NCT06356324

The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery

The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 and/or pre-operative anxiety in patients? 2. Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?

Detailed description

The study addresses the gap in literature regarding TV viewing's 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.

Conditions

• Anxiety
• Intraoperative Hypertension
• Cataract

Interventions

Type	Name	Description
OTHER	Music Intervention	Participants assigned to 20 minutes of music listening
OTHER	Television Intervention	Participants assigned to 20 minutes of television viewing

Timeline

• Start date: 2021-10-18
• Primary completion: 2024-01-31
• Completion: 2024-04-01
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: United States