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This is a clinical study that aims to determine the effective dose of music listening duration that is required to reduce anxiety in patients awaiting scheduled cesarean section. It will also compare types of music to accomplish this goal, both of which have been shown effective in prior studies. Methods will involve enrolling and playing music for patients awaiting scheduled C-section, and scoring their anxiety with pre- and post-music questionnaires. Music duration for each subject will be predetermined, and analysis of response will be performed to determine the effective dose 95%, or dose at which 95% of subjects should have a positive response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mozart | Active Comparator | Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety. |
|
| Patient preference | Active Comparator | Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mozart selections | Other | Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Score | Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome. | 4-8 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| STAI | 6-question abbreviated state-trait anxiety inventory (STAI) questions asked and scored on a 6-24 point scale (higher is more anxiety) for before and after intervention. Decrease in score after intervention was considered a positive response, with larger decreases indicating better responses. | 4-8 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Drzymalski, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mozart | Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety. |
| FG001 | Patient Preference | Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of individuals grouped by intervention received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mozart | Subjects in this arm listened to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety. |
| BG001 | Patient Preference |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anxiety Score | Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 4-8 minutes |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mozart | Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety. Mozart selections: Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety. |
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Minimum required number of participants recruited was achieved. Larger sample sizes may have yielded results of stronger statistical significance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Drzymalski, MD | Tufts Medical Center | 617-913-8168 | dan.drzymalski@tuftsmedicine.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2023 | Feb 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Patient-preferred music selections | Other | Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice. |
|
Subjects in this arm listened to music from a list of pre-selected pieces of their own choosing.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gestational age | Mean | Standard Deviation | Weeks |
|
| Gravidity | Mean | Standard Deviation | Pregnancies |
|
| Parity | Mean | Standard Deviation | Births |
|
|
|
| Secondary | STAI | 6-question abbreviated state-trait anxiety inventory (STAI) questions asked and scored on a 6-24 point scale (higher is more anxiety) for before and after intervention. Decrease in score after intervention was considered a positive response, with larger decreases indicating better responses. | Posted | Mean | Standard Deviation | score on a scale | 4-8 minutes |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Patient Preference | Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing. Patient-preferred music selections: Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice. | 0 | 20 | 0 | 20 | 0 | 20 |
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