CClinicalTrials.gg
RecruitingNCT05472909Updated Sep 29, 2026

Music Interventions During Wide-Awake Hand Surgery

An interventional study of Standardized Relaxation Music and Personal Choice of Music in Anxiety and Surgery, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety
  • Surgery

Browse trials for

Keywords

  • wide-awake hand surgery
  • music intervention
  • patient care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Standardized Relaxation Music

    Other: Standardized Relaxation Music

  • Active comparator
    Personal Choice of Music

    Other: Personal Choice of Music

Interventions

  • OtherStandardized Relaxation Music

    Participants listen to standardized relaxation music during surgery.

  • OtherPersonal Choice of Music

    Participants listen to their preferred music during surgery.

05

What researchers measure

Primary outcomes

  1. 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'.

    Time frame: day 0 post-operative, up to day 14

  2. 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.

    Time frame: day 0 post-operative, up to day 14

Secondary outcomes

  1. Participant Heart Rate

    Time frame: day 0, pre- and intraoperative

  2. Participant Systolic Blood Pressure

    Time frame: pre- and intraoperative on day 0

  3. Participant Diastolic Blood Pressure

    Time frame: pre- and intraoperative on day 0

  4. Participant Respiratory Rate

    Time frame: pre- and intraoperative on day 0

06

Study locations

1 of 1 sites recruiting
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
    Recruiting
07

References and documents

Publications

  • 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. PubMed 29665028 ↗
  • Palmer 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. PubMed 26282640 ↗
  • Bradt 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. PubMed 23740695 ↗
  • Feneberg 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. PubMed 33329075 ↗
  • Mitchell 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. PubMed 17348757 ↗

Individual participant data

Plan to share: No — 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.

08

Registry details

Key details

Study ID
NCT05472909
Lead sponsor
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Jul 25, 2022
Start date
Jan 2027 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Katie Schjei
Contact
Schjei@ortho.wisc.edu
608-234-6719
Lisa Kruse, MD
principal investigator · University of Wisconsin, Madison

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion