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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977011
• Other study ID #: MSIRB2018020
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: July 2021
• Source: Min-Sheng General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 102 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cerebral Hemorrhage
• Craniocerebral Trauma
• Diabetic Ketoacidosis
• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Head Injury
• Heart Disease, Ischemic
• Heart Diseases
• Heart Failure
• Hemorrhage
• Intracerebral Hemorrhage
• Ketosis
• Liver Diseases
• Myocardial Ischemia
• Pneumonia
• Respiratory Failure
• Respiratory Insufficiency
• Septic Shock
• Stroke
• Trauma
• Wounds and Injuries

Intervention

Other:
• relaxing music
30 minutes relaxing music for continuity 3 days since admission

Locations

Country	Name	City	State
Taiwan	MinSheng General Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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 — View 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 tr — View 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. Review. — View 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. — View 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. — View 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 — View 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 — View 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. — View 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. — View 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. — View 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. — View 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: 1 — View 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. do — View 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. — View 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 Nur — View 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 — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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