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Music and Local Anesthesia During Dermatologic Procedures

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring Pain, Anxiety, Lidocaine, Local anesthesia, Dermatologic procedures, Dermatology

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects undergoing dermatologic procedures on the head and neck
  • Ages 18-89 years old
  • English speaking
  • Willingness and the ability to understand and provide informed consent

Exclusion Criteria:

  • Subjects who are allergic to lidocaine
  • History of bleeding tendency or coagulopathy
  • Pregnant or lactating
  • Active skin infection in the treatment area
  • Active cancer diagnosis
  • Unable to understand the protocol or give informed consent
  • Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music

No Music

Arm Description

Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia.

Patients will undergo their routine procedure without being played music.

Outcomes

Primary Outcome Measures

Pain: visual analog scale (VAS)
Subjects will rate the pain using the visual analog scale (VAS), which is a 10 cm line ranging from "no pain" (far left) to "extremely painful" (far right) where patients mark their pain score with a vertical line
Anxiety
Subjects will rate their anxiety using the short form of the state trait anxiety inventory (STAI), which asks participants 6 questions about their anxiety levels and asks them to rank their response from 1-4.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2020
Last Updated
March 20, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04317170
Brief Title
Music and Local Anesthesia During Dermatologic Procedures
Official Title
The Impact of a Music Intervention on Pain and Anxiety Associated With Local Anesthesia Administration During Dermatologic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of the study is to determine the effect of classical music on participants pain and anxiety associated with lidocaine administration during routine standard of care dermatologic procedures.
Detailed Description
The study is a randomized, unblinded, prospective, single center clinical trial. The purpose of the study is to determine the effect of a music intervention in reducing anxiety and pain from local anesthesia administration in subjects undergoing a routine, standard of care dermatologic procedure. The study population will consist of 100 adult subjects undergoing a dermatologic procedure on the head and neck. Subjects will be randomized 1:1 into either the placebo or music intervention group. Individuals randomized into the placebo (P) group will undergo a set of standardized steps prior to local anesthesia injection. Other factors such as skin preparation technique, needle size, anesthesia temperature, use of unbuffered solution, needle angle and approximate depth of injection will remain standardized. Individuals randomized into the music intervention (MI) group will undergo the same set of standardized steps and then be played Frederic Chopin's piano sonatas through a headphone device prior to injection. After local anesthesia administration, subjects in both treatment arms will be asked to fill out a demographics, pain and anxiety questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Pain, Anxiety, Lidocaine, Local anesthesia, Dermatologic procedures, Dermatology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia.
Arm Title
No Music
Arm Type
No Intervention
Arm Description
Patients will undergo their routine procedure without being played music.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia during their routine standard of care dermatologic procedure
Primary Outcome Measure Information:
Title
Pain: visual analog scale (VAS)
Description
Subjects will rate the pain using the visual analog scale (VAS), which is a 10 cm line ranging from "no pain" (far left) to "extremely painful" (far right) where patients mark their pain score with a vertical line
Time Frame
Assessed one time immediately after dermatologic procedure is complete
Title
Anxiety
Description
Subjects will rate their anxiety using the short form of the state trait anxiety inventory (STAI), which asks participants 6 questions about their anxiety levels and asks them to rank their response from 1-4.
Time Frame
Assessed one time immediately after dermatologic procedure is complete

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects undergoing dermatologic procedures on the head and neck Ages 18-89 years old English speaking Willingness and the ability to understand and provide informed consent Exclusion Criteria: Subjects who are allergic to lidocaine History of bleeding tendency or coagulopathy Pregnant or lactating Active skin infection in the treatment area Active cancer diagnosis Unable to understand the protocol or give informed consent Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23985640
Citation
Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2.
Results Reference
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PubMed Identifier
23346989
Citation
Vachiramon V, Sobanko JF, Rattanaumpawan P, Miller CJ. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. Dermatol Surg. 2013 Feb;39(2):298-305. doi: 10.1111/dsu.12047. Epub 2013 Jan 24.
Results Reference
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PubMed Identifier
22617633
Citation
Taddio A, Ipp M, Thivakaran S, Jamal A, Parikh C, Smart S, Sovran J, Stephens D, Katz J. Survey of the prevalence of immunization non-compliance due to needle fears in children and adults. Vaccine. 2012 Jul 6;30(32):4807-12. doi: 10.1016/j.vaccine.2012.05.011. Epub 2012 May 19.
Results Reference
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PubMed Identifier
26352921
Citation
Boerner KE, Birnie KA, Chambers CT, Taddio A, McMurtry CM, Noel M, Shah V, Pillai Riddell R; HELPinKids&Adults Team. Simple Psychological Interventions for Reducing Pain From Common Needle Procedures in Adults: Systematic Review of Randomized and Quasi-Randomized Controlled Trials. Clin J Pain. 2015 Oct;31(10 Suppl):S90-8. doi: 10.1097/AJP.0000000000000270.
Results Reference
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PubMed Identifier
26951939
Citation
Kouba DJ, LoPiccolo MC, Alam M, Bordeaux JS, Cohen B, Hanke CW, Jellinek N, Maibach HI, Tanner JW, Vashi N, Gross KG, Adamson T, Begolka WS, Moyano JV. Guidelines for the use of local anesthesia in office-based dermatologic surgery. J Am Acad Dermatol. 2016 Jun;74(6):1201-19. doi: 10.1016/j.jaad.2016.01.022. Epub 2016 Mar 4.
Results Reference
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PubMed Identifier
11458859
Citation
Huron D. Is music an evolutionary adaptation? Ann N Y Acad Sci. 2001 Jun;930:43-61. doi: 10.1111/j.1749-6632.2001.tb05724.x.
Results Reference
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PubMed Identifier
18395022
Citation
Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
Results Reference
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PubMed Identifier
22506884
Citation
Chen X, Seth RK, Rao VS, Huang JJ, Adelman RA. Effects of music therapy on intravitreal injections: a randomized clinical trial. J Ocul Pharmacol Ther. 2012 Aug;28(4):414-9. doi: 10.1089/jop.2011.0257. Epub 2012 Apr 16.
Results Reference
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PubMed Identifier
10076111
Citation
Jacobson AF. Intradermal normal saline solution, self-selected music, and insertion difficulty effects on intravenous insertion pain. Heart Lung. 1999 Mar-Apr;28(2):114-22. doi: 10.1053/hl.1999.v28.a95256.
Results Reference
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Music and Local Anesthesia During Dermatologic Procedures

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