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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01409044 |
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Date of registration:
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02/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Music on Pain and Anxiety After Surgery
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Scientific title:
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The Effect of Music Listening on the Amount of Opioids Used in Surgical Intensive Care Patients |
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Date of first enrolment:
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June 17, 2011 |
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Target sample size:
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62 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01409044 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Nancy Ames, R.N. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institutes of Health Clinical Center (CC) |
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Key inclusion & exclusion criteria
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- 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
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postop Adult ICU Patients
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Intervention(s)
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Other: Music
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Primary Outcome(s)
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Opiate use
[Time Frame: 48 hours in the ICU]
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Secondary Outcome(s)
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Pain, anxiety and distress outcome measures
[Time Frame: 48 hours in the ICU]
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Secondary ID(s)
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11-CC-0201
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110201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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