A Novel Cooling Device for Pain Management During Fingerstick Blood Draw

Not Applicable

Completed

• Conditions: Blood
• Interventions: Device: Cooling digit device application

• Registration Number: NCT05329493
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-15
• Study Start: 2023-06-21
• Primary Completion: 2024-11-08
• Study Completion: 2024-11-08
• Results First Submitted: 2024-12-18
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Results First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cooling digit device application	Cooling digit device application	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.

Primary Outcome Measures

Name	Time	Method
Wong-Baker FACES Pain Rating Scale	day 1	This scale will be used to record subject pain from the overall pain from the procedure for the treatment and control finger. There are 6 faces ranging from 0 no hurt to 10 hurts the worst.

Secondary Outcome Measures

Name	Time	Method
Blood Absorption Via Whatman 903 Filter Paper (Surface Area)	Day 1	After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.
Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)	Day 1	After the finger has been pricked, the finger will subsequently be held over a single-use Whatman 903 filter paper. Approximately every ten seconds after the prick, the filter paper will be gently applied to the blood drop to absorb the blood. This will be repeated on new locations of the filter paper until blood flow stops. At least one Whatman 903 filter paper will be used per finger prick. The Whatman 903 filter paper will be imaged.

Trial Locations

Locations (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin; 🇺🇸 Boston, Massachusetts, United States