- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834027
The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
March 17, 2016 updated by: Sonia Vaida, Milton S. Hershey Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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.
|
Active Comparator: No music
The patients in this group with have headphones but no music will be played.
|
In this group no music will be played in PACU
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Heart Rate From Baseline on Arrival in PACU
Time Frame: 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
|
5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
Time Frame: 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.
|
Once, at 30 minutes after the patient entered the PACU
|
Mean Difference in Patient's Perception of Pain From Baseline
Time Frame: 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.
|
10, 20 , and 30 minutes after baseline measurement
|
Mean Blood Pressure
Time Frame: 60 minutes
|
non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sonia Vaida, MD, Penn State University
- Principal Investigator: Jansie Prozesky, MD, Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
November 30, 2012
First Submitted That Met QC Criteria
April 16, 2013
First Posted (Estimate)
April 17, 2013
Study Record Updates
Last Update Posted (Estimate)
April 15, 2016
Last Update Submitted That Met QC Criteria
March 17, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 40925
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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