Anxiety Clinical Trial
Official title:
The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery: A Randomized Clinical Trial
Verified date | April 2024 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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 |
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