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Cooling Device for Pain During Blood Draws
N/A
Waitlist Available
Led By Dieter Manstein, MD PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
Study Summary
This trial is testing a new pain-reducing device for needle sticks and blood draws.
Who is the study for?
This trial is for healthy adults aged 18-60 with fingers of a certain size, who consent to participate. All skin types are welcome but not if you have bleeding disorders, scar easily, take certain medications, or have had recent surgery on your hands.Check my eligibility
What is being tested?
The study tests a new cooling device applied to the finger to reduce pain during blood draws. Participants will experience this novel method and its effectiveness in managing needle stick discomfort will be assessed.See study design
What are the potential side effects?
Potential side effects may include temporary discomfort from the cold, bruising at the application site, or skin reactions in those sensitive to cold temperatures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wong-Baker FACES Pain Rating Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cooling digit device applicationExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,343 Total Patients Enrolled
Dieter Manstein, MD PhDPrincipal InvestigatorMassachusetts General Hospital
Neera Nathan, MD, MSHSPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
79 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old.My pinky finger is between 17-23mm wide at the tip.I have a bleeding disorder or take medication that could increase my risk of bruising.I am unable or unwilling to follow the study's requirements.I do not have major skin issues like open cuts or severe rashes in the area to be treated.I had surgery in the area to be treated within the last 6 months.I have a history of skin or collagen vascular diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Cooling digit device application
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research encompass participants aged 18 or over?
"The trial is open to all persons aged between 18 and 60 years old."
Answered by AI
Are there still available positions for volunteers in this research endeavor?
"According to the information hosted on clinicaltrials.gov, enrollment for this particular study has closed. It was first posted on November 20th 2022 and its last update occurred October 14th of the same year. Fortunately, another trial is recruiting patients at this time."
Answered by AI
To whom is this clinical trial open?
"Patients between 18 and 60 years of age, who have a qualifying blood type, can be accepted into this trial. At present there is need for roughly 12 participants."
Answered by AI
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