Effect of Music on Pain and Anxiety During Nail Biopsies

This study is looking at whether listening to music during a nail biopsy can reduce pain and anxiety. Patients scheduled for a nail biopsy at the Weill Cornell Medicine dermatology clinic will be randomly assigned to either listen to a calming instrumental/classical music playlist during their procedure or receive standard care without music. After the procedure, participants will complete short questionnaires rating their pain, anxiety, and overall satisfaction. The goal is to determine whether a simple, low-cost music intervention can improve the experience of patients undergoing nail biopsies.

Study Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ≥18 years of age
  • Scheduled to undergo nail biopsy at the Weill Cornell Medicine dermatology clinic
  • Able to provide informed consent
  • Able to read and understand English

Exclusion Criteria:

  • Significant hearing impairment that would prevent ability to hear the music intervention
  • Cognitive impairment that would prevent completion of study questionnaires
  • Unable or unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Intervention
Participants listen to a standardized instrumental/classical/relaxing music playlist beginning 2-3 minutes before local anesthesia and continuing throughout the nail biopsy procedure.
A standardized playlist of instrumental, classical, and relaxing music delivered to participants beginning 2-3 minutes before local anesthesia administration and continuing throughout the nail biopsy procedure. The music is intended to reduce procedural pain and anxiety as an adjunct to standard care.
Local anesthesia injections
Other: Standard care/ control
Participants receive standard care during nail biopsy without any music intervention. No music is played during local anesthesia administration or the procedure.
Local anesthesia injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pain intensity measured by Visual Analog Scale
Time Frame: Immediately after the nail biopsy procedure
Total scores range from 0-10 with 10 meaning worst pain imaginable
Immediately after the nail biopsy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean anxiety score measured by short-form State-Trait Anxiety Inventory
Time Frame: Immediately after the nail biopsy procedure
Total scores range from 20 - 80 with scores higher than 34 - 36 indicating anxiety
Immediately after the nail biopsy procedure
Perceived helpfulness of music intervention (music group only) measured by single-item Likert scale
Time Frame: Immediately after the nail biopsy procedure
Likert scale ranges from 1 (not helpful at all) to 5 (extremely helpful).
Immediately after the nail biopsy procedure
Patient satisfaction score measured by single-item Likert scale rating overall experience
Time Frame: Immediately after the nail biopsy procedure
1=very dissatisfied to 5=very satisfied
Immediately after the nail biopsy procedure
Willingness to undergo future nail biopsy procedures measured by single-item yes/no question
Time Frame: Immediately after the nail biopsy procedure
Immediately after the nail biopsy procedure
Number of participants with adverse events related to the procedure
Time Frame: immediately after the nail biopsy procedure
immediately after the nail biopsy procedure
Number of participants with adverse events related to the music intervention
Time Frame: Immediately after nail biopsy procedure
Immediately after nail biopsy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shari R Lipner, MD, PhD, Weill Cornell Medicine, Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25-12029644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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