Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabete Type 1; Diabetes in Children
• Intervention / Treatment: Device: Buzzy; Device: TickleFlex; Other: None (Routine Care)

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Centre
    • Hakkâri, Centre, Turkey (Türkiye), 65030
      • Hakkari University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buzzy Device Application; Participants received vibration and cold stimulation using the Buzzy device before and during insulin injection.	Device: Buzzy; 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.
Experimental: TickleFlex Device Application; Participants used the TickleFlex device attached to their insulin pens during insulin injection.	Device: TickleFlex; 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.
Other: Standard Insulin Injection (Control); Participants received routine insulin injections without any adjunctive device or intervention.	Other: None (Routine Care); Standard subcutaneous insulin injection performed following pediatric diabetes nursing protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before and after a single insulin injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before and after a single insulin injection.

Collaborators and Investigators

• Sponsor: Hakkari Universitesi
• Investigators: Principal Investigator: Nesrullah AYŞİN, PHD, Hakkari University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Actual): August 6, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Children; Type 1 Diabetes Mellitus; Fear; Insulin Injection; Nonpharmacological Intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pain; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HakkariU-SHMYO-NA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Not applicable. Individual participant data will not be shared.
• IPD Sharing Access Criteria: Access to de-identified individual participant data (IPD) will be available to qualified researchers who submit a reasonable written request describing the research purpose and data use plan. Requests will be evaluated by the Principal Investigator to ensure compliance with ethical standards, participant privacy, and institutional policies. Approved researchers will receive access to de-identified datasets containing pain and fear scores only, excluding any information that could directly or indirectly identify participants. Data will be shared electronically through secure, password-protected institutional channels.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No