Trial Outcomes & Findings for Feasibility of BabyGentleStick- Adult Pilot Study (NCT NCT02947646)
NCT ID: NCT02947646
Last Updated: 2022-12-29
Results Overview
Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
24 hours after the intervention is received for each subject
Results posted on
2022-12-29
Participant Flow
Participant milestones
| Measure |
BabyGentleStick™ ON, Then BabyGentleStick™ OFF
Experimental intervention first (5 minutes), followed by Active Comparator (5 minutes).
|
BabyGentleStick™ OFF, Then BabyGentleStick™ ON
Active Comparator first (5 minutes), then Experimental intervention (5 minutes).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of BabyGentleStick- Adult Pilot Study
Baseline characteristics by cohort
| Measure |
BabyGentleStick™ ON, Then BabyGentleStick™ OFF
n=10 Participants
Experimental intervention followed by Active Comparator.
|
BabyGentleStick™ OFF, Then BabyGentleStick™ ON
n=10 Participants
Active Comparator followed by Experimental intervention.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the intervention is received for each subjectSubjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events.
Outcome measures
| Measure |
BabyGentleStick™ ON
n=19 Participants
Experimental intervention, whether it was performed first or was performed after Active Comparator
|
BabyGentleStick™ OFF
n=20 Participants
Active Comparator, whether it was performed first or was performed after Experimental intervention
|
|---|---|---|
|
Number of Adverse Events
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: 5 minutesRelative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain.
Outcome measures
| Measure |
BabyGentleStick™ ON
n=19 Participants
Experimental intervention, whether it was performed first or was performed after Active Comparator
|
BabyGentleStick™ OFF
n=20 Participants
Active Comparator, whether it was performed first or was performed after Experimental intervention
|
|---|---|---|
|
Reduced Pain Response
|
1.74 score on a Likert scale
Standard Deviation 1.45
|
1.80 score on a Likert scale
Standard Deviation 1.24
|
Adverse Events
BabyGentleStick™ ON
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BabyGentleStick™ OFF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BabyGentleStick™ ON
n=19 participants at risk
Experimental intervention to be compared to the Active Comparator.
BabyGentleStick™ ON
|
BabyGentleStick™ OFF
n=20 participants at risk
Active Comparator intervention to be compared to the Experimental interventional.
BabyGentleStick™ OFF
|
|---|---|---|
|
Blood and lymphatic system disorders
Unexpected bleeding
|
0.00%
0/19 • 1 day
|
5.0%
1/20 • 1 day
|
Additional Information
Director Quality Assurance & Regulatory Affairs
Actuated Medical
Phone: 814-355-0003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place