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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06356324
• Other study ID #: 2021-13347
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: April 1, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cataract
• Intraoperative Hypertension

Intervention

Other:
• Music Intervention
Participants assigned to 20 minutes of music listening
• Television Intervention
Participants assigned to 20 minutes of television viewing

Locations

Country	Name	City	State
United States	Montefiore Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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