- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04636463
Music in Wide Awake Hand Surgery
November 18, 2020 updated by: Rothman Institute Orthopaedics
Music in Wide Awake Local Anesthesia no Tourniquet (WALANT) Hand Surgery: Prospective Randomized Control Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Rothman Orthopaedic Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Already chose to undergo WALANT hand surgery with the participating surgeon
Exclusion Criteria:
- Age <18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hand Surgery with Music
Participant undergoes surgery hand surgery using Wide Awake Local Anesthesia with no tourniquet (WALANT) while listing to 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient anxiety levels will be recorded on a 10 point VAS scale
Time Frame: 3 hours
|
Participant Satisfaction
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 30, 2020
Primary Completion (Anticipated)
November 30, 2021
Study Completion (Anticipated)
November 30, 2021
Study Registration Dates
First Submitted
November 18, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 19, 2020
Study Record Updates
Last Update Posted (Actual)
November 19, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- AILY20D.1059
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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