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

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Intraoperative Hypertension; Cataract; Anxiety

Treatments: Other: Music Intervention; Other: Television Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06356324

2021-13347

Details and patient eligibility

About

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?

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants undergoing cataract surgery at Montefiore Medical Center

Exclusion criteria

• Participants with severe hearing loss or speech impairment
• Participants with vision loss greater than count fingers
• Participants with uncontrolled hypertension (defined as >160/>100 despite use of antihypertensive medication)
• Participants who do not have the capacity to provide consent or who require a surrogate to provide consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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650 participants in 3 patient groups

Music intervention

Experimental group

Description:

Participants instructed to listen to 20 minutes of relaxing classical music (e.g., Chopin, Mozart)

Treatment:

Other: Music Intervention

Television intervention

Experimental group

Description:

Participants instructed to watch a 20 minute segment of a relaxing home improvement show (e.g., House Hunters)

Treatment:

Other: Television Intervention

Control

No Intervention group

Description:

Participants instructed to wait in their preoperative room with no added stimulus intervention (i.e., music or television)