Thimble Mindfulness App and Recovery Patch Descriptions

NCT05980247 | Withdrawn DMC

• 1 other identifier: CHLA-23-00176
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thimble Recovery Patch; Thimble Mindfulness Application

Outcome Measures

Primary Outcomes (1)

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

  Measures anxiety in children. Children respond to the STAI-C by selecting one of three choices for each item that best represents how they feel. Each STAI-C item is measured on a 3-point rating scale for which each response is assigned values of either 1, 2, or 3. Scores on the STAI-C range from a minimum of 20 to a maximum of 60. Higher scores indicate greater levels of anxiety.

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

Secondary Outcomes (1)

• Perceived Swelling

  24-48 hours after needle-based procedure

Study Arms (4)

Control

NO INTERVENTION

No application and no thimble patch.

Use of the thimble application but not the thimble patch

EXPERIMENTAL

Use of the thimble application but not the thimble patch

Device: Thimble Application

Use of the thimble patch but not the thimble application

EXPERIMENTAL

Use of the thimble patch but not the thimble application

Device: Thimble Application

Use of both thimble application and thimble patch

EXPERIMENTAL

Use of both thimble application and thimble patch

Device: Thimble Application

Interventions

Thimble Application DEVICE

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

Use of both thimble application and thimble patch; Use of the thimble application but not the thimble patch; Use of the thimble patch but not the thimble application

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bianca Edison: lead
• Thimble Health: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Iatrophobia; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bianca Edison, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One control group and three intervention groups.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 7, 2023
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)