Thimble Mindfulness App and Recovery Patch Descriptions

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2023
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.
Epistemonikos ID: e66c4b07d9bc16a6ac242a00a824094073a4a13f
First added on: May 15, 2024