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Effect of Music on Pain and Anxiety After Surgery

NCT01409044 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Postop Adult ICU Patients

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Nancy Ames, R.N. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-17
Primary Completion
2013-05-09
Completion
2017-08-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409044 on ClinicalTrials.gov