Music Interventions During Wide-Awake Hand Surgery

April 24, 2026 updated by: University of Wisconsin, Madison

Music Interventions During Wide-Awake Hand Surgery: A Randomized Controlled Trial

The purpose of this study is to examine if patients have a lower anxiety level during wide awake hand surgery while listening to their choice of music vs standardized relaxation music. Patients who are planning to undergo wide awake (local anesthetic only hand surgery) and agree to participate will be randomized to either a music intervention where they listen to their choice of music genre or standardized relaxation music during their time in the operating room. 170 participants will be enrolled and can expect to be on study for 2 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Music has been shown to decrease anxiety and pain during surgery. Wide awake local anesthesia no tourniquet (WALANT) surgery on the hand is gaining popularity due to efficiency, cost savings and patient safety.

Despite the popularity of WALANT, it still can be anxiety producing even for patients who choose to proceed with surgery without sedation. Music has been shown to decrease anxiety during surgery, but patients' music choices vary widely. The frequency (Hz) of the music intervention has been shown to impact pain reduction, and patient choice of music has been shown to increase sense of control which can decrease anxiety. No study has evaluated the intraoperative effect of patient choice of music vs standardized relaxation music on intraoperative anxiety.

The primary objective of this research is to compare the effect of patient music choice vs standardized relaxation music played during surgery on anxiety levels in patients undergoing WALANT hand surgery. The investigators hypothesize that standardized relaxation music will result in reduced anxiety compared to patient's choice of music.

Study Type

Interventional

Enrollment (Estimated)

170

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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (18 years of age or older) patients
  • Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery

Exclusion Criteria:

  • Patients under the age of 18
  • Patients unable to consent for themselves
  • Patients unwilling to consent
  • Non-English speaking patients
  • Patients with significant hearing impairment not able to be corrected with assistive devices

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: Standardized Relaxation Music
Other: Standardized Relaxation Music
Participants listen to standardized relaxation music during surgery.
Active Comparator: Personal Choice of Music
Other: Personal Choice of Music
Participants listen to their preferred music during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale-Anxiety (VAS-A) Score
Time Frame: day 0 post-operative, up to day 14
The VAS-A is scored from 0-10 where 0 is 'feeling calm' and 10 is 'extremely anxious'.
day 0 post-operative, up to day 14
Change in State Trait Anxiety Inventory (STAI) Score
Time Frame: day 0 post-operative, up to day 14
The STAI is a 20-item questionnaire (form Y-1) scored on a 4 point likert scale where 1 is 'not at all', 2 is 'somewhat', 3 is 'moderately so', and 4 is 'very much so' for a total possible range of scores from 20-80 where higher scores indicate increased anxiety.
day 0 post-operative, up to day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant Heart Rate
Time Frame: day 0, pre- and intraoperative
day 0, pre- and intraoperative
Participant Systolic Blood Pressure
Time Frame: pre- and intraoperative on day 0
pre- and intraoperative on day 0
Participant Diastolic Blood Pressure
Time Frame: pre- and intraoperative on day 0
pre- and intraoperative on day 0
Participant Respiratory Rate
Time Frame: pre- and intraoperative on day 0
pre- and intraoperative on day 0

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Lisa Kruse, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

July 21, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0674
  • A536100 (Other Identifier: UW Madison)
  • Protocol Version 4/7/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will not be shared with patients or their primary care physicians. Study results will be shared via manuscript publication in a peer reviewed journal. Data will be pooled and deidentified. No individual results will be shared.

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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