Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356324
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Brief Title:
The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events
The key questions that are to be answered are
1 Does watching television before cataract surgery decrease intraoperative hypertensive events andor pre-operative anxiety in patients
2 Does listening to music before cataract surgery decrease intraoperative hypertensive events andor pre-operative anxiety in patients
The key questions that are to be answered are
1 Does watching television before cataract surgery decrease intraoperative hypertensive events andor pre-operative anxiety in patients
2 Does listening to music before cataract surgery decrease intraoperative hypertensive events andor pre-operative anxiety in patients
Detailed Description:
The study addresses the gap in literature regarding TV viewings efficacy in ophthalmic surgery anxiety reduction It aims to provide insights into cost-effective methods for stress reduction and surgical optimization Through voluntary participation and rigorous methodology it seeks to enhance patient experience and outcomes in ophthalmic surgery
Study Design Randomized controlled design with three groups control television intervention or music intervention
Objective Investigate effects of TV viewing and music listening on pre-operative anxiety in ophthalmic surgery
Comparison Compare relaxation effects of TV and music
Participants Aim to recruit 200 per intervention arm from Montefiore Medical Center
Baseline Assessment Measure anxiety levels pre-intervention
Interventions Administer TV or music for 20 minutes pre-surgery
Assessment Evaluate anxiety levels and physiological markers pre- and post-intervention
Monitoring Monitor vital signs during surgery and post-operative period
Data Collection Document demographic info medical history and baseline anxiety
Measurement Tools Use Visual Analog Scale VAS for subjective assessment and physiological markers
Analysis Compare outcomes across intervention arms using statistical tests
Study Design Randomized controlled design with three groups control television intervention or music intervention
Objective Investigate effects of TV viewing and music listening on pre-operative anxiety in ophthalmic surgery
Comparison Compare relaxation effects of TV and music
Participants Aim to recruit 200 per intervention arm from Montefiore Medical Center
Baseline Assessment Measure anxiety levels pre-intervention
Interventions Administer TV or music for 20 minutes pre-surgery
Assessment Evaluate anxiety levels and physiological markers pre- and post-intervention
Monitoring Monitor vital signs during surgery and post-operative period
Data Collection Document demographic info medical history and baseline anxiety
Measurement Tools Use Visual Analog Scale VAS for subjective assessment and physiological markers
Analysis Compare outcomes across intervention arms using statistical tests
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