Anxiety, Pain
Conditions
Keywords
Pain, Anxiety, Lidocaine, Local anesthesia, Dermatologic procedures, Dermatology
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.
Interventions
OTHERMusic
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
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain: visual analog scale (VAS) | 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 |
| Anxiety | 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. |
Countries
United States
Outcome results
None listed