NCT03156205

Brief Summary

(Background) Adults in intensive care units (ICU), especially elderly patients often suffer from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as pain, inflammation, and anxiety. Delirium, acute cognitive dysfunction, which result from sleep deprivation often leads to prolonged ICU stay and increase medical costs. Pharmacological and non-pharmacological interventions have been tried to improve the duration and quality of sleep and to maintain diurnal cycle. (Purpose) The aim of this study is to assess the efficacy of patient-driven interactive music intervention on sleep promotion in critically ill elderly adults. Delirium and urine/blood melatonin level will be assessed, too. In this study, randomized controlled trial for 50 elderly ICU patients who aged over 65 years in each group will be proceeded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 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

March 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

May 15, 2017

Last Update Submit

November 9, 2017

Conditions

Critically Ill Adult Patients in Intensive Care Units

Keywords

critically ill patientsmusic therapysleepdeliriummelatoninelderly

Outcome Measures

Primary Outcomes (1)

  • Richards-Campbell Sleep Questionnaire (RCSQ)

    This scale evaluates sleep quality including perceptions of depth of sleep, sleep onset latency, number of awakenings, etc. It was designed as an outcome measure for assessment of the perception of sleep in critically ill patients.

    RCSQ will be measured for 3 days. (once/day)

Study Arms (3)

Interactive Music Therapy

EXPERIMENTAL
Behavioral: interactive music therapy

passive music listening

OTHER
Behavioral: passive music listening

passive earphone-use

OTHER
Behavioral: passive earphone-use

Interventions

interactive music therapyBEHAVIORAL

For the interactive music therapy intervention group, each patient received individual interactive music therapy sessions administered by professional music therapists during daytime; the patient participated in listening to music predetermined based on his/her preference during night time.

Interactive Music Therapy
passive music listeningBEHAVIORAL

For the passive music listening group, each patient participated in music listening during night time without involving in interactive music therapy sessions during daytime.

passive music listening
passive earphone-useBEHAVIORAL

For the passive earphone use group (control group), each participant used headphone and eye mask without music listening at night time.

passive earphone-use

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients aged over 65
  • ASA(american society of anesthesiologists) class I-III

You may not qualify if:

  • patients who had difficulties in communication
  • history of neurological or psychiatric disorders, dementia, or alcohol use disorder.
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

  • Kim J, Choi D, Yeo MS, Yoo GE, Kim SJ, Na S. Effects of Patient-Directed Interactive Music Therapy on Sleep Quality in Postoperative Elderly Patients: A Randomized-Controlled Trial. Nat Sci Sleep. 2020 Oct 21;12:791-800. doi: 10.2147/NSS.S286375. eCollection 2020.

    PMID: 33117015DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

March 2, 2017

Primary Completion

September 25, 2017

Study Completion

September 25, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)