Clinical trial NCT04551469: A Randomized Clinical Trial to Measure Efficacy of Music on Cardiac Surgery Patients
Official title: A Randomized Clinical Trial to Measure Efficacy of Music on Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Keywords: music
cardiac surgery
anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Serum Cortisol
timeFrame: Change in serum cortisol before and 30 minutes after start of intervention period
Secondary outcomes:
measure: Anxiety
timeFrame: Change in state anxiety before and 30 minutes after start of intervention period
measure: Perceived Pain Level
timeFrame: Change in pain level before and 30 minutes after start of intervention period
measure: Blood Pressure
timeFrame: Change in blood pressure before and 30 minutes after start of intervention period
measure: Heart Rate
timeFrame: Change in heart rate before and 30 minutes after start of intervention period
measure: Respirations
timeFrame: Change in respirations before and 30 minutes after start of intervention period
measure: Serum Immunoglobulin A
timeFrame: Change in serum immunoglobulin A before and 30 minutes after start of intervention period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.