Music Interventions During Wide-Awake Hand Surgery

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472909
• Other study ID #: 2022-0674
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Surgery

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