Music and Local Anesthesia During Dermatologic Procedures

NCT04317170 | Completed DMC

• 1 other identifier: 201812098
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Pain; Anxiety; Lidocaine; Local anesthesia; Dermatologic procedures; Dermatology

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Music

EXPERIMENTAL

Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia.

Other: Music

No Music

NO INTERVENTION

Patients will undergo their routine procedure without being played music.

Interventions

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

Music

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (9)

• 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.

  PMID: 23985640 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.

  PMID: 23346989 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.

  PMID: 22617633 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.

  PMID: 26352921 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.

  PMID: 26951939 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.

  PMID: 11458859 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.

  PMID: 18395022 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.

  PMID: 22506884 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.

  PMID: 10076111 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 23, 2020
• Study Start: March 21, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)