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

NCT01834027 | Completed Results

• 1 other identifier: IRB 40925
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

music; stress; anxiety; post-surgical; pain

Outcome Measures

Primary Outcomes (1)

• 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

  5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU

Secondary Outcomes (3)

• 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

• Mean Difference in Patient's Perception of Pain From Baseline

  10, 20 , and 30 minutes after baseline measurement

• Mean Blood Pressure

  60 minutes

Study Arms (2)

Jazz music

EXPERIMENTAL

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

Behavioral: Jazz music

No music

ACTIVE COMPARATOR

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

Behavioral: No music

Interventions

Jazz music BEHAVIORAL

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.

Jazz music

No music BEHAVIORAL

In this group no music will be played in PACU

Also known as: control group

No music

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective hysterectomy (laparoscopic or robotic)
• ASA 1 or 2
• Normotensive
• Normal heart rate

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Sonia Vaida
• Organization: Penn State Milton S. Hershey Medical Center

svaida@hmc.psu.edu

7175318433

Study Officials

• Sonia Vaida, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Jansie Prozesky, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: April 17, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 15, 2016
• Results First Posted: August 22, 2014

Record last verified: 2016-03

Locations

US (1)