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

Primary Purpose

Diabetic Ketoacidosis, Heart Disease, Ischemic, Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
relaxing music
Sponsored by
Min-Sheng General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Ketoacidosis focused on measuring Music intervention, Anxiety, Agitation, Sleep quality, Intensive Care Unit

Eligibility Criteria

20 Years - 102 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MinSheng General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

30 minutes music intervention for 3 days on bedside

usually care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
July 5, 2021
Last Updated
July 14, 2021
Sponsor
Min-Sheng General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04977011
Brief Title
Effectiveness of Music Intervention on Anxiety and Physiological Responses in Critical Ill Patient
Official Title
Effectiveness of Music Intervention on Anxiety in Critical Ill Patient: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Min-Sheng General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Music intervention, Anxiety, Agitation, Sleep quality, Intensive Care Unit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 minutes music intervention for 3 days on bedside
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
30 minutes music intervention for 3 days on bedside
Arm Title
control group
Arm Type
No Intervention
Arm Description
usually care
Intervention Type
Other
Intervention Name(s)
relaxing music
Intervention Description
30 minutes relaxing music for continuity 3 days since admission
Primary Outcome Measure Information:
Title
Anxiety Visual Analog Scale.
Description
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.
Time Frame
3day
Secondary Outcome Measure Information:
Title
Richmond Agitation Sedation Scale
Description
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).
Time Frame
3 day
Title
Richards-Campbell Sleep Scale
Description
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.
Time Frame
3 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
102 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Han Tsai
Organizational Affiliation
Min-Sheng General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
MinSheng General Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effectiveness of Music Intervention on Anxiety and Physiological Responses in Critical Ill Patient

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