Effectiveness of Music Intervention on Anxiety and Physiological Responses in Critical Ill Patient

Study Overview
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Brief Summary
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Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in Intensive Care Unit (ICU) is still unknown. The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU. This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety. Agitation Sedation Scale, sleep quality and physical parameters were selected to collect as secondary outcomes.There was no significant difference between the groups at baseline. The results of this study support that music can reduce anxiety and agitation levels in ICU's patient. Nurses can incorporate this intervention into the daily care in order to reduce the discomfort of patients.

Detailed Description
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Background:Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in ICU is still unknown. Objectives: The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU. Methods: This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety measured by Visual Analog Scale. Richmond Agitation Sedation Scale, Richards-Campbell Sleep Scale and their physical parameters were selected to collect the secondary outcomes.

Official Title
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Effectiveness of Music Intervention on Anxiety in Critical Ill Patient: Randomized Controlled Trial

Conditions
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Diabetic Ketoacidosis, Heart Disease, Ischemic, Stroke, GastroIntestinal Bleeding, Acute Kidney Injury, Heart Failure, Trauma, Septic Shock, Respiratory Failure, Pneumonia, Intracerebral Hemorrhage, Head Injury, Liver Diseases

Intervention / Treatment
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* Other: relaxing music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20 years or older and staying in an intensive care unit. Patients within 24 hours of admission (Acute Physiology And Chronic Health Evaluation, APACHE II score) ≦25 points. Can express their intentions by writing or shaking their heads. Can communicate in Mandarin, Taiwanese, Hakka or English. After explaining the purpose of the research, agree to participate and fill out the consent form. Exclusion Criteria: Dementia or mental illness are recorded

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 102 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 30 minutes music intervention for 3 days on bedside
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>30 minutes music intervention for 3 days on bedside | Other: relaxing music<br>* 30 minutes relaxing music for continuity 3 days since admission<br>|
| No Intervention: control group<br>usually care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Visual Analog Scale. | The Visual Analogue Scale for Anxiety (VASA) is a line 10 centimetres in length with not at all anxious and very anxious at the left and right extremes respectively. | 3day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richmond Agitation Sedation Scale | The Richmond Agitation-Sedation Scale (RASS) was developed in a collaborative effort with practitioners representing critical care physicians, nurses, and pharmacists. RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 [combative]), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5). | 3 day | 
| Richards-Campbell Sleep Scale | The RCSQ is used in order to assess sleep quality in eligible ICU patients. The RCSQ is a six-item self-report questionnaire that is used in order to assess perceived sleep depth, sleep latency (time to fall asleep), and number of awakenings, as well as sleep efficiency, quality and perceived nighttime noise. Each RCSQ item is scored on a visual analog scale ranging from 0 mm to 100 mm, with higher scores representing better sleep. The mean score of the six items is known as the total score and represents the overall perception of sleep. | 3 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music intervention, Anxiety, Agitation, Sleep quality, Intensive Care Unit