A Novel Cooling Device for Pain Management During Fingerstick Blood Draw

Study Overview
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Brief Summary
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In this study, the investigators seek to evaluate a novel tissue-cooling device for pain management during needle sticks and /or blood draw on the fingertips.

Detailed Description
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Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory's ability to provide testing to patients and health care providers.The fingerstick blood draw has been used as an alternative. Aiming a less painful, potentially easier alternative we devised a novel that can be applied distally on the digit prior to the blood collection procedure and may provide analgesia through a liquid coolant that is run through tubes in the device to safely cool tissue to achieve numbing. We hypothesize that this device will safely and effectively reduce the pain associated with the fingertip pricks and increase the amount of capillary blood collected. Multiple punctures with a large lancet were a frequent cause of discomfort among patients.With this new device the discomfort will be reduced by its application followed by the numbness of the finger. The investigators plan to have 12 patients to complete the study. Subjects must be equal to greater than 18 years old and younger than 60 years older and may be any gender or Fitzpatrick skin type.

Official Title
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A Novel Cooling Device for Pain Management During Fingerstick Blood Draw

Conditions
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Blood

Intervention / Treatment
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* Device: Cooling digit device application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent to participate in the study. Male or Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment. All Fitzpatrick Skin Types are eligible General good health confirmed by medical history and skin examination of the area to be treated Subjects fifth finger is 17-23mm in diameter at the distal phalanges. Exclusion Criteria: • Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months. Sensitivity to the cold or history of cold-induced diseases including Raynaud's disease and cryoglobulinemia Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course. History of keloid scarring, abnormal wound healing and /or prone to bruising. History of epidermal or dermal disorders (Particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitis disorders Subject is unable or unwilling to comply with the study requirements. Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device. Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cooling digit device application<br>Device: Cooling digit device. The cooling finger device will be applied in the subjects on their right hand. Subjects will serve as their own control. | Device: Cooling digit device application<br>* Cooling digit device will be applied on subject's right hand ( fifth finger).<br>* Other names: cooling finger device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker FACES Pain Rating Scale | This scale will be used to record subject pain from the overall pain from the procedure. There are 6 faces ranging from 0 no hurt to 10 hurts the worst. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Draw, Fingerstick Blood Draw