Clinical trial NCT01834027: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: music
stress
anxiety
post-surgical
pain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Heart Rate From Baseline on Arrival in PACU
timeFrame: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU
Secondary outcomes:
measure: Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
timeFrame: Once, at 30 minutes after the patient entered the PACU
measure: Mean Difference in Patient's Perception of Pain From Baseline
timeFrame: 10, 20 , and 30 minutes after baseline measurement
measure: Mean Blood Pressure
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Sonia Vaida, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Jansie Prozesky, MD
role: PRINCIPAL_INVESTIGATOR
References: