A Randomized Clinical Trial to Measure Efficacy of Music on Cardiac Surgery Patients

NCT04551469 | Active Not Recruiting

• 1 other identifier: MusicCS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery involves both physical and psychological stress for patients from time of decision to the recovery period. The physical aspects and the impact on the psychological experience makes the post-operative period a difficult time for patients. Patients often experience emotional distress, uncertainty, and fear. A non-pharmacological intervention of music may affect the patient's perception of early recovery with little to no side effects. Current research has demonstrated efficacy in psychological and physical responses. there is limited data on the endocrinologic (cortisol) and immunologic biomarkers Immunoglobulin A to a music intervention. Therefore, the purpose of this study is to measure both psychological/physical response and biomarkers pre and post a 30-minute music intervention compared to standard of care experience A randomized, placebo-controlled, pre-post clinical trial will be initiated to demonstrate the effect that music has on the primary outcome of serum cortisol and secondary outcomes of anxiety, pain, blood pressure, heart rate, respirations, and Immunoglobulin A in adult patients after cardiac surgery.

Conditions

Cardiac Surgery

Keywords

music; cardiac surgery; anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Serum Cortisol

  micrograms per deciliter

  Change in serum cortisol before and 30 minutes after start of intervention period

Secondary Outcomes (6)

• Anxiety

  Change in state anxiety before and 30 minutes after start of intervention period

• Perceived Pain Level

  Change in pain level before and 30 minutes after start of intervention period

• Blood Pressure

  Change in blood pressure before and 30 minutes after start of intervention period

• Heart Rate

  Change in heart rate before and 30 minutes after start of intervention period

• Respirations

  Change in respirations before and 30 minutes after start of intervention period

Study Arms (2)

Treatment Arm

EXPERIMENTAL

30 minutes of listening to music

Behavioral: music

Standard of Care

NO INTERVENTION

actual sounds of the intensive care unit environment

Interventions

music BEHAVIORAL

Music intervention for 30 minutes

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the Cardiac Surgical Intensive Care Unit or the Cardiac Surgical Step Down Unit after undergoing heart valve replacement/repair and/or coronary artery bypass surgery, or aortic repair over the age of 18 years, hemodynamically stable, extubated and able to hear music.

You may not qualify if:

• Patients that are deaf, hemodynamically unstable, intubated, and on infectious disease precautions after surgery.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• Wahbeh H, Haywood A, Kaufman K, Zwickey H. Mind-Body Medicine and Immune System Outcomes: A Systematic Review. Open Complement Med J. 2009;1:25-34. doi: 10.2174/1876391X00901010025.

  PMID: 23227136 BACKGROUND

• Finn S, Fancourt D. The biological impact of listening to music in clinical and nonclinical settings: A systematic review. Prog Brain Res. 2018;237:173-200. doi: 10.1016/bs.pbr.2018.03.007. Epub 2018 May 1.

  PMID: 29779734 BACKGROUND

• Nilsson U. The effect of music intervention in stress response to cardiac surgery in a randomized clinical trial. Heart Lung. 2009 May-Jun;38(3):201-7. doi: 10.1016/j.hrtlng.2008.07.008. Epub 2008 Oct 5.

  PMID: 19486788 BACKGROUND

• 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 BACKGROUND

• Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.

  PMID: 26365452 BACKGROUND

• Heidari S, Babaii A, Abbasinia M, Shamali M, Abbasi M, Rezaei M. The Effect of Music on Anxiety and Cardiovascular Indices in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e31157. doi: 10.17795/nmsjournal31157. Epub 2015 Dec 1.

  PMID: 26835471 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse researcher

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 16, 2020
• Study Start: July 1, 2021
• Primary Completion: May 10, 2024
• Study Completion: December 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)