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

• ClinicalTrials.gov Identifier: NCT01834027
• Recruitment Status: Completed
• First Posted: April 17, 2013
• Results First Posted: August 22, 2014
• Last Update Posted: April 15, 2016
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Sonia Vaida, Penn State University

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.

Condition or disease	Intervention/treatment	Phase
Pain; Anxiety	Behavioral: Jazz music; Behavioral: No music	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
• Study Start Date: March 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

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.	Behavioral: 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.
Active Comparator: No music; The patients in this group with have headphones but no music will be played.	Behavioral: No music; In this group no music will be played in PACU; Other Name: control group

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. Mean Blood Pressure [ Time Frame: 60 minutes ]
   non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Sonia Vaida, MD; Penn State University
• Principal Investigator: Jansie Prozesky, MD; Penn State University

More Information

• Responsible Party: Sonia Vaida, Professor of Anesthesiology, Penn State University
• ClinicalTrials.gov Identifier: NCT01834027
• Other Study ID Numbers: IRB 40925
• First Posted: April 17, 2013
• Results First Posted: August 22, 2014
• Last Update Posted: April 15, 2016
• Last Verified: March 2016

Keywords provided by Sonia Vaida, Penn State University:

music; stress; anxiety; post-surgical; pain

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations