Music Interventions During Wide-Awake Hand Surgery
3 other identifiers
interventional
170
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
Study Completion
Last participant's last visit for all outcomes
July 1, 2027
April 30, 2026
October 1, 2025
1 year
July 21, 2022
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Visual Analog Scale-Anxiety (VAS-A) Score
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
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 Outcomes (4)
Participant Heart Rate
day 0, pre- and intraoperative
Participant Systolic Blood Pressure
pre- and intraoperative on day 0
Participant Diastolic Blood Pressure
pre- and intraoperative on day 0
Participant Respiratory Rate
pre- and intraoperative on day 0
Study Arms (2)
Standardized Relaxation Music
EXPERIMENTALPersonal Choice of Music
ACTIVE COMPARATORInterventions
Participants listen to their preferred music during surgery.
Participants listen to standardized relaxation music during surgery.
Eligibility Criteria
You may qualify if:
- Adult (18 years of age or older) patients
- Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Publications (5)
Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
PMID: 29665028BACKGROUNDPalmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.
PMID: 26282640BACKGROUNDBradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
PMID: 23740695BACKGROUNDFeneberg AC, Kappert MB, Maidhof RM, Doering BK, Olbrich D, Nater UM. Efficacy, Treatment Characteristics, and Biopsychological Mechanisms of Music-Listening Interventions in Reducing Pain (MINTREP): Study Protocol of a Three-Armed Pilot Randomized Controlled Trial. Front Psychiatry. 2020 Nov 4;11:518316. doi: 10.3389/fpsyt.2020.518316. eCollection 2020.
PMID: 33329075BACKGROUNDMitchell LA, MacDonald RA. An experimental investigation of the effects of preferred and relaxing music listening on pain perception. J Music Ther. 2006 Winter;43(4):295-316. doi: 10.1093/jmt/43.4.295.
PMID: 17348757BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Kruse, MD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2022
First Posted
July 25, 2022
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
April 30, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
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.