WithdrawnNot Applicable

Thimble Mindfulness App and Recovery Patch Descriptions

Stopped: No resources available to carry out the trial.

United States0Started 2025-04-01

Plain-language summary

The goal of this clinical trial is to lessen the pain and fear of needles by using a mindfulness-based app and a recovery patch on pediatric patients between the ages of 5 and 11. The main questions it aims to answer are: * Can guided mindfulness practices lessen the fear of needles experienced among pediatric patients? * Can a recovery patch with natural ingredients lessen the pain derived from needle-based procedures when placed on the site of the needle wound? Participants will be asked to be part of a clinical trial in which they will be picked to be in one of four groups: control (no use of the patch or app), use of Thimble Mindfulness App only (Experimental- App), use of Thimble Recovery Patch only (Experimental-Patch), or use of both Thimble Mindfulness App and Recovery Patch (Experimental-Patch and App). Patients will be asked to: * Complete a survey at enrollment (demographics + State-Trait Anxiety Inventory for Children (STAI-C)) * If the experimental group with the app, they will use the app before, during, and after their needle-based procedure. * Complete another survey immediately before needle procedure (STAI-C survey) * If in experimental group with the patch, they will allow the doctor or nurse to apply the Recovery Patch on the site of the needle wound. * Complete a survey immediately after needle procedure (STAI-C survey) and app/patch feedback (if assigned to app and/or patch group) * Complete another survey 24-48 hours after needle procedure (STAI-C survey) and app/patch feedback (if assigned to app and/or patch group) Researchers will compare the 4 groups to see if these interventions (alone or together) improve anxiety and pain associated with needle-based procedures within the pediatric population.

Who can participate

Age range5 Years – 11 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients between the ages of 5 and 11 undergoing a needle-based procedure. (eg. vaccination administration, medication administration, blood draws) * Parents over the age of 18 years. * Patients with the cognitive ability to use and navigate the app. * Patients with non-complex outpatient procedures * English-speaking patients * Healthcare staff performing needle-based procedures Exclusion Criteria: * Patients under the age of 5 or older than 12. Patients who are not undergoing a needle-based procedure. * Pregnant women, prisoners, and adults unable to consent will not be included in this study. * Patients lacking the cognitive ability to use and navigate the app * Patients undergoing needle-based procedure as part of a more complex or inpatient procedure. * Patients speaking any other language other than English. * Healthcare staff other than those performing the needle-based procedures. * Patients who report an allergy to any of the ingredients listed in the Thimble Recovery Patch

What they're measuring

Scores from the State Trait Anxiety Inventory for Children (STAI-C)

Timeframe: Measured upon enrollment, immediately before needle-based procedure, immediately after needle-based procedure and 24-48 hours after procedure

Trial details

NCT IDNCT05980247

SponsorBianca Edison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01