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
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
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
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:
PubMed Identifier
24035670
Citation
Aghaie B, Rejeh N, Heravi-Karimooi M, Ebadi A, Moradian ST, Vaismoradi M, Jasper M. Effect of nature-based sound therapy on agitation and anxiety in coronary artery bypass graft patients during the weaning of mechanical ventilation: A randomised clinical trial. Int J Nurs Stud. 2014 Apr;51(4):526-38. doi: 10.1016/j.ijnurstu.2013.08.003. Epub 2013 Aug 29.
Results Reference
result
PubMed Identifier
23689789
Citation
Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
Results Reference
result
PubMed Identifier
24963569
Citation
Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014 Jun 26;370(26):2506-14. doi: 10.1056/NEJMra1208795. No abstract available.
Results Reference
result
PubMed Identifier
20492047
Citation
Dijkstra BM, Gamel C, van der Bijl JJ, Bots ML, Kesecioglu J. The effects of music on physiological responses and sedation scores in sedated, mechanically ventilated patients. J Clin Nurs. 2010 Apr;19(7-8):1030-9. doi: 10.1111/j.1365-2702.2009.02968.x.
Results Reference
result
PubMed Identifier
30600227
Citation
Golino AJ, Leone R, Gollenberg A, Christopher C, Stanger D, Davis TM, Meadows A, Zhang Z, Friesen MA. Impact of an Active Music Therapy Intervention on Intensive Care Patients. Am J Crit Care. 2019 Jan;28(1):48-55. doi: 10.4037/ajcc2019792.
Results Reference
result
PubMed Identifier
20492042
Citation
Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010 Apr;19(7-8):978-87. doi: 10.1111/j.1365-2702.2009.02845.x.
Results Reference
result
PubMed Identifier
29735284
Citation
Johnson K, Fleury J, McClain D. Music intervention to prevent delirium among older patients admitted to a trauma intensive care unit and a trauma orthopaedic unit. Intensive Crit Care Nurs. 2018 Aug;47:7-14. doi: 10.1016/j.iccn.2018.03.007. Epub 2018 May 4.
Results Reference
result
PubMed Identifier
21323778
Citation
Korhan EA, Khorshid L, Uyar M. The effect of music therapy on physiological signs of anxiety in patients receiving mechanical ventilatory support. J Clin Nurs. 2011 Apr;20(7-8):1026-34. doi: 10.1111/j.1365-2702.2010.03434.x. Epub 2011 Feb 16.
Results Reference
result
PubMed Identifier
15840076
Citation
Lee OK, Chung YF, Chan MF, Chan WM. Music and its effect on the physiological responses and anxiety levels of patients receiving mechanical ventilation: a pilot study. J Clin Nurs. 2005 May;14(5):609-20. doi: 10.1111/j.1365-2702.2004.01103.x.
Results Reference
result
PubMed Identifier
28434475
Citation
Lee WP, Wu PY, Lee MY, Ho LH, Shih WM. Music listening alleviates anxiety and physiological responses in patients receiving spinal anesthesia. Complement Ther Med. 2017 Apr;31:8-13. doi: 10.1016/j.ctim.2016.12.006. Epub 2017 Jan 7.
Results Reference
result
PubMed Identifier
27912960
Citation
Liang Z, Ren D, Choi J, Happ MB, Hravnak M, Hoffman LA. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial. Complement Ther Med. 2016 Dec;29:72-77. doi: 10.1016/j.ctim.2016.09.003. Epub 2016 Sep 15.
Results Reference
result
PubMed Identifier
30057058
Citation
Najafi Ghezeljeh T, Mohaddes Ardebili F. Comparing the effect of patients preferred music and Swedish massage on anticipatory anxiety in patients with burn injury: Randomized controlled clinical trial. Complement Ther Clin Pract. 2018 Aug;32:55-60. doi: 10.1016/j.ctcp.2018.05.002. Epub 2018 May 4.
Results Reference
result
PubMed Identifier
29716903
Citation
Papathanassoglou EDE, Hadjibalassi M, Miltiadous P, Lambrinou E, Papastavrou E, Paikousis L, Kyprianou T. Effects of an Integrative Nursing Intervention on Pain in Critically Ill Patients: A Pilot Clinical Trial. Am J Crit Care. 2018 May;27(3):172-185. doi: 10.4037/ajcc2018271.
Results Reference
result
PubMed Identifier
20621273
Citation
Phipps MA, Carroll DL, Tsiantoulas A. Music as a therapeutic intervention on an inpatient neuroscience unit. Complement Ther Clin Pract. 2010 Aug;16(3):138-142. doi: 10.1016/j.ctcp.2009.12.001. Epub 2010 May 15.
Results Reference
result
PubMed Identifier
23245705
Citation
Saadatmand V, Rejeh N, Heravi-Karimooi M, Tadrisi SD, Zayeri F, Vaismoradi M, Jasper M. Effect of nature-based sounds' intervention on agitation, anxiety, and stress in patients under mechanical ventilator support: a randomised controlled trial. Int J Nurs Stud. 2013 Jul;50(7):895-904. doi: 10.1016/j.ijnurstu.2012.11.018. Epub 2012 Dec 14.
Results Reference
result
PubMed Identifier
22931483
Citation
Su CP, Lai HL, Chang ET, Yiin LM, Perng SJ, Chen PW. A randomized controlled trial of the effects of listening to non-commercial music on quality of nocturnal sleep and relaxation indices in patients in medical intensive care unit. J Adv Nurs. 2013 Jun;69(6):1377-89. doi: 10.1111/j.1365-2648.2012.06130.x. Epub 2012 Aug 29.
Results Reference
result
PubMed Identifier
11604980
Citation
Wong HL, Lopez-Nahas V, Molassiotis A. Effects of music therapy on anxiety in ventilator-dependent patients. Heart Lung. 2001 Sep-Oct;30(5):376-87. doi: 10.1067/mhl.2001.118302.
Results Reference
result
Learn more about this trial
Effectiveness of Music Intervention on Anxiety and Physiological Responses in Critical Ill Patient
We'll reach out to this number within 24 hrs