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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05472909
Other study ID # 2022-0674
Secondary ID Protocol Version
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date May 2025

Study information

Verified date June 2024
Source University of Wisconsin, Madison
Contact Katie Schjei
Phone 608-234-6719
Email Schjei@ortho.wisc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Participant Heart Rate day 0, pre- and intraoperative
Secondary Participant Systolic Blood Pressure pre- and intraoperative on day 0
Secondary Participant Diastolic Blood Pressure pre- and intraoperative on day 0
Secondary Participant Respiratory Rate pre- and intraoperative on day 0
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