We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Music in Wide Awake Hand Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636463
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE November 18, 2020
First Posted Date  ICMJE November 19, 2020
Last Update Posted Date November 19, 2020
Estimated Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
Patient anxiety levels will be recorded on a 10 point VAS scale [ Time Frame: 3 hours ]
Participant Satisfaction
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Music in Wide Awake Hand Surgery
Official Title  ICMJE Music in Wide Awake Local Anesthesia no Tourniquet (WALANT) Hand Surgery: Prospective Randomized Control Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hand Surgery
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Hand Surgery with Music
    Participant undergoes surgery hand surgery using Wide Awake Local Anesthesia with no tourniquet (WALANT) while listing to music
    Intervention: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 18, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

- Age <18 years old

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04636463
Other Study ID Numbers  ICMJE AILY20D.1059
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP