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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music | Experimental | Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia. |
|
| No Music | No Intervention | Patients will undergo their routine procedure without being played music. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23985640 | Background | Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2. | |
| 23346989 | Background | Vachiramon V, Sobanko JF, Rattanaumpawan P, Miller CJ. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. Dermatol Surg. 2013 Feb;39(2):298-305. doi: 10.1111/dsu.12047. Epub 2013 Jan 24. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 22617633 | Background | Taddio A, Ipp M, Thivakaran S, Jamal A, Parikh C, Smart S, Sovran J, Stephens D, Katz J. Survey of the prevalence of immunization non-compliance due to needle fears in children and adults. Vaccine. 2012 Jul 6;30(32):4807-12. doi: 10.1016/j.vaccine.2012.05.011. Epub 2012 May 19. |
| 26352921 | Background | Boerner KE, Birnie KA, Chambers CT, Taddio A, McMurtry CM, Noel M, Shah V, Pillai Riddell R; HELPinKids&Adults Team. Simple Psychological Interventions for Reducing Pain From Common Needle Procedures in Adults: Systematic Review of Randomized and Quasi-Randomized Controlled Trials. Clin J Pain. 2015 Oct;31(10 Suppl):S90-8. doi: 10.1097/AJP.0000000000000270. |
| 26951939 | Background | Kouba DJ, LoPiccolo MC, Alam M, Bordeaux JS, Cohen B, Hanke CW, Jellinek N, Maibach HI, Tanner JW, Vashi N, Gross KG, Adamson T, Begolka WS, Moyano JV. Guidelines for the use of local anesthesia in office-based dermatologic surgery. J Am Acad Dermatol. 2016 Jun;74(6):1201-19. doi: 10.1016/j.jaad.2016.01.022. Epub 2016 Mar 4. |
| 11458859 | Background | Huron D. Is music an evolutionary adaptation? Ann N Y Acad Sci. 2001 Jun;930:43-61. doi: 10.1111/j.1749-6632.2001.tb05724.x. |
| 18395022 | Background | Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013. |
| 22506884 | Background | Chen X, Seth RK, Rao VS, Huang JJ, Adelman RA. Effects of music therapy on intravitreal injections: a randomized clinical trial. J Ocul Pharmacol Ther. 2012 Aug;28(4):414-9. doi: 10.1089/jop.2011.0257. Epub 2012 Apr 16. |
| 10076111 | Background | Jacobson AF. Intradermal normal saline solution, self-selected music, and insertion difficulty effects on intravenous insertion pain. Heart Lung. 1999 Mar-Apr;28(2):114-22. doi: 10.1053/hl.1999.v28.a95256. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |