Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536504
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress Mood Pain and Biomarkers in Neurosurgical Patients Music-STAR Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress Mood Pain and Biomarkers in Neurosurgical Patients Music-STAR Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study plans to enroll a total of 132 patients and 30 distinct providers The goal of this study is to measure pre- intra- and post-intervention changes in patients vital signs BP HR HRV MAP serum- and plasma-level biomarkers by proteomics analysis including but not limited to interleukin-6 cortisol ACTH oxytocin dopamine epinephrine norepinephrine B-endorphin growth hormone and IgA total amount of pain meds and sedatives and validated measures or surveys
Detailed Description:
Primary Objectives
To evaluate the effects of the two live and recorded prescribed preoperative and intraoperative music interventions containing CER on physiologic and perceived stress in patients undergoing awake craniotomy and
To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients in those two settings
Secondary Objectives
To measuring pre-post intervention changes in physiologic and perceived stress and mood changes including but not limited to HR HRV and MAP
To measuring changes using proteomic and metabolomic analyses in stress biomarkers and cytokines including but not limited to ACTH oxytocin dopamine norepinephrine B-endorphin growth hormone and IgA
To determine the effects of the intraoperative prescribed music intervention containing CER on agitation and sedation in awake craniotomy patients
To determine the effects of the intraoperative prescribed music intervention containing CER on sedative and analgesic requirements in awake craniotomy patients
To determine the effects of the intraoperative prescribed music interventions containing CER on time to regain consciousness in awake craniotomy patients
To evaluate the effect of the intraoperative prescribed music interventions containing CER on emergence delirium in awake craniotomy patients
To evaluate the effects of prior musical training experience preference and exposure on the above outcomes in patients
To evaluate the effects of the two live and recorded prescribed preoperative and intraoperative music interventions containing CER on physiologic and perceived stress in patients undergoing awake craniotomy and
To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients in those two settings
Secondary Objectives
To measuring pre-post intervention changes in physiologic and perceived stress and mood changes including but not limited to HR HRV and MAP
To measuring changes using proteomic and metabolomic analyses in stress biomarkers and cytokines including but not limited to ACTH oxytocin dopamine norepinephrine B-endorphin growth hormone and IgA
To determine the effects of the intraoperative prescribed music intervention containing CER on agitation and sedation in awake craniotomy patients
To determine the effects of the intraoperative prescribed music intervention containing CER on sedative and analgesic requirements in awake craniotomy patients
To determine the effects of the intraoperative prescribed music interventions containing CER on time to regain consciousness in awake craniotomy patients
To evaluate the effect of the intraoperative prescribed music interventions containing CER on emergence delirium in awake craniotomy patients
To evaluate the effects of prior musical training experience preference and exposure on the above outcomes in patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None