Music Interventions During Wide-Awake Hand Surgery

ConditionsAnxietySurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult (18 years of age or older) patients

Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery

Disqualifiers

Patients under the age of 18

Patients unable to consent for themselves

Patients unwilling to consent

Non-English speaking patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized Relaxation Music

    Other intervention

    Participants listen to standardized relaxation music during surgery.

  • Personal Choice of Music

    Other intervention

    Participants listen to their preferred music during surgery.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Standardized Relaxation MusicExperimental treatment 1 intervention
Group B: Personal Choice of MusicActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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'.

Time frame
day 0 post-operative, up to day 14
2

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.

Time frame
day 0 post-operative, up to day 14

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

Other outcomes

Sponsors and contacts

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