Music and Local Anesthesia During Dermatologic Procedures
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|ClinicalTrials.gov Identifier: NCT04317170|
Recruitment Status : Completed
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Pain Anxiety||Other: Music||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia.
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.
- 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
- 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.
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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|
- 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
- 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
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
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|Responsible Party:||Washington University School of Medicine|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|