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Music in Wide Awake Hand Surgery

NCT ID: NCT04636463

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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Hand Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hand Surgery with Music

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

Group Type EXPERIMENTAL

Intraoperative Music

Intervention Type PROCEDURE

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

Hand Surgery without Music (Control Group)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Age \<18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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AILY20D.1059

Identifier Type: -

Identifier Source: org_study_id