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Music and Local Anesthesia During Dermatologic Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04317170
Recruitment Status : Completed
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Anxiety Other: Music Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impact of a Music Intervention on Pain and Anxiety Associated With Local Anesthesia Administration During Dermatologic Procedures
Actual Study Start Date : March 21, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Music
Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia.
 Other: Music
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
No Intervention: No Music
Patients will undergo their routine procedure without being played music.


Outcome Measures
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Primary Outcome Measures :
  1. Pain: visual analog scale (VAS) [ Time Frame: Assessed one time immediately after dermatologic procedure is complete ]
    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

  2. Anxiety [ Time Frame: Assessed one time immediately after dermatologic procedure is complete ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317170


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
More Information
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Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04317170    
Other Study ID Numbers: 201812098
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Pain
Anxiety
Lidocaine
 Local anesthesia
Dermatologic procedures
Dermatology
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders