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Thimble Mindfulness App and Recovery Patch Descriptions

NCT05980247 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Needle Fear
  • Vaccine Hesitancy

Interventions

DEVICE

Thimble Application

Use of of thimble application to practice mindfulness before needle procedure.

Sponsors & Collaborators

  • Thimble Health

    collaborator UNKNOWN

  • Bianca Edison

    lead OTHER

Principal Investigators

  • Bianca Edison, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980247 on ClinicalTrials.gov