Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT03156205
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Patient-Directed Interactive Music Therapy on Sleep, Delirium and Melatonin Levels is Critically Ill Elderly Patients
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Effects of Patient-Directed Interactive Music Therapy on Sleep, Delirium and Melatonin Levels is Critically Ill Elderly Patients
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: