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Effect of Music on Pain and Anxiety After Surgery

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409044
First Posted: August 3, 2011
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
August 2, 2011
August 3, 2011
August 10, 2017
June 17, 2011
May 9, 2013   (Final data collection date for primary outcome measure)
Opiate use [ Time Frame: 48 hours in the ICU ]
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.
Complete list of historical versions of study NCT01409044 on ClinicalTrials.gov Archive Site
Pain, anxiety and distress outcome measures [ Time Frame: 48 hours in the ICU ]
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.
Not Provided
Not Provided
 
Effect of Music on Pain and Anxiety After Surgery
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.

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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Postop Adult ICU Patients
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.
Experimental: Music
Research participant listened to music
Intervention: Other: Music

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
62
August 8, 2017
May 9, 2013   (Final data collection date for primary outcome measure)
  • 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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01409044
110201
11-CC-0201
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
Not Provided
Principal Investigator: Nancy Ames, R.N. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
August 8, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP