The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
NCT ID: NCT04422795
Last Updated: 2023-04-07
Study Results
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2024-02-29
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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External thermomechanical device delivering stimuli
The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.
External thermomechanical device delivering cold and vibration stimuli
the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal
External thermomechanical device without delivering stimuli
The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.
External thermomechanical device without delivering cold and vibration stimuli
the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal
Nail injection with ethyl chloride skin refrigerant spray
Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
Ethyl chloride skin refrigerant spray
Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion
Interventions
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External thermomechanical device delivering cold and vibration stimuli
the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal
External thermomechanical device without delivering cold and vibration stimuli
the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal
Ethyl chloride skin refrigerant spray
Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion
Eligibility Criteria
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Inclusion Criteria
* Must understand and voluntarily sign an informed consent form
* All patients undergoing intramatricial nail injections at the Weill Cornell Medicine (WCM) Department of Dermatology
* Willingness to participate in the study
Exclusion Criteria
* Failure to have nail injection performed
* Likely inability to comply with the study protocol or cooperate fully with the research team
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Shari R Lipner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medicine
New York, New York, United States
Countries
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Other Identifiers
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20-03021647
Identifier Type: -
Identifier Source: org_study_id
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