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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04551469
• Other study ID #: MusicCS
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Behavioral:
• music
Music intervention for 30 minutes

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Cortisol	micrograms per deciliter	Change in serum cortisol before and 30 minutes after start of intervention period
Secondary	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
Secondary	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
Secondary	Blood Pressure	mm Hg	Change in blood pressure before and 30 minutes after start of intervention period
Secondary	Heart Rate	beats per minute	Change in heart rate before and 30 minutes after start of intervention period
Secondary	Respirations	breaths per minute	Change in respirations before and 30 minutes after start of intervention period
Secondary	Serum Immunoglobulin A	mg per deciliter	Change in serum immunoglobulin A before and 30 minutes after start of intervention period