Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551469
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2020-09-03
Brief Title:
A Randomized Clinical Trial to Measure Efficacy of Music on Cardiac Surgery Patients
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Randomized Clinical Trial to Measure Efficacy of Music on Cardiac Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 psychologicalphysical 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
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 psychologicalphysical 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None