Anxiety, Pain
Conditions
Keywords
music, stress, anxiety, post-surgical, pain
Brief summary
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.
Detailed description
* Patients will be identified the morning of surgery from the operating room schedule. * The patients will be randomized to two groups: jazz music or no music. * Head phones will be applied to all patients included in the study; in one group jazz music will be provided through the headphones. The second group no music will be played. * Blood pressure will be monitored by a non-invasive blood pressure cuff at 5 minute intervals throughout the patient's stay in the PACU. * Heart rate will be measured, using a pulse oximeter, at the same intervals as blood pressure. * Before the patient leaves the PACU, she will be asked to rate her perception of her levels of pain and anxiety on scales that use a numeric scale of 1-10. The primary variable outcomes are: heart rate and mean blood pressure. Secondary outcomes include: perceived pain, anxiety, and level of relaxation. * headphones will be used to deliver one of the following sounds to the patients: 1) jazz music (BPM\<100) by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc.; or 2) no music providing.
Interventions
BEHAVIORALJazz 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.
BEHAVIORALNo music
In this group no music will be played in PACU
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing elective hysterectomy (laparoscopic or robotic) * ASA 1 or 2 * Normotensive * Normal heart rate
Exclusion criteria
* Patient does not wish to participate in the study * Deaf or hearing impaired patients * Ear deformities or abnormalities * Pre-existing diagnosis of anxiety disorder, depression, substance abuse, or any other psychiatric diagnoses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate From Baseline on Arrival in PACU | 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU | Once, at 30 minutes after the patient entered 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. |
| Mean Difference in Patient's Perception of Pain From Baseline | 10, 20 , and 30 minutes after baseline measurement | 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. |
| Mean Blood Pressure | 60 minutes | non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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 | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Jazz Music | No Music | Total |
|---|---|---|---|
| Age, Customized >=18 and <=75 years | 28 participants | 28 participants | 56 participants |
| Age, Customized <18 years of age | 0 participants | 0 participants | 0 participants |
| Age, Customized > 75 years of age | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
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
Time frame: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jazz Music | Change in Heart Rate From Baseline on Arrival in PACU | 15 minutes after baseline measurement | -5.21 beats per minute |
| Jazz Music | Change in Heart Rate From Baseline on Arrival in PACU | 25 minutes aqfter baseline measurement | -6.68 beats per minute |
| Jazz Music | Change in Heart Rate From Baseline on Arrival in PACU | 10 minutes after baseline measurement | -4.18 beats per minute |
| Jazz Music | Change in Heart Rate From Baseline on Arrival in PACU | 30 minutes after baseline measurement | -5.71 beats per minute |
| Jazz Music | Change in Heart Rate From Baseline on Arrival in PACU | 2- minutes after baseline measurement | -6.29 beats per minute |
| Jazz Music | Change in Heart Rate From Baseline on Arrival in PACU | 5 minutes after baseline measurement | -3.39 beats per minute |
| No Music | Change in Heart Rate From Baseline on Arrival in PACU | 5 minutes after baseline measurement | -5.11 beats per minute |
| No Music | Change in Heart Rate From Baseline on Arrival in PACU | 10 minutes after baseline measurement | -4.71 beats per minute |
| No Music | Change in Heart Rate From Baseline on Arrival in PACU | 15 minutes after baseline measurement | -6.46 beats per minute |
| No Music | Change in Heart Rate From Baseline on Arrival in PACU | 2- minutes after baseline measurement | -6.61 beats per minute |
| No Music | Change in Heart Rate From Baseline on Arrival in PACU | 25 minutes aqfter baseline measurement | -8.58 beats per minute |
| No Music | Change in Heart Rate From Baseline on Arrival in PACU | 30 minutes after baseline measurement | -5.36 beats per minute |
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.
Time frame: Once, at 30 minutes after the patient entered the PACU
Population: 2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jazz Music | Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU | 0.1 units on a scale | Standard Deviation 0.92 |
| No Music | Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU | 0 units on a scale | Standard Deviation 0.43 |
Secondary
Mean Blood Pressure
non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes
Time frame: 60 minutes
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.
Time frame: 10, 20 , and 30 minutes after baseline measurement
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Jazz Music | Mean Difference in Patient's Perception of Pain From Baseline | 20 minutes after baseline measurement | 0.61 units on a scale |
| Jazz Music | Mean Difference in Patient's Perception of Pain From Baseline | 30 minutes after baseline measurement | 0.77 units on a scale |
| Jazz Music | Mean Difference in Patient's Perception of Pain From Baseline | 10 minutes after baseline measurement | 1.04 units on a scale |
| No Music | Mean Difference in Patient's Perception of Pain From Baseline | 10 minutes after baseline measurement | -0.95 units on a scale |
| No Music | Mean Difference in Patient's Perception of Pain From Baseline | 20 minutes after baseline measurement | -0.16 units on a scale |
| No Music | Mean Difference in Patient's Perception of Pain From Baseline | 30 minutes after baseline measurement | -.03 units on a scale |