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NCT01409044 · ClinicalTrials.gov registry record · Phase 3
Effect of Music on Pain and Anxiety After Surgery
A Phase 3 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT01409044 is a Phase 3 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 62 participants.
The verdict
NCT01409044, a Phase 3 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
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.
Interventions
- OTHER Music
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2011-06-17 |
| Est. Completion | 2017-08-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01409044
The ClinicalTrials.gov registry entry for NCT01409044 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Music is the first listed.
NCT01409044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01409044 about?
NCT01409044 is a clinical study titled "Effect of Music on Pain and Anxiety After Surgery". 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 musi...
What is the current status of trial NCT01409044?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2011-06-17. Estimated completion is 2017-08-08.
What interventions are being tested in trial NCT01409044?
The interventions under investigation include: Music (OTHER).
Who is sponsoring clinical trial NCT01409044?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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