Trial Outcomes & Findings for A Novel Cooling Device for Pain Management During Fingerstick Blood Draw (NCT NCT05329493)
NCT ID: NCT05329493
Last Updated: 2025-02-13
Results Overview
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.
COMPLETED
NA
6 participants
day 1
2025-02-13
Participant Flow
Unit of analysis: fingers
Participant milestones
| Measure |
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.
|
Control
All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.
|
|---|---|---|
|
Overall Study
STARTED
|
6 6
|
6 6
|
|
Overall Study
COMPLETED
|
6 6
|
6 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
Baseline characteristics by cohort
| Measure |
Cooling Digit Device Application
n=6 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1This 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.
Outcome measures
| Measure |
Cooling Digit Device Application
n=6 fingers
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.
|
Control
n=6 fingers
All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.
|
|---|---|---|
|
Wong-Baker FACES Pain Rating Scale
|
1.2 score on a scale
Standard Deviation 0.8
|
2.4 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 1After 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.
Outcome measures
| Measure |
Cooling Digit Device Application
n=6 fingers
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.
|
Control
n=6 fingers
All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.
|
|---|---|---|
|
Blood Absorption Via Whatman 903 Filter Paper (Surface Area)
|
1.4 cm^2
Standard Deviation 0.8
|
1.1 cm^2
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 1After 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.
Outcome measures
| Measure |
Cooling Digit Device Application
n=6 fingers
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.
|
Control
n=6 fingers
All study participants will have their fifth or third finger pricked. Subjects will serve as their own control.
|
|---|---|---|
|
Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)
|
11.4 number of drops
Standard Deviation 2.5
|
12.4 number of drops
Standard Deviation 8.4
|
Adverse Events
Cooling Digit Device Application
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place