Diabete Type 1NCT07239700
Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear
A study testing Buzzy, TickleFlex and None (Routine Care) in people with Diabete Type 1 and Diabetes in Children, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This interventional randomized controlled clinical trial aims to evaluate the effectiveness of two nonpharmacological devices, Buzzy and TickleFlex, in reducing pain and fear associated with insulin injections among children with Type 1 Diabetes Mellitus (T1DM). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 1, Diabetes in Children
- What is being tested?
- Buzzy, TickleFlex and None (Routine Care)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 12 years.
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 6 months.
- Receiving daily subcutaneous insulin injections as part of routine diabetes management.
- Able to understand and communicate pain and fear levels using the Wong-Baker -FACES Pain Rating Scale and the Children's Fear Scale.
- Accompanied by a parent or legal guardian who can provide informed consent.
- Willingness of both the child and parent to participate in the study.
- No visual, auditory, or cognitive impairments that would interfere with data collection.
Who cannot join
- Presence of neurological, sensory, or cognitive disorders that may affect pain or fear perception.
- Peripheral neuropathy or other diabetic complications influencing pain sensation.
- Use of analgesics, sedatives, or anxiolytic medications within 24 hours prior to data collection.
- Local skin lesions, infections, or allergies at or near the insulin injection site.
- History of needle phobia or severe anxiety disorders diagnosed by a healthcare professional.
- Concurrent participation in another interventional clinical study.
- Refusal or inability of the child or parent/guardian to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Buzzy and TickleFlex Applications in Reducing Pain and Fear Associated With Insulin Injections in Children With Type 1 Diabetes
This interventional randomized controlled clinical trial aims to evaluate the effectiveness of two nonpharmacological devices, Buzzy and TickleFlex, in reducing pain and fear associated with insulin injections among children with Type 1 Diabetes Mellitus (T1DM).
A total of 90 participants aged 6 to 12 years will be randomly assigned to one of three groups: Buzzy, TickleFlex, or control. The Buzzy device provides combined cold and vibration stimulation near the injection site to decrease pain perception based on the gate control theory, while the TickleFlex device is a soft, flexible attachment for insulin pens designed to minimize needle pressure and discomfort during injection.
Read more
Pain and fear will be assessed immediately before and after a single insulin injection using validated instruments, including the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale (CFS), rated independently by the child, parent, and researcher.
It is hypothesized that both Buzzy and TickleFlex applications will significantly reduce pain and fear compared to standard insulin injection without intervention. The study is expected to provide evidence supporting the use of nonpharmacological methods in pediatric diabetes care to improve children's comfort and treatment adherence.
Read the detailed description
Children with Type 1 Diabetes Mellitus (T1DM) require multiple daily insulin injections, which are often associated with pain, fear, and anxiety. Repeated exposure to needle-related discomfort can negatively affect children's treatment adherence, emotional well-being, and overall quality of life. Therefore, there is a growing need for safe, practical, and nonpharmacological interventions to improve the injection experience in pediatric diabetes care.
This randomized controlled trial aims to investigate the effectiveness of two noninvasive devices-Buzzy and TickleFlex-in reducing pain and fear during insulin injections in children with T1DM. The Buzzy device uses vibration and cold stimulation to reduce pain perception through the gate control mechanism, while the TickleFlex device, a soft and flexible attachment for insulin pens, minimizes needle pressure and distributes the injection sensation evenly.
A total of 90 children aged 6-12 years will be randomly assigned to three groups: Buzzy, TickleFlex, and control. All participants will receive a single subcutaneous insulin injection as part of their regular diabetes management. Pain and fear levels will be measured before and immediately after the injection using validated scales: the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale (CFS), rated independently by the child, parent, and researcher.
It is hypothesized that both Buzzy and TickleFlex will significantly reduce perceived pain and fear compared with standard insulin injection without intervention. Findings from this study are expected to contribute to evidence-based pediatric nursing practices by supporting the integration of nonpharmacological pain management methods into routine diabetes care.
