Music Interventions During Wide-Awake Hand Surgery

NCT ID: NCT05472909

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standardized Relaxation Music

Group Type EXPERIMENTAL

Standardized Relaxation Music

Intervention Type OTHER

Participants listen to standardized relaxation music during surgery.

Personal Choice of Music

Group Type ACTIVE_COMPARATOR

Personal Choice of Music

Intervention Type OTHER

Participants listen to their preferred music during surgery.

Interventions

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Standardized Relaxation Music

Participants listen to standardized relaxation music during surgery.

Intervention Type OTHER

Personal Choice of Music

Participants listen to their preferred music during surgery.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Kruse, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katie Schjei

Role: CONTACT

608-234-6719

References

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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.

Reference Type BACKGROUND
PMID: 29665028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26282640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23740695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33329075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17348757 (View on PubMed)

Other Identifiers

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Protocol Version 4/7/2023

Identifier Type: OTHER

Identifier Source: secondary_id

A536100

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0674

Identifier Type: -

Identifier Source: org_study_id

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