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NCT Number: NCT05472909

Music Interventions During Wide-Awake Hand Surgery

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized Relaxation Music

Other

Participants listen to standardized relaxation music during surgery.

Personal Choice of Music

Other

Participants listen to their preferred music during surgery.

Primary outcomes

  1. 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'.

  2. 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Schjei

CONTACT

[email protected]

608-234-6719

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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