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CompletedNCT04977011Updated Jul 26, 2021

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

An interventional study of relaxing music in Diabetic Ketoacidosis, Heart Disease, Ischemic and Stroke, sponsored by Min-Sheng General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 102 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-26.

Sponsored by Min-Sheng General Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jan 2019, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
20 Years to 102 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 196 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Min-Sheng General Hospital is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 102 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Dementia or mental illness are recorded
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
196 participants (actual)

Study arms

  • Experimental
    experimental group

    30 minutes music intervention for 3 days on bedside

    Other: relaxing music

  • No intervention
    control group

    usually care

Interventions

  • Otherrelaxing music

    30 minutes relaxing music for continuity 3 days since admission

06

What researchers measure

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.

    Time frame: 3day

Secondary outcomes

  1. 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).

    Time frame: 3 day

  2. 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.

    Time frame: 3 day

07

Study locations

1 site
  • MinSheng General Hospital
    Taoyuan, Taiwan
08

References and documents

Publications

  • 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. PubMed 24035670 ↗
  • 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. PubMed 23689789 ↗
  • 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. PubMed 24963569 ↗
  • 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. PubMed 20492047 ↗
  • 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. PubMed 30600227 ↗
  • 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. PubMed 20492042 ↗
  • 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. PubMed 29735284 ↗
  • 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. PubMed 21323778 ↗
  • 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. PubMed 15840076 ↗
  • 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. PubMed 28434475 ↗
  • 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. PubMed 27912960 ↗
  • 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. PubMed 30057058 ↗
  • 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. PubMed 29716903 ↗
  • 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. PubMed 20621273 ↗
  • 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. PubMed 23245705 ↗
  • 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. PubMed 22931483 ↗
  • 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. PubMed 11604980 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04977011
Lead sponsor
Min-Sheng General Hospital
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
Jan 2, 2019
Primary completion
Jun 30, 2019
Completion
Jul 30, 2019
Last update
Jul 26, 2021

Study contacts

Ming-Han Tsai
study chair · Min-Sheng General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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