The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
Overview
- Phase
- Phase 4
- Intervention
- External thermomechanical device delivering cold and vibration stimuli
- Conditions
- Nail Diseases
- Sponsor
- Weill Medical College of Cornell University
- Locations
- 1
- Primary Endpoint
- The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of a thermomechanical device delivering vibration and cold stimuli in lowering pain during intramatricial nail injections
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women aged 18 years or older
- •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
- •Inability of the patient to provide written informed consent for any reason
- •Failure to have nail injection performed
- •Likely inability to comply with the study protocol or cooperate fully with the research team
Arms & Interventions
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.
Intervention: External thermomechanical device delivering cold and vibration stimuli
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.
Intervention: External thermomechanical device without delivering cold and vibration stimuli
Nail injection with ethyl chloride skin refrigerant spray
Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
Intervention: Ethyl chloride skin refrigerant spray
Outcomes
Primary Outcomes
The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.
Time Frame: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
Pain will be self-reported, using the Wong-Baker FACES (0-10, with 0 representing absence of pain and 10 unbearable pain). Participants will be questioned about their level of pain in their nail prior to treatment, immediately after the needle insertion, during infiltration, and 5 seconds after needle extraction
Secondary Outcomes
- Number of participants with at least one adverse event(Patients will be followed for 3 days following their nail injection)