AnxietyNCT06356324
The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery
A study testing Music Intervention and Television Intervention in people with Anxiety and Intraoperative Hypertension, run by Montefiore Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Intraoperative Hypertension, Cataract
- What is being tested?
- Music Intervention and Television Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants undergoing cataract surgery at Montefiore Medical Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery: A Randomized Clinical Trial
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:
- Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
- Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
Read the 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.
- Conditions
- Anxiety, Intraoperative Hypertension, Cataract
- Being tested
- Music Intervention, Television Intervention
- Medical subject headings
- Anxiety Disorders, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music InterventionOther
Participants assigned to 20 minutes of music listening
Television InterventionOther
Participants assigned to 20 minutes of television viewing
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | Participants instructed to listen to 20 minutes of relaxing classical music (e.g., Chopin, Mozart) Receives: Other: Music Intervention |
| Television intervention | Experimental | Participants instructed to watch a 20 minute segment of a relaxing home improvement show (e.g., House Hunters) Receives: Other: Television Intervention |
| Control | No intervention | Participants instructed to wait in their preoperative room with no added stimulus intervention (i.e., music or television) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From beginning of cataract surgery to the completion (approximately 15 minutes)
Secondary outcomes (3)
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.
Measured: From participant enrollment to after 20 minute intervention
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.
Measured: From participant enrollment to after 20 minute intervention
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.
Measured: From participant enrollment to after 20 minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start18 Oct 2021
- Primary completion31 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Barmettler, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356324
- Sponsor's protocol ID
- 2021-13347
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng T, Paramo R, Curley M, Kodali S, Zong A, Barmettler A. Television decreases intra-operative hypertensive events in cataract surgery: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2026 Jun;264(6):1671-1678. doi: 10.1007/s00417-026-07140-4. Epub 2026 Feb 25.
PubMed 41739180
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06356324
- Acronym / sponsor ID
- 2021-13347
- Conditions
- Anxiety, Intraoperative Hypertension, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise)
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Other: Music InterventionParticipants instructed to listen to 20 minutes of relaxing classical music (e.g., Chopin, Mozart) |
| Television intervention | Experimental | Other: Television InterventionParticipants instructed to watch a 20 minute segment of a relaxing home improvement show (e.g., House Hunters) |
| Control | No intervention | –Participants instructed to wait in their preoperative room with no added stimulus intervention (i.e., music or television) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants undergoing cataract surgery at Montefiore Medical Center
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music InterventionParticipants assigned to 20 minutes of music listening | Other | Music intervention |
| Television InterventionParticipants assigned to 20 minutes of television viewing | Other | Television intervention |
Primary outcome
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).
3 secondary outcomes
Change in VAS-A measurements for Anxiety
Time frame: From participant enrollment to after 20 minute intervention
Change in Heart Rate measurements for Anxiety
Time frame: From participant enrollment to after 20 minute intervention
Change in Blood pressure measurements for Anxiety
Time frame: From participant enrollment to after 20 minute intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 41739180Cheng T, Paramo R, Curley M, Kodali S, Zong A, Barmettler A. Television decreases intra-operative hypertensive events in cataract surgery: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2026 Jun;264(6):1671-1678. doi: 10.1007/s00417-026-07140-4. Epub 2026 Feb 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Barmettler, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention and Television Intervention in people with Anxiety and Intraoperative Hypertension, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative hypertensive event (time frame: From beginning of cataract surgery to the completion (approximately 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06356324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.