Music Interventions During Wide-Awake Hand Surgery

Study Overview
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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.

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

Conditions
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Anxiety, Surgery

Intervention / Treatment
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* Other: Standardized Relaxation Music
* Other: Personal Choice of Music


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized Relaxation Music<br> | Other: Standardized Relaxation Music<br>* Participants listen to standardized relaxation music during surgery.<br>|
| Active Comparator: Personal Choice of Music<br> | Other: Personal Choice of Music<br>* Participants listen to their preferred music during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Heart Rate |  | day 0, pre- and intraoperative | 
| Participant Systolic Blood Pressure |  | pre- and intraoperative on day 0 | 
| Participant Diastolic Blood Pressure |  | pre- and intraoperative on day 0 | 
| Participant Respiratory Rate |  | pre- and intraoperative on day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient care, wide-awake hand surgery, music intervention