Clinical trial NCT04317170: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Pain
Anxiety
Lidocaine
Local anesthesia
Dermatologic procedures
Dermatology
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pain: visual analog scale (VAS)
timeFrame: Assessed one time immediately after dermatologic procedure is complete
measure: Anxiety
timeFrame: Assessed one time immediately after dermatologic procedure is complete
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
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