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Completed

NCT Number: NCT06356324

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

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?

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Key information

Conditions

Anxiety Anxiety Disorders Cataract Eye Diseases Intraoperative Hypertension Lens Diseases Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention

Other

Participants assigned to 20 minutes of music listening

Television Intervention

Other

Participants assigned to 20 minutes of television viewing

Primary outcomes

  1. Intraoperative hypertensive event

    Time frame: From beginning of cataract surgery to the completion (approximately 15 minutes)

    The primary outcome of this study is the occurrence of one hypertensive event (defined as BP >160/>100) during the procedure (cataract surgery).

Secondary outcomes

  1. Change in VAS-A measurements for Anxiety

    Time frame: From participant enrollment to after 20 minute intervention

    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.

  2. Change in Heart Rate measurements for Anxiety

    Time frame: From participant enrollment to after 20 minute intervention

    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.

  3. Change in Blood pressure measurements for Anxiety

    Time frame: From participant enrollment to after 20 minute intervention

    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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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