health-care costs. Patients who experience delirium are at greater risk for post-discharge institutionalization and newly acquired cognitive impairment similar to dementia.
Despite the prevalence and morbidity associated with delirium, there is a scarcity of effective pharmacological and non-pharmacological interventions to prevent and treat this condition. While music therapy has shown to reduce anxiety and stress in cancer and dementia patients, these studies were performed outside the intensive care unit. It is hypothesized that music lowers inflammatory mediators such as cytokines and cortisol. Delirium pathophysiology similar to anxiety has a strong inflammatory component with excess of pro-inflammatory cytokines such as interleukins 1, 6, and 8. Given the beneficial effects of music in reducing inflammatory mediators, it stands to reason that such intervention will have a beneficial impact on reducing delirium.
The investigators propose a randomized, three-group (personalized music intervention versus generic music intervention versus attention control) trial to test the feasibility and efficacy of music therapy in reducing delirium incidence, duration, and severity among critically ill patients in the ICU.
Our study focuses on the effect of music therapy on the incidence and severity of delirium in the intensive care unit at a large urban academic health center.
The investigators hypothesize that music therapy will lead to reduced levels of anxiety, delirium and need for sedating medications, leading to shorter hospital stays.
- Conditions
- Delirium
- Being tested
- Music Therapy - Personalized Playlist, Music Therapy - Standard Playlist, Attention Control
- Keywords
- Delirium, Critical Illness, Music Therapy
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy - Personalized PlaylistOther
Participant receives personalized playlist.
Music Therapy - Standard PlaylistOther
Participant receives a standard low beats per minute playlist.
Attention ControlOther
Participant receives an audio-book.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Music | Experimental | Receives personalized playlist twice a day. Receives: Other: Music Therapy - Personalized Playlist |
| Non Personalized Music | Active comparator | Receives standardized low beats per minute playlist twice a day. Receives: Other: Music Therapy - Standard Playlist |
| Attention Control | Active comparator | Receives audio-book twice a day. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
the number of participants approached and their rates of consent
Measured: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Intervention adherence
number of listening sessions completed per patient
Measured: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Participant retention
Number of patients who complete the study.
Measured: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Secondary outcomes (1)
Estimate the potential effect size
Patient-preferred music association with reducing delirium incidence as measured by CAM-ICU.
Measured: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Dec 2016
- Primary completion31 Oct 2017
- Study completion31 Dec 2018
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 DeliriumStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Babar Khan, MD, MS, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095443
- Sponsor's protocol ID
- 1608887741
- Acronym
- DDM
- Status last verified
- Apr 2019
- First submitted
- 23 Mar 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.
PubMed 29187230
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Delirium Through Music
- ClinicalTrials.gov ID
- NCT03095443
- Acronym / sponsor ID
- DDM / 1608887741
- Conditions
- Delirium
- Keywords
- Delirium, Critical Illness, Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Regenstrief Institute, Inc.
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Mar 2017 (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.
DDM is a study designed to Test the efficacy of personalized music therapy in reducing delirium incidence and severity among patients admitted to the Intensive Care Unit.
Detailed description
Over 1 million adults are admitted to the intensive care unit and placed on mechanical ventilation on an annual basis. Intravenous sedatives and analgesics are commonly administered to these patients to reduce pain and anxiety. While the recent reduction in benzodiazepine usage has helped reduced ICU-related acute brain dysfunction (delirium), up to 80% of ventilated patients still develop acute brain failure. This is characterized by disturbance of consciousness with reduced ability to focus, sustain or shift attention, occurring over a short period of time and fluctuating over the course of a day.
Acute brain dysfunction has both short-term and long-term health impacts. It is associated with increased hospital length of stay, increased in-hospital mortality and post-discharge mortality as well increased health-care costs. Patients who experience delirium are at greater risk for post-discharge institutionalization and newly acquired cognitive impairment similar to dementia.
Despite the prevalence and morbidity associated with delirium, there is a scarcity of effective pharmacological and non-pharmacological interventions to prevent and treat this condition. While music therapy has shown to reduce anxiety and stress in cancer and dementia patients, these studies were performed outside the intensive care unit. It is hypothesized that music lowers inflammatory mediators such as cytokines and cortisol. Delirium pathophysiology similar to anxiety has a strong inflammatory component with excess of pro-inflammatory cytokines such as interleukins 1, 6, and 8. Given the beneficial effects of music in reducing inflammatory mediators, it stands to reason that such intervention will have a beneficial impact on reducing delirium.
The investigators propose a randomized, three-group (personalized music intervention versus generic music intervention versus attention control) trial to test the feasibility and efficacy of music therapy in reducing delirium incidence, duration, and severity among critically ill patients in the ICU.
Our study focuses on the effect of music therapy on the incidence and severity of delirium in the intensive care unit at a large urban academic health center.
The investigators hypothesize that music therapy will lead to reduced levels of anxiety, delirium and need for sedating medications, leading to shorter hospital stays.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Music | Experimental | Other: Music Therapy - Personalized PlaylistReceives personalized playlist twice a day. |
| Non Personalized Music | Active comparator | Other: Music Therapy - Standard PlaylistReceives standardized low beats per minute playlist twice a day. |
| Attention Control | Active comparator | Other: Attention ControlReceives audio-book twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- English speaking
- admitted to the intensive care unit (medical or surgical)
- receiving mechanical ventilation
Key exclusion criteria (11 listed)
- history of dementia
- psychiatric illness which is not well controlled
- alcohol withdrawal symptoms/concern for withdrawal
- suspected or confirmed drug intoxication/overdose
- traumatic brain injury
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 |
|---|---|---|
| Music Therapy - Personalized PlaylistParticipant receives personalized playlist. | Other | Personalized Music |
| Music Therapy - Standard PlaylistParticipant receives a standard low beats per minute playlist. | Other | Non Personalized Music |
| Attention ControlParticipant receives an audio-book. | Other | Attention Control |
Primary outcome
Recruitment rates
Time frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
the number of participants approached and their rates of consent
Intervention adherence
Time frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
number of listening sessions completed per patient
Participant retention
Time frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Number of patients who complete the study.
1 secondary outcome
Estimate the potential effect size
Time frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 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 17 Apr 2019.
- Derived from this study: PubMed 29187230Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.
- Individual participant dataSharing planned: No
Related trials for Delirium
Active, not recruiting
TaVNS for Delirium
Delirium
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
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 Therapy - Personalized Playlist and Music Therapy - Standard Playlist in people with Delirium, run by Indiana University at 1 site in United States.
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 4 inclusion and 11 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 17 Apr 2019. 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 United States. 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?
Recruitment rates (time frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days). The study lists 3 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 NCT03095443, 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 17 Apr 2019.