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

NCT06356324 | Completed

• 1 other identifier: 2021-13347
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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. 1.Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
2. 2.Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?

Conditions

Anxiety; Intraoperative Hypertension; Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in VAS-A measurements for Anxiety

  From participant enrollment to after 20 minute intervention

• Change in Heart Rate measurements for Anxiety

  From participant enrollment to after 20 minute intervention

• Change in Blood pressure measurements for Anxiety

  From participant enrollment to after 20 minute intervention

Study Arms (3)

Music intervention

EXPERIMENTAL

Participants instructed to listen to 20 minutes of relaxing classical music (e.g., Chopin, Mozart)

Other: Music Intervention

Television intervention

EXPERIMENTAL

Participants instructed to watch a 20 minute segment of a relaxing home improvement show (e.g., House Hunters)

Other: Television Intervention

Control

NO INTERVENTION

Participants instructed to wait in their preoperative room with no added stimulus intervention (i.e., music or television)

Interventions

Music Intervention OTHER

Participants assigned to 20 minutes of music listening

Music intervention

Television Intervention OTHER

Participants assigned to 20 minutes of television viewing

Television intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants undergoing cataract surgery at Montefiore Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

New York, New York, 10467, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Cataract

Condition Hierarchy (Ancestors)

Mental Disorders; Lens Diseases; Eye Diseases

Study Officials

• Anne Barmettler, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise)

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: October 18, 2021
• Primary Completion: January 31, 2024
• Study Completion: April 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)