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

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?

Study Overview

• Status: Completed
• Conditions: Anxiety; Cataract; Intraoperative Hypertension
• Intervention / Treatment: Other: Music Intervention; Other: Television Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music intervention; Participants instructed to listen to 20 minutes of relaxing classical music (e.g., Chopin, Mozart)	Other: Music Intervention; Participants assigned to 20 minutes of music listening
Experimental: Television intervention; Participants instructed to watch a 20 minute segment of a relaxing home improvement show (e.g., House Hunters)	Other: Television Intervention; Participants assigned to 20 minutes of television viewing
No Intervention: Control; Participants instructed to wait in their preoperative room with no added stimulus intervention (i.e., music or television)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative hypertensive event	The primary outcome of this study is the occurrence of one hypertensive event (defined as BP >160/>100) during the procedure (cataract surgery).	From beginning of cataract surgery to the completion (approximately 15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS-A measurements for Anxiety	The Visual Analog Scale for Anxiety (VAS-A) will be used to assess anxiety. The VAS-A is a validated tool for evaluating preoperative anxiety. Visual anxiety analog scale is used to score patient's anxiety levels. The scale ranges from 0 to 10, where 0 represents not anxious and 10 represents extreme anxiety. Participants have baseline measurements of VAS-A scores before 20 minute intervention, and after 20 minute intervention.	From participant enrollment to after 20 minute intervention
Change in Heart Rate measurements for Anxiety	A physiological marker of anxiety is increased heart rate. As such, participants' heart rates will be measured (as heart beats per minute, bpm) and included in the data analysis. Participants have baseline measurements of heart rate before 20 minute intervention, and after 20 minute intervention.	From participant enrollment to after 20 minute intervention
Change in Blood pressure measurements for Anxiety	A physiological marker of anxiety is increased blood pressure. As such, participants' blood pressures will be measured (systolic and diastolic pressure in mmHg) and included in the data analysis. Participants have baseline measurements of blood pressure before 20 minute intervention, and after 20 minute intervention.	From participant enrollment to after 20 minute intervention

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Anne Barmettler, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2021-13347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No