- Conditions
- Diabete Type 1, Diabetes in Children
- Being tested
- Buzzy, TickleFlex, None (Routine Care)
- Keywords
- Type 1 Diabetes Mellitus, Children, Insulin Injection, Pain, Fear, Nonpharmacological Intervention
- Medical subject headings
- Diabetes Mellitus, Type 1, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyDevice
The Buzzy device is a non-invasive, bee-shaped device that combines cold and vibration to reduce pain perception during needle procedures. It was applied for 30 seconds before and during insulin administration to reduce pain and fear according to the gate control theory.
TickleFlexDevice
The TickleFlex device is a soft, flexible insulin-pen attachment that gently stretches the skin and diffuses needle pressure, reducing injection pain and anxiety in children with Type 1 Diabetes Mellitus.
None (Routine Care)Other
Standard subcutaneous insulin injection performed following pediatric diabetes nursing protocols.
| Study group | Role | What they receive |
|---|---|---|
| Buzzy Device Application | Experimental | Participants received vibration and cold stimulation using the Buzzy device before and during insulin injection. Receives: Device: Buzzy |
| TickleFlex Device Application | Experimental | Participants used the TickleFlex device attached to their insulin pens during insulin injection. Receives: Device: TickleFlex |
| Standard Insulin Injection (Control) | Other | Participants received routine insulin injections without any adjunctive device or intervention. Receives: Other: None (Routine Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Insulin Injection
The primary outcome is the level of pain experienced by children during insulin injection, measured using the Wong-Baker FACES Pain Rating Scale (0-10). Assessments are performed independently by the child, parent, and researcher immediately before and after the injection. Higher scores indicate greater pain intensity.
Measured: Immediately before and after a single insulin injection.
Secondary outcomes (1)
Fear Level Associated with Insulin Injection
The secondary outcome is the level of fear experienced by children during insulin injection. Fear is assessed using the Children's Fear Scale (CFS), which scores from 0 (no fear) to 4 (extreme fear). Assessments are conducted independently by the child, parent, and researcher before and immediately after the injection. Lower scores indicate reduced fear levels.
Measured: Immediately before and after a single insulin injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start6 Jun 2025
- Primary completion6 Aug 2025
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized, parallel-assignment interventional model with three arms: Buzzy device application, TickleFlex device application, and control (standard insulin injection).
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hakkari Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrullah AYŞİN, Hakkari Universitesi
- Investigators
- Nesrullah AYŞİN, PHD, Principal investigator, Hakkari University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239700
- Sponsor's protocol ID
- HakkariU-SHMYO-NA-01
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers after publication of the primary results. Requests will be reviewed by the principal investigator to ensure compliance with ethical and data protection standards. Data will include pain and fear scores but exclude any identifiable personal information.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Buzzy and TickleFlex Applications in Reducing Pain and Fear Associated With Insulin Injections in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07239700
- Acronym / sponsor ID
- HakkariU-SHMYO-NA-01
- Conditions
- Diabete Type 1, Diabetes in Children
- Keywords
- Type 1 Diabetes Mellitus, Children, Insulin Injection, Pain, Fear, Nonpharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hakkari UniversitesiUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 20 Nov 2025 (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.
This interventional randomized controlled clinical trial aims to evaluate the effectiveness of two nonpharmacological devices, Buzzy and TickleFlex, in reducing pain and fear associated with insulin injections among children with Type 1 Diabetes Mellitus (T1DM).
A total of 90 participants aged 6 to 12 years will be randomly assigned to one of three groups: Buzzy, TickleFlex, or control. The Buzzy device provides combined cold and vibration stimulation near the injection site to decrease pain perception based on the gate control theory, while the TickleFlex device is a soft, flexible attachment for insulin pens designed to minimize needle pressure and discomfort during injection.
Pain and fear will be assessed immediately before and after a single insulin injection using validated instruments, including the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale (CFS), rated independently by the child, parent, and researcher.
It is hypothesized that both Buzzy and TickleFlex applications will significantly reduce pain and fear compared to standard insulin injection without intervention. The study is expected to provide evidence supporting the use of nonpharmacological methods in pediatric diabetes care to improve children's comfort and treatment adherence.
Detailed description
Children with Type 1 Diabetes Mellitus (T1DM) require multiple daily insulin injections, which are often associated with pain, fear, and anxiety. Repeated exposure to needle-related discomfort can negatively affect children's treatment adherence, emotional well-being, and overall quality of life. Therefore, there is a growing need for safe, practical, and nonpharmacological interventions to improve the injection experience in pediatric diabetes care.
This randomized controlled trial aims to investigate the effectiveness of two noninvasive devices-Buzzy and TickleFlex-in reducing pain and fear during insulin injections in children with T1DM. The Buzzy device uses vibration and cold stimulation to reduce pain perception through the gate control mechanism, while the TickleFlex device, a soft and flexible attachment for insulin pens, minimizes needle pressure and distributes the injection sensation evenly.
A total of 90 children aged 6-12 years will be randomly assigned to three groups: Buzzy, TickleFlex, and control. All participants will receive a single subcutaneous insulin injection as part of their regular diabetes management. Pain and fear levels will be measured before and immediately after the injection using validated scales: the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale (CFS), rated independently by the child, parent, and researcher.
It is hypothesized that both Buzzy and TickleFlex will significantly reduce perceived pain and fear compared with standard insulin injection without intervention. Findings from this study are expected to contribute to evidence-based pediatric nursing practices by supporting the integration of nonpharmacological pain management methods into routine diabetes care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study uses a randomized, parallel-assignment interventional model with three arms: Buzzy device application, TickleFlex device application, and control (standard insulin injection).
| Arm | Type | Receives |
|---|---|---|
| Buzzy Device Application | Experimental | Device: BuzzyParticipants received vibration and cold stimulation using the Buzzy device before and during insulin injection. |
| TickleFlex Device Application | Experimental | Device: TickleFlexParticipants used the TickleFlex device attached to their insulin pens during insulin injection. |
| Standard Insulin Injection (Control) | Other | Other: None (Routine Care)Participants received routine insulin injections without any adjunctive device or intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6 to 12 years.
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 6 months.
- Receiving daily subcutaneous insulin injections as part of routine diabetes management.
- Able to understand and communicate pain and fear levels using the Wong-Baker -FACES Pain Rating Scale and the Children's Fear Scale.
- Accompanied by a parent or legal guardian who can provide informed consent.
Key exclusion criteria (7 listed)
- Presence of neurological, sensory, or cognitive disorders that may affect pain or fear perception.
- Peripheral neuropathy or other diabetic complications influencing pain sensation.
- Use of analgesics, sedatives, or anxiolytic medications within 24 hours prior to data collection.
- Local skin lesions, infections, or allergies at or near the insulin injection site.
- History of needle phobia or severe anxiety disorders diagnosed by a healthcare professional.
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 |
|---|---|---|
| BuzzyThe Buzzy device is a non-invasive, bee-shaped device that combines cold and vibration to reduce pain perception during needle procedures. It was applied for 30 seconds before and during insulin administration to reduce pain and fear according to the gate control theory. | Device | Buzzy Device Application |
| TickleFlexThe TickleFlex device is a soft, flexible insulin-pen attachment that gently stretches the skin and diffuses needle pressure, reducing injection pain and anxiety in children with Type 1 Diabetes Mellitus. | Device | TickleFlex Device Application |
| None (Routine Care)Standard subcutaneous insulin injection performed following pediatric diabetes nursing protocols. | Other | Standard Insulin Injection (Control) |
Primary outcome
Pain Intensity During Insulin Injection
Time frame: Immediately before and after a single insulin injection.
The primary outcome is the level of pain experienced by children during insulin injection, measured using the Wong-Baker FACES Pain Rating Scale (0-10). Assessments are performed independently by the child, parent, and researcher immediately before and after the injection. Higher scores indicate greater pain intensity.
1 secondary outcome
Fear Level Associated with Insulin Injection
Time frame: Immediately before and after a single insulin injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers after publication of the primary results. Requests will be reviewed by the principal investigator to ensure compliance with ethical and data protection standards. Data will include pain and fear scores but exclude any identifiable personal information.
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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.
Nesrullah AYŞİN, PHD principal investigator
Hakkari University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy, TickleFlex and None (Routine Care) in people with Diabete Type 1 and Diabetes in Children, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
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 7 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: enrolling by invitation, as of the sponsor's last update on 20 Nov 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain Intensity During Insulin Injection (time frame: Immediately before and after a single insulin injection.). 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 20 Nov 2025.