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NCT04636463 Clinical Trial

Music in Wide Awake Hand Surgery

Hand Surgery Clinical Trial

Official title:
Music in Wide Awake Local Anesthesia no Tourniquet (WALANT) Hand Surgery: Prospective Randomized Control Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04636463
Other study ID # AILY20D.1059
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date November 30, 2021

Study information
Verified date November 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old - Already chose to undergo WALANT hand surgery with the participating surgeon Exclusion Criteria: - Age <18 years old

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intraoperative 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

Locations
Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient anxiety levels will be recorded on a 10 point VAS scale Participant Satisfaction 3 hours
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