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Effects of Patient-Directed Interactive Music Therapy on Sleep, Delirium and Melatonin Levels is Critically Ill Elderly Patients

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Yonsei University

Status

Completed

Conditions

Critically Ill Adult Patients in Intensive Care Units

Treatments

Behavioral: passive music listening
Behavioral: passive earphone-use
Behavioral: interactive music therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03156205
4-2016-0873

Details and patient eligibility

About

(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.

Full description

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.

Primary outcome: Richards-Campbell Sleep Questionnaire

Secondary outcome: Confusion Assessment Method - ICU, blood/urine melatonin level, ICU stay, Hospital stay, and mechanical ventilation duration / Delirium, acute cognitive dysfunction, which result from sleep deprivation often leads to prolonged ICU stay and increase medical costs. Elderly patients in ICU often suffer from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as pain, inflammation, and anxiety. Pharmacological and non-pharmacological interventions have been tried to improve the duration and quality of sleep and to maintain diurnal cycle. If interactive music therapy could improve quality of sleep and reduce incidence and severity of delirium in this patient population, it will be a good way to reduce medical costs without significant complications.

Expectation: There have been many trials to reduce delirium incidence and recover sleep patterns in ICU patients. If we could find interactive music therapy improve quality of sleep and reduce incidence and severity of delirium in this patient population, it will be a good way to reduce medical costs without significant complications. In addition, rhythm in music can be a appropriate support for respiration and motor function in elderly ICU patients.

Enrollment

152 patients

Sex

All

Ages

60 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

152 participants in 3 patient groups

Interactive Music Therapy
Experimental group
Treatment:
Behavioral: interactive music therapy
passive music listening
Other group
Treatment:
Behavioral: passive music listening
passive earphone-use
Other group
Treatment:
Behavioral: passive earphone-use

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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