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The investigators propose to determine whether listening to classical music during a sedation procedure decreases the need for procedural sedation medication. It is a two arm study comparing music vs no music by headphones so that the investigator is blinded to the intervention. The outcome variable is amount of sedative used and self-reported anxiety level as reported on a 10 point visual analogue scale (VAS). The music intervention is begun 1 minute prior to the sedation procedure and continued until the subject is completely awake. Demographics will be collected for all patients. No identifiers are collected. Data will be compared for a change in VAS variable using non parametric methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music intervention | Experimental | Subjects will have headphones placed on 1 minute prior to procedural sedation. Classical music will be played until the subject is fully awake. |
|
| Non intervention | No Intervention | Subjects will have headphones placed on 1 minute prior to procedural sedation. No music will be played. The headphones will be removed when the subject is fully awake. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classical music | Other | Classical music will be played over the headphones |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual analogue score | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in STAI anxiety score before and after intervention | through study completion, an average of 1 year | |
| Anxiety scale- pre and post | through study completion, an average of 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Ernst, MD | UNM hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22422386 | Background | Kulkarni S, Johnson PC, Kettles S, Kasthuri RS. Music during interventional radiological procedures, effect on sedation, pain and anxiety: a randomised controlled trial. Br J Radiol. 2012 Aug;85(1016):1059-63. doi: 10.1259/bjr/71897605. Epub 2012 Mar 14. | |
| 16030507 | Background | DeLoach Walworth D. Procedural-support music therapy in the healthcare setting: a cost-effectiveness analysis. J Pediatr Nurs. 2005 Aug;20(4):276-84. doi: 10.1016/j.pedn.2005.02.016. |
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| Any positive finding on the Common Terminology Criteria for Adverse Events (CTCAEv4.0) psychiatric scale |
Number of participants with treatment related adverse events as assessed by the 20 categories in the CTCAE v4.0 psychiatric scale. |
| through study completion, an average of 1 year |
| 24731896 | Background | Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23. |
| 25139786 | Background | Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19. |
| 25878063 | Background | Yinger OS, Gooding LF. A systematic review of music-based interventions for procedural support. J Music Ther. 2015 Spring;52(1):1-77. doi: 10.1093/jmt/thv004. Epub 2015 Apr 15. |