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NCT Number: NCT04551469

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

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.

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Key information

Conditions

Cardiac Surgery Anxiety Disorders Mental Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Behavioral

Music intervention for 30 minutes

Primary outcomes

  1. Change in Serum Cortisol

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

    micrograms per deciliter

Secondary outcomes

  1. Anxiety

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

    Spielberger State Anxiety Scale (STAI) -2 0 to 80 with higher score more Anxiety.

  2. Perceived Pain Level

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

    Visual Analogue Pain Scale- 0 to 10 with 0 = no pain to 10=worst pain.

  3. Blood Pressure

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

    mm Hg

  4. Heart Rate

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

    beats per minute

  5. Respirations

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

    breaths per minute

  6. Serum Immunoglobulin A

    Time frame: Change in serum immunoglobulin A before and 30 minutes after start of intervention period

    mg per deciliter

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 16, 2020
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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