Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooling digit device application | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cooling digit device application | Device | Cooling digit device will be applied on subject's right hand ( fifth finger). |
|
| 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 for the treatment and control finger. There are 6 faces ranging from 0 no hurt to 10 hurts the worst. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Absorption Via Whatman 903 Filter Paper (Surface Area) | 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. |
Not provided
Inclusion Criteria:
Signed informed consent to participate in the study.
Exclusion Criteria:
• Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dieter Manstein, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Clinical Unit for Research Trials & Outcomes in Skin | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33009571 | Background | Jankowski CA, Casapao AM, Siller S, Isache C, Cani KV, Claudio AM, Brown M, Milstid B, Feldhammer M. Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients. Am J Clin Pathol. 2021 Feb 11;155(3):412-417. doi: 10.1093/ajcp/aqaa138. | |
| 29705575 | Background |
Not provided
Not provided
There is no plan to make individual participant data (IPD) available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cooling Digit Device Application | The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control. |
| FG001 | Control | All study participants will have their fifth or third finger pricked. Subjects will serve as their own control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Cooling digit device application: Cooling digit device will be applied on subject's right hand ( fifth finger). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wong-Baker FACES Pain Rating Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | day 1 | fingers | fingers |
|
31 days
Minimal-risk study with healthy participants. Evaluations were ongoing throughout the study to detect adverse events and changes in existing medical conditions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cooling Digit Device Application | The cooling finger device will be applied to all study participants on their hand (fifth or third finger). The hand picked will be randomized and opposite to that of the control hand. Subjects will serve as their own control. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dieter Manstein | Massachusetts General Hospital | 617-726-4893 | dmanstein@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2023 | Dec 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2023 | Dec 4, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1 |
| Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood) | 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. | Day 1 |
| Kertes DA, Kamin HS, Liu J, Bhatt SS, Kelly M. Putting a finger on the problem: Finger stick blood draw and immunization at the well-child exam elicit a cortisol response to stress among one-year-old children. Psychoneuroendocrinology. 2018 Jul;93:103-106. doi: 10.1016/j.psyneuen.2018.04.021. Epub 2018 Apr 22. |
| 29162770 | Background | Iwasawa H, Nishimura T, Nemoto S, Aikawa N, Watanabe K. Correlation of the Blood Test Results Obtained between Assays Using Microliter-scale Fingertip Blood Samples Collected with a Novel Blood Collection Device and Conventional Venous Blood Assays: a Secondary Publication in English. Keio J Med. 2018 Jun 25;67(2):26-34. doi: 10.2302/kjm.2017-0009-OA. Epub 2017 Nov 21. |
| 24800498 | Background | Sugimoto S, Tateishi A, Osawa S. [Development of the fingertip blood dilution method for blood cell counting]. Rinsho Byori. 2014 Mar;62(3):235-40. Japanese. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Blood Absorption Via Whatman 903 Filter Paper (Surface Area) | 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. | Posted | Mean | Standard Deviation | cm^2 | Day 1 | fingers | fingers |
|
|
|
| Secondary | Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood) | 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. | Posted | Mean | Standard Deviation | number of drops | Day 1 | fingers | fingers |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | All study participants will have their fifth or third finger pricked. Subjects will serve as their own control. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided