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

Not Applicable

Completed

• Conditions: Critically Ill Adult Patients in Intensive Care Units
• Interventions: Behavioral: passive earphone-use; Behavioral: passive music listening; Behavioral: interactive music therapy

• Registration Number: NCT03156205
• Lead Sponsor: Yonsei University

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.

Detailed 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.

Study Timeline

• Study Start: 2017-03-02
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Primary Completion: 2017-09-25
• Study Completion: 2017-09-25
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
passive earphone-use	passive earphone-use	-
passive music listening	passive music listening	-
Interactive Music Therapy	interactive music therapy	-

Primary Outcome Measures

Name	Time	Method
Richards-Campbell Sleep Questionnaire (RCSQ)	RCSQ will be measured for 3 days. (once/day)	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of