Effect of Music on Pain and Anxiety After Surgery

August 9, 2017 updated by: National Institutes of Health Clinical Center (CC)

The Effect of Music Listening on the Amount of Opioids Used in Surgical Intensive Care Patients

Background:

- Studies have shown that listening to music can decrease pain and anxiety. Following surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If listening to music can help lower pain and anxiety levels, less medication might be needed and these side effects could be avoided.

Objectives:

- To determine the effects of music on patient pain and anxiety in the first few days after surgery.

Eligibility:

- Individuals at least 18 years of age who are scheduled to have surgery that requires a 24-48-hour stay in intensive care afterward.

Design:

  • All participants will be screened with a medical history before having surgery.
  • Participants will be divided into two groups: one group will listen to music after surgery, and the other will not.
  • Before surgery, participants will answer questions about their pain and anxiety levels. They will also be shown how to control the device that lets them administer their own pain medication after surgery.
  • Following surgery, all participants will be transferred to the ICU and will answer the same questions about pain and anxiety levels.
  • The music group will listen to a specially created CD of instrumental music for about 50 minutes, four times a day. The standard group will not listen to this music. All other treatments will be the same in both groups. Both groups will continue to answer the same questions about pain and anxiety levels.
  • Participants will have a final 15- to 20-minute interview after leaving the ICU. They will answer questions about the ICU stay and (for those in the music listening group) the music.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Background:

  • Listening to music is a common human activity. Music listening has been associated with decreased pain scores, increase in attentiveness and decrease in anxiety scores. Recently, with interest in holistic and complementary and alternative therapies, there has been increased awareness of the potential positive health effects of music listening.
  • Inadequate pain management remains common especially in postoperative patients. Acute perioperative pain affects over 46 million Americans every year.
  • As music is processed by the limbic system, enkephalins and endorphins are released. These substances are natural occurring opioids, suggesting music may decrease patient s requirements for opioids.

Primary Objective:

To determine the effects of music listening on the amount of opioids delivered postoperatively to adult ICU patients via patient-controlled analgesia (PCA) during the first 48 hours.

Secondary Objective:

To determine the effects of music listening on pain and anxiety scores experienced by adult surgical patients during the first 48 hours postoperatively in the ICU.

Eligibility:

-All adult patients (18 years of age or greater) who are scheduled for surgery that have an anticipated ICU stay of 24-48 hours.

Design:

The design is a two-group randomized controlled trial. The two groups are:

  • Treatment -Music group - intervention music delivered for approximately 50 minutes 4 times a day
  • Control - Standard care

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

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

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Adult surgical patients hospitalized in the NIH, Clinical Center (CC) who have an anticipated ICU stay of 24-48 hours postoperatively and the planned postoperative pain management schema includes opioids delivered via intravenous or epidural PCA device.
  • General surgery, urology and thoracic surgery patients
  • Oriented to person, time and place
  • Age greater than or equal to 18 years
  • Understands and speaks English or Spanish

EXCLUSION CRITERIA:

  • Scheduled for a neurosurgical procedure
  • Hearing or visually Impaired
  • Diagnosed with General Anxiety Disorder (GAD) or patients who score greater than or equal to 15 on the GAD-7 screening instrument.
  • Speaks language other than Spanish or English
  • Intubated for greater than 4 hours post-operatively

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music
Research participant listened to music
Other: Music
Music listening for the treatment group. Music is from MusicCure selection "Dreams". Outocmes are compared to control group who receives no music. Subjects are randomized Post-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Opiate use
Time Frame: 48 hours in the ICU
48 hours in the ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain, anxiety and distress outcome measures
Time Frame: 48 hours in the ICU
48 hours in the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 17, 2011

Primary Completion (Actual)

May 9, 2013

Study Completion (Actual)

August 8, 2017

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 8, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 110201
  • 11-CC-0201

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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