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The purpose of this study is to investigate the effects of music on patients after surgery in the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant emotional stress and anxiety which can include discomfort or pain. Music therapy has proven to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has been shown that classical music can cause physiological and psychological differences in patient outcomes, but few studies have looked specifically at effects of jazz music. Some have argued that jazz may be too involved to provide the same relaxed state as classical music, but this may be due in part to the type of jazz played for the patient. It is our hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the control group. Jazz music or "no music" will be played through headphones to participants in the study post-surgically while they are in the PACU and measures of stress, anxiety, and pain will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jazz music | Experimental | Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit. |
|
| No music | Active Comparator | The patients in this group with have headphones but no music will be played. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jazz music | Behavioral | Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate From Baseline on Arrival in PACU | Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry | 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU | Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Vaida, MD | Penn State University | Principal Investigator |
| Jansie Prozesky, MD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Jazz Music | Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit. Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit. |
| FG001 | No Music | The patients in this group with have headphones but no music will be played. No music: In this group nu music will be played in PACU |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The statistical plan and sample size justification were based on the results of a previous study (Nilsson, U. Heart Lung 2009;38(3):201-207) comparing the change in heart rate from pre- to post-surgery between a music and control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Jazz Music | Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit. Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change in Heart Rate From Baseline on Arrival in PACU | Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry | Posted | Mean | 95% Confidence Interval | beats per minute | 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU |
|
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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 | Jazz Music | Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit. Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonia Vaida | Penn State Milton S. Hershey Medical Center | 7175318433 | svaida@hmc.psu.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| No music | Behavioral | In this group no music will be played in PACU |
|
|
| Once, at 30 minutes after the patient entered the PACU |
| Mean Difference in Patient's Perception of Pain From Baseline | The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated. | 10, 20 , and 30 minutes after baseline measurement |
| Mean Blood Pressure | non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes | 60 minutes |
| BG001 | No Music | The patients in this group will have noise-cancelling headphones but no music will be played. No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The patients in this group with have headphones but no music will be played. No music: In this group nu music will be played in PACU |
|
|
| Secondary | Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU | Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated. | 2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score. | Posted | Mean | Standard Deviation | units on a scale | Once, at 30 minutes after the patient entered the PACU |
|
|
|
| Secondary | Mean Difference in Patient's Perception of Pain From Baseline | The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated. | Posted | Mean | 95% Confidence Interval | units on a scale | 10, 20 , and 30 minutes after baseline measurement |
|
|
|
| Secondary | Mean Blood Pressure | non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes | Not Posted | 60 minutes |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | No Music | The patients in this group with have headphones but no music will be played. No music: In this group nu music will be played in PACU | 0 | 28 | 0 | 28 |
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| D008722 | Methods |
| 30 minutes after baseline measurement |
|