Music Therapy in Procedural Sedation in the Emergency Department

NCT02676206 | Completed DMC

• 1 other identifier: 15-540
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Conscious Sedation Failure During Procedure

Outcome Measures

Primary Outcomes (1)

• Change in Visual analogue score

  through study completion, an average of 1 year

Secondary Outcomes (3)

• 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

• Any positive finding on the Common Terminology Criteria for Adverse Events (CTCAEv4.0) psychiatric scale

  through study completion, an average of 1 year

Study Arms (2)

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.

Other: Classical music

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.

Interventions

Classical music OTHER

Classical music will be played over the headphones

Also known as: Intervention arm

Music intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient in the UNMH ED between age 18-65
• An upper extremity (defined as distal to humerus, including humerus) or lower extremity fracture (defined as distal to femur, including femur)
• A closed fracture
• Undergoing procedural sedation for reduction of the fracture in the emergency department.

You may not qualify if:

• Clinically intoxicated
• Have dementia
• Experiencing psychosis
• Are deaf
• Patient who do not speak English
• Adults unable to consent
• Pregnant women
• Prisoners will be excluded from participation.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (5)

• 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.

  PMID: 22422386 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.

  PMID: 16030507 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.

  PMID: 24731896 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.

  PMID: 25139786 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.

  PMID: 25878063 BACKGROUND

Study Officials

• Amy Ernst, MD

  UNM hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 8, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 24, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)