Clinical trial NCT06356324: The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery
Official title: The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Intraoperative Hypertension
Cataract
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise)
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative hypertensive event
timeFrame: From beginning of cataract surgery to the completion (approximately 15 minutes)
Secondary outcomes:
measure: Change in VAS-A measurements for Anxiety
timeFrame: From participant enrollment to after 20 minute intervention
measure: Change in Heart Rate measurements for Anxiety
timeFrame: From participant enrollment to after 20 minute intervention
measure: Change in Blood pressure measurements for Anxiety
timeFrame: From participant enrollment to after 20 minute intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Anne Barmettler, MD
role: PRINCIPAL_INVESTIGATOR
References: