Needle FearNCT05980247
Thimble Mindfulness App and Recovery Patch Descriptions
A study testing Thimble Application in people with Needle Fear and Vaccine Hesitancy, run by Bianca Edison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Needle Fear, Vaccine Hesitancy
- What is being tested?
- Thimble Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Using a Mindfulness-Based App and Plant-Based Recovery Patch to Reduce Pain and Anxiety of Needles in the Pediatric Population
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?
Read more
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.
Read the detailed description
- This study aims to provide patients with a tool to reduce needle anxiety and establish healthy coping habits when addressing and managing fear. In addition, we will examine the utility of a plant-based post procedure patch in lessening the pain and anxiety that may stem from needle procedures.
- Patients between the ages of 5 and 11 undergoing needle-based procedures will be invited to participate. Patients will be randomized into one of four groups: control (no intervention), intervention (app), intervention (patch), or intervention (app+patch). Children and their caregivers will fill out a secure, online-based survey that includes a demographics (age, gender, ethnicity, zip code) and validated anxiety measure tool S-STAI. They will then, those who are randomized to the groups using the app will scan a QR code to quickly access the web-based app on their mobile device or through a clinic-owned iPad. They will be able to interact with the app as desired; before/during/after the needle-based procedure.
- The app opens with a note of validation presented by an inclusive character and then allows the user to choose where they are in the appointment process: Is it coming up, is it right now, or is it all done? In the preparation section one finds informative animations about how to prepare for needle procedures. Here, clear, honest language is utilized to calmly inform the child of what will take place so that expectations are managed. We encourage the child to choose an ideal comfort position and discuss their needs with the caregiver. This section can be used in the days, hours, or minutes leading up to the visit.
- Next, the platform offers steps to take during the visit. There are three steps outlined but the user can choose any module at any time. Steps 1 and 2 include exercises with engaging animations that utilize applied muscle tension techniques and breathing techniques to help relax the child. Step 3 includes an interactive short, winnable game, which is best used during the procedure to distract the child from the needle.
- Once the procedure is done, the user clicks on the after section where we celebrate and affirm the child's accomplishment. We encourage caregivers to share this proud moment with their friends and family, with the hopes of creating some virality in this movement. The "After" section is a combination of positive reinforcement, a chance to reflect on the experience, and eventually sharing success on social media.
- The post-intervention surveys will ask participants if they would be willing/interested in a short-semi-structured interview. If patients express interest, they will set up a virtual interview time/date with the research team to meet with Dr. Dawkins and Dr. Edison.
- The Recover Patch contains Arnica montana(14%), Curcuma longa (turmeric) (8.1%), Piper nigrum (black pepper)(1.0%), CoQ10 (0.3%), and acrylic adhesive (76%). The Thimble patch will be placed on the site of the needle procedure for those who are placed in the intervention arms that include the Thimble patch. Patients who receive the patch will be instructed to wear the patch for 8-48 hours total.
- After the use of the app and after their needle-based procedure, they will fill out the validated anxiety measurement tool again for post-comparison. They will also be asked to undergo an optional short semi-structured interview.
- The healthcare staff involved in providing the needle-based procedure will also be given a survey to complete to provide their feedback on the effectiveness of the app and how it impacted the appointment overall.
- Participants will also provide their email to which the post-procedure survey will be sent 24 hours after their visit. This survey aims to gather their thoughts of the clinic visit/app and/or patch the day after their needle procedure while also measuring their anxiety and pain levels.
- Conditions
- Needle Fear, Vaccine Hesitancy
- Being tested
- Thimble Application
- Keywords
- Thimble Recovery Patch, Thimble Mindfulness Application
- Medical subject headings
- Iatrophobia, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thimble ApplicationDevice
Use of of thimble application to practice mindfulness before needle procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Thimble Application |
| Use of the thimble patch but not the thimble application | Experimental | Use of the thimble patch but not the thimble application Receives: Device: Thimble Application |
| Use of both thimble application and thimble patch | Experimental | Use of both thimble application and thimble patch Receives: Device: Thimble Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured upon enrollment, immediately before needle-based procedure, immediately after needle-based procedure and 24-48 hours after procedure
Secondary outcomes (1)
Perceived Swelling
Patients and/or parents will describe whether or not they felt the patch helped provide some relief from swelling in feedback survey
Measured: 24-48 hours after needle-based procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Apr 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: No resources available to carry out the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One control group and three intervention groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bianca Edison
- Sponsor type
- University, hospital or other
- Collaborators
- Thimble Health
- Responsible party
- Sponsor-investigator, Bianca Edison, Children's Hospital Los Angeles
- Investigators
- Bianca Edison, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980247
- Sponsor's protocol ID
- CHLA-23-00176
- Status last verified
- Apr 2025
- First submitted
- 26 Jul 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Mindfulness-Based App and Plant-Based Recovery Patch to Reduce Pain and Anxiety of Needles in the Pediatric Population
- ClinicalTrials.gov ID
- NCT05980247
- Acronym / sponsor ID
- CHLA-23-00176
- Conditions
- Needle Fear, Vaccine Hesitancy
- Keywords
- Thimble Recovery Patch, Thimble Mindfulness Application
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No resources available to carry out the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bianca EdisonUniversity, hospital or other
- Collaborators
- Thimble Health
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- This study aims to provide patients with a tool to reduce needle anxiety and establish healthy coping habits when addressing and managing fear. In addition, we will examine the utility of a plant-based post procedure patch in lessening the pain and anxiety that may stem from needle procedures.
