CClinicalTrials.gg
Status unknownNCT04636463Updated Nov 19, 2020

Music in Wide Awake Hand Surgery

An interventional study of Intraoperative Music in Hand Surgery, sponsored by Rothman Institute Orthopaedics. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Wide awake local anesthesia no tourniquet (WALANT) surgery has emerged as a popular technique in hand surgery over the last decade. It is possible that the unfamiliar sounds of the operating room could contribute to intraoperative patient anxiety during WALANT surgery. This study intends to investigate whether utilizing noise cancelling headphones and listening to music intraoperatively during WALANT hand surgery has an effect on patient anxiety, pain, and satisfaction.

02

Conditions studied

  • Hand Surgery
03

In context

Lead sponsor

Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥ 18 years old
  • Already chose to undergo WALANT hand surgery with the participating surgeon

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years old
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Hand Surgery with Music

    Participant undergoes surgery hand surgery using Wide Awake Local Anesthesia with no tourniquet (WALANT) while listing to music

    Procedure: Intraoperative Music

  • No intervention
    Hand Surgery without Music (Control Group)

    Participant undergoes surgery hand surgery using Wide Awake Local Anesthesia with no tourniquet (WALANT) without listening to music

Interventions

  • ProcedureIntraoperative Music

    Hand Surgery performed with the participant awake, using local anesthesia. Headphones will be worn by the participant and surgery will be performed while the participant is listening to music

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What researchers measure

Primary outcomes

  1. Patient anxiety levels will be recorded on a 10 point VAS scale

    Participant Satisfaction

    Time frame: 3 hours

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Study locations

1 site
  • Rothman Orthopaedic Institute
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04636463
Lead sponsor
Rothman Institute Orthopaedics
Responsible party
Sponsor
First posted
Nov 19, 2020
Start date
Nov 30, 2020 (estimated)
Primary completion
Nov 30, 2021 (estimated)
Completion
Nov 30, 2021 (estimated)
Last update
Nov 19, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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