Washington University in St. Louis
St Louis, Missouri, 63110, United States
NCT Number: NCT04317170
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.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
Washington University School of Medicine
Other
The Impact of a Music Intervention on Pain and Anxiety Associated With Local Anesthesia Administration During Dermatologic Procedures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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