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

NCT04977011 | Completed DMC

• 1 other identifier: MSIRB2018020
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Richmond Agitation Sedation Scale

  3 day

• Richards-Campbell Sleep Scale

  3 day

Study Arms (2)

experimental group

EXPERIMENTAL

30 minutes music intervention for 3 days on bedside

Other: relaxing music

control group

NO INTERVENTION

usually care

Interventions

relaxing music OTHER

30 minutes relaxing music for continuity 3 days since admission

experimental group

Eligibility Criteria

• Age: 20 Years - 102 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Dementia or mental illness are recorded

Sponsors & Collaborators

• Min-Sheng General Hospital: lead

Study Sites (1)

MinSheng General Hospital

Taoyuan District, Taiwan

Location

Related Publications (17)

• 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.

  PMID: 24035670 RESULT

• 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.

  PMID: 23689789 RESULT

• 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.

  PMID: 24963569 RESULT

• 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.

  PMID: 20492047 RESULT

• 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.

  PMID: 30600227 RESULT

• 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.

  PMID: 20492042 RESULT

• 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.

  PMID: 29735284 RESULT

• 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.

  PMID: 21323778 RESULT

• 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.

  PMID: 15840076 RESULT

• 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.

  PMID: 28434475 RESULT

• 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.

  PMID: 27912960 RESULT

• 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.

  PMID: 30057058 RESULT

• 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.

  PMID: 29716903 RESULT

• 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.

  PMID: 20621273 RESULT

• 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.

  PMID: 23245705 RESULT

• 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.

  PMID: 22931483 RESULT

• 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.

  PMID: 11604980 RESULT

MeSH Terms

Conditions

Diabetic Ketoacidosis; Myocardial Ischemia; Stroke; Gastrointestinal Hemorrhage; Acute Kidney Injury; Heart Failure; Wounds and Injuries; Shock, Septic; Respiratory Insufficiency; Pneumonia; Cerebral Hemorrhage; Craniocerebral Trauma; Liver Diseases; Anxiety Disorders; Psychomotor Agitation; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections; Lung Diseases; Intracranial Hemorrhages; Trauma, Nervous System; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Ming-Han Tsai

  Min-Sheng General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 minutes music intervention for 3 days on bedside

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 26, 2021
• Study Start: January 2, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)