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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Behavioral: music

Detailed Description

One hundred-twelve subjects will be enrolled, 56 subjects in the treatment and 56 subjects in the standard of care group. It was estimated this sample size would be needed to detect a medium effects size of .30 with an alpha set at a level of .05.

Patients, who agree to participate, will be randomly allocated to one of two groups, treatment and standard of care group using a computer-generated randomization scheme.

On post-operative day one, two or three, a 30-minute music period will be used through personal headphones and a MP3 device. Music will be a selection that is symphonic music that has no dramatic changes. The standard of care group will listen to environmental sounds in the Cardiac Surgical Intensive Care Unit.

Psychological, and physical responses as well as biomarkers will be collected pre and then 30 minutes after the start of the intervention period in both groups. The psychological response will be assessed by the Spielberger State Anxiety Scale to measure state anxiety and a visual analogue scale for measurement of pain. Physical responses will be collected that includes Blood pressure in mmHg, heart rate in beats per minute and respirations in beats per minute. The biomarkers collected will be serum cortisol measured in micrograms per deciliter and Immunoglobulin in milligrams per deciliter.

Descriptive statistics will be used to describe the sample and the outcomes measure will be compared using a student t-test.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane L Carroll, PhD; Phone Number: 617-724-4934; Email: dcarroll3@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Diane L Carroll, PhD, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 30 minutes of listening to music	Behavioral: music; Music intervention for 30 minutes
No Intervention: Standard of Care; actual sounds of the intensive care unit environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Cortisol	micrograms per deciliter	Change in serum cortisol before and 30 minutes after start of intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Spielberger State Anxiety Scale (STAI) -2 0 to 80 with higher score more Anxiety.	Change in state anxiety before and 30 minutes after start of intervention period
Perceived Pain Level	Visual Analogue Pain Scale- 0 to 10 with 0 = no pain to 10=worst pain.	Change in pain level before and 30 minutes after start of intervention period
Blood Pressure	mm Hg	Change in blood pressure before and 30 minutes after start of intervention period
Heart Rate	beats per minute	Change in heart rate before and 30 minutes after start of intervention period
Respirations	breaths per minute	Change in respirations before and 30 minutes after start of intervention period
Serum Immunoglobulin A	mg per deciliter	Change in serum immunoglobulin A before and 30 minutes after start of intervention period

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; anxiety; music
• Other Study ID Numbers: MusicCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No