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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Behavioral: music


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>30 minutes of listening to music | Behavioral: music<br>* Music intervention for 30 minutes<br>|
| No Intervention: Standard of Care<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
music, cardiac surgery, anxiety