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Behavioural Intervention
Thimble App for Needle Phobia
N/A
Waitlist Available
Led By Bianca Edison, MD
Research Sponsored by Bianca Edison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours after needle-based procedure
Awards & highlights
Study Summary
This trial aims to reduce fear and pain of needles in kids ages 5-11 using an app and patch. Researchers will compare groups to see if the interventions help.
Who is the study for?
This trial is for children aged 5-11 undergoing simple needle procedures, like vaccinations or blood draws. They must be able to use an app and speak English. It's not for kids with allergies to the patch ingredients, under 5 or over 12 years old, pregnant women, prisoners, those unable to consent, or non-English speakers.Check my eligibility
What is being tested?
The study tests if a mindfulness app and a natural ingredient recovery patch can reduce needle fear and pain in kids. Participants are randomly placed into four groups: no treatment (control), just the app (Experimental-App), just the patch (Experimental-Patch), or both (Experimental-Patch and App).See study design
What are the potential side effects?
There may be minimal side effects since the interventions involve a mindfulness app and a natural ingredient recovery patch; however specific side effects are not listed but could include skin irritation from the patch.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours after needle-based procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours after needle-based procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Scores from the State Trait Anxiety Inventory for Children (STAI-C)
Secondary outcome measures
Perceived Swelling
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Use of the thimble patch but not the thimble applicationExperimental Treatment1 Intervention
Use of the thimble patch but not the thimble application
Group II: Use of the thimble application but not the thimble patchExperimental Treatment1 Intervention
Use of the thimble application but not the thimble patch
Group III: Use of both thimble application and thimble patchExperimental Treatment1 Intervention
Use of both thimble application and thimble patch
Group IV: ControlActive Control1 Intervention
No application and no thimble patch.
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Who is running the clinical trial?
Thimble HealthUNKNOWN
Bianca EdisonLead Sponsor
Bianca Edison, MDPrincipal InvestigatorChildren's Hospital Los Angeles
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a needle-based procedure as part of a larger treatment.I am a healthcare worker who performs procedures using needles.I speak English.I am not scheduled for any needle-based medical procedures.I can use and navigate apps on a smartphone or tablet.I speak a language other than English.I am either younger than 5 or older than 12 years old.I am a parent and I am over 18 years old.I am having a simple outpatient procedure.I am between 5 and 11 years old and need a procedure involving a needle.I am able to understand and use the app required for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Use of the thimble patch but not the thimble application
- Group 2: Use of the thimble application but not the thimble patch
- Group 3: Control
- Group 4: Use of both thimble application and thimble patch
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 trial have any age restrictions, particularly for elderly patients?
"This clinical trial has an age limit of 5 and 11 years old. All participants must be within this range to qualify for enrollment."
Answered by AI
May I join this experiment as a participant?
"This medical trial necessitates participants who demonstrate a wariness of vaccines and are aged between 5 to 11 years. Currently, 60 patients can join the study."
Answered by AI
Is this experimental protocol still open to recruitment?
"This experiment is not currently searching for participants, as indicated on clinicaltrials.gov. Originally posted in August of 2023 and last updated July 26th of the same year, it appears that this trial has paused recruitment while 9 other trials remain open to applicants."
Answered by AI
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