The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery
NCT ID: NCT06356324
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
650 participants
INTERVENTIONAL
2021-10-18
2024-04-01
Brief Summary
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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?
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Music intervention
Participants instructed to listen to 20 minutes of relaxing classical music (e.g., Chopin, Mozart)
Music Intervention
Participants assigned to 20 minutes of music listening
Television intervention
Participants instructed to watch a 20 minute segment of a relaxing home improvement show (e.g., House Hunters)
Television Intervention
Participants assigned to 20 minutes of television viewing
Control
Participants instructed to wait in their preoperative room with no added stimulus intervention (i.e., music or television)
No interventions assigned to this group
Interventions
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Music Intervention
Participants assigned to 20 minutes of music listening
Television Intervention
Participants assigned to 20 minutes of television viewing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anne Barmettler, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
New York, New York, United States
Countries
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Other Identifiers
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2021-13347
Identifier Type: -
Identifier Source: org_study_id
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