NCT04636463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 18, 2020

Last Update Submit

November 18, 2020

Conditions

Hand Surgery

Outcome Measures

Primary Outcomes (1)

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

    Participant Satisfaction

    3 hours

Study Arms (2)

Hand Surgery with Music

EXPERIMENTAL

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

Procedure: Intraoperative Music

Hand Surgery without Music (Control Group)

NO INTERVENTION

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

Interventions

Intraoperative MusicPROCEDURE

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 with Music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Age \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 19, 2020

Study Start

November 30, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

US(1)