- Patients between the ages of 5 and 11 undergoing needle-based procedures will be invited to participate. Patients will be randomized into one of four groups: control (no intervention), intervention (app), intervention (patch), or intervention (app+patch). Children and their caregivers will fill out a secure, online-based survey that includes a demographics (age, gender, ethnicity, zip code) and validated anxiety measure tool S-STAI. They will then, those who are randomized to the groups using the app will scan a QR code to quickly access the web-based app on their mobile device or through a clinic-owned iPad. They will be able to interact with the app as desired; before/during/after the needle-based procedure.
- The app opens with a note of validation presented by an inclusive character and then allows the user to choose where they are in the appointment process: Is it coming up, is it right now, or is it all done? In the preparation section one finds informative animations about how to prepare for needle procedures. Here, clear, honest language is utilized to calmly inform the child of what will take place so that expectations are managed. We encourage the child to choose an ideal comfort position and discuss their needs with the caregiver. This section can be used in the days, hours, or minutes leading up to the visit.
- Next, the platform offers steps to take during the visit. There are three steps outlined but the user can choose any module at any time. Steps 1 and 2 include exercises with engaging animations that utilize applied muscle tension techniques and breathing techniques to help relax the child. Step 3 includes an interactive short, winnable game, which is best used during the procedure to distract the child from the needle.
- Once the procedure is done, the user clicks on the after section where we celebrate and affirm the child's accomplishment. We encourage caregivers to share this proud moment with their friends and family, with the hopes of creating some virality in this movement. The "After" section is a combination of positive reinforcement, a chance to reflect on the experience, and eventually sharing success on social media.
- The post-intervention surveys will ask participants if they would be willing/interested in a short-semi-structured interview. If patients express interest, they will set up a virtual interview time/date with the research team to meet with Dr. Dawkins and Dr. Edison.
- The Recover Patch contains Arnica montana(14%), Curcuma longa (turmeric) (8.1%), Piper nigrum (black pepper)(1.0%), CoQ10 (0.3%), and acrylic adhesive (76%). The Thimble patch will be placed on the site of the needle procedure for those who are placed in the intervention arms that include the Thimble patch. Patients who receive the patch will be instructed to wear the patch for 8-48 hours total.
- After the use of the app and after their needle-based procedure, they will fill out the validated anxiety measurement tool again for post-comparison. They will also be asked to undergo an optional short semi-structured interview.
- The healthcare staff involved in providing the needle-based procedure will also be given a survey to complete to provide their feedback on the effectiveness of the app and how it impacted the appointment overall.
- Participants will also provide their email to which the post-procedure survey will be sent 24 hours after their visit. This survey aims to gather their thoughts of the clinic visit/app and/or patch the day after their needle procedure while also measuring their anxiety and pain levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- One control group and three intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No application and no thimble patch. |
| Use of the thimble application but not the thimble patch | Experimental | Device: Thimble ApplicationUse of the thimble application but not the thimble patch |
| Use of the thimble patch but not the thimble application | Experimental | Device: Thimble ApplicationUse of the thimble patch but not the thimble application |
| Use of both thimble application and thimble patch | Experimental | Device: Thimble ApplicationUse of both thimble application and thimble patch |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thimble ApplicationUse of of thimble application to practice mindfulness before needle procedure. | Device | 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 |
Primary outcome
Scores from the State Trait Anxiety Inventory for Children (STAI-C)
Time frame: Measured upon enrollment, immediately before needle-based procedure, immediately after needle-based procedure and 24-48 hours after procedure
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.
1 secondary outcome
Perceived Swelling
Time frame: 24-48 hours after needle-based procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bianca Edison, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thimble Application in people with Needle Fear and Vaccine Hesitancy, run by Bianca Edison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores from the State Trait Anxiety Inventory for Children (STAI-C) (time frame: Measured upon enrollment, immediately before needle-based procedure, immediately after needle-based procedure and 24-48 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.