search
Back to results

The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jazz music
No music
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring music, stress, anxiety, post-surgical, pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jazz music

No music

Arm Description

Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.

The patients in this group with have headphones but no music will be played.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Mean Blood Pressure
non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes

Full Information

First Posted
November 30, 2012
Last Updated
March 17, 2016
Sponsor
Milton S. Hershey Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01834027
Brief Title
The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
Official Title
The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
music, stress, anxiety, post-surgical, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jazz music
Arm Type
Experimental
Arm Description
Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Arm Title
No music
Arm Type
Active Comparator
Arm Description
The patients in this group with have headphones but no music will be played.
Intervention Type
Behavioral
Intervention Name(s)
Jazz music
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No music
Other Intervention Name(s)
control group
Intervention Description
In this group no music will be played in PACU
Primary Outcome Measure Information:
Title
Change in Heart Rate From Baseline on Arrival in PACU
Description
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
Secondary Outcome Measure Information:
Title
Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
Description
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
Title
Mean Difference in Patient's Perception of Pain From Baseline
Description
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
Title
Mean Blood Pressure
Description
non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes
Time Frame
60 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Vaida, MD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jansie Prozesky, MD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy

We'll reach out to this number within 24 hrs