NCT03095443

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

March 23, 2017

Last Update Submit

April 16, 2019

Conditions

Delirium

Keywords

DeliriumCritical IllnessMusic Therapy

Outcome Measures

Primary Outcomes (3)

  • Recruitment rates

    the number of participants approached and their rates of consent

    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

    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.

    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

    Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days

Study Arms (3)

Personalized Music

EXPERIMENTAL

Receives personalized playlist twice a day.

Other: Music Therapy - Personalized Playlist

Non Personalized Music

ACTIVE COMPARATOR

Receives standardized low beats per minute playlist twice a day.

Other: Music Therapy - Standard Playlist

Attention Control

ACTIVE COMPARATOR

Receives audio-book twice a day.

Other: Attention Control

Interventions

Music Therapy - Personalized PlaylistOTHER

Participant receives personalized playlist.

Personalized Music
Music Therapy - Standard PlaylistOTHER

Participant receives a standard low beats per minute playlist.

Non Personalized Music
Attention ControlOTHER

Participant receives an audio-book.

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • English speaking
  • admitted to the intensive care unit (medical or surgical)
  • receiving mechanical ventilation

You may not qualify if:

  • 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
  • aphasic stroke
  • coma after cardiac arrest/hypothermia protocol
  • pregnant or nursing
  • prisoners
  • patients enrolled in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 29187230DERIVED

MeSH Terms

Conditions

DeliriumCritical Illness

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 29, 2017

Study Start

December 1, 2016

Primary Completion

October 31, 2017

Study Completion

December 31, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)