Clinical trial NCT05472909: Music Interventions During Wide-Awake Hand Surgery
Official title: Music Interventions During Wide-Awake Hand Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Surgery
Keywords: wide-awake hand surgery
music intervention
patient care
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analog Scale-Anxiety (VAS-A) Score
timeFrame: day 0 post-operative, up to day 14
measure: Change in State Trait Anxiety Inventory (STAI) Score
timeFrame: day 0 post-operative, up to day 14
Secondary outcomes:
measure: Participant Heart Rate
timeFrame: day 0, pre- and intraoperative
measure: Participant Systolic Blood Pressure
timeFrame: pre- and intraoperative on day 0
measure: Participant Diastolic Blood Pressure
timeFrame: pre- and intraoperative on day 0
measure: Participant Respiratory Rate
timeFrame: pre- and intraoperative on day 0
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lisa Kruse, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.