NCT01409044

Effect of Music on Pain and Anxiety After Surgery

Terminated Phase 3 Last updated 10 August 2017

What this trial tests

Phase 3 trial testing Music in Postop Adult ICU Patients in 62 participants. Terminated before completion.

Timeline

17 June 2011

Primary endpoint
9 May 2013

8 August 2017

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	62
Start date	17 June 2011
Primary completion	9 May 2013
Estimated completion	8 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Music

Conditions studied

• Postop Adult ICU Patients — all drugs for Postop Adult ICU Patients →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 99, any sex, with Postop Adult ICU Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Music Listening Among Postoperative Patients in the Intensive Care Unit: A Randomized Controlled Trial with Mixed-Methods Analysis.
   Ames N, Shuford R, Yang L, Moriyama B, et al · · 2017 · cited 21× · PMID 28904523 · DOI 10.1177/1178633717716455