Music and Local Anesthesia During Dermatologic Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of a Music Intervention on Pain and Anxiety Associated With Local Anesthesia Administration During Dermatologic Procedures

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia. | Other: Music<br>* 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<br>|
| No Intervention: No Music<br>Patients will undergo their routine procedure without being played music. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessed one time immediately after dermatologic procedure is complete | 
| 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. | Assessed one time immediately after dermatologic procedure is complete | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Anxiety, Lidocaine, Local anesthesia, Dermatologic procedures, Dermatology