Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear

NCT07239700 | Enrolling By Invitation

• 1 other identifier: HakkariU-SHMYO-NA-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Diabete Type 1; Diabetes in Children

Keywords

Type 1 Diabetes Mellitus; Children; Insulin Injection; Pain; Fear; Nonpharmacological Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fear Level Associated with Insulin Injection

  Immediately before and after a single insulin injection.

Study Arms (3)

Buzzy Device Application

EXPERIMENTAL

Participants received vibration and cold stimulation using the Buzzy device before and during insulin injection.

Device: Buzzy

TickleFlex Device Application

EXPERIMENTAL

Participants used the TickleFlex device attached to their insulin pens during insulin injection.

Device: TickleFlex

Standard Insulin Injection (Control)

OTHER

Participants received routine insulin injections without any adjunctive device or intervention.

Other: None (Routine Care)

Interventions

Buzzy DEVICE

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.

Buzzy Device Application

TickleFlex DEVICE

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.

TickleFlex Device Application

None (Routine Care) OTHER

Standard subcutaneous insulin injection performed following pediatric diabetes nursing protocols.

Standard Insulin Injection (Control)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hakkari Universitesi: lead

Study Sites (1)

Hakkari University

Hakkâri, Centre, 65030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pain

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nesrullah AYŞİN, PHD

  Hakkari University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is conducted as an open-label randomized controlled trial. Due to the visible nature of the devices (Buzzy and TickleFlex), participants, parents, and the administering researcher cannot be masked to group assignments. However, outcome assessments are standardized and independently rated by three parties: the child, the parent, and the researcher, using validated pain and fear scales. This approach aims to minimize observer and reporting bias even in the absence of full blinding. No additional parties beyond those listed are masked in this clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a randomized, parallel-assignment interventional model with three arms: Buzzy device application, TickleFlex device application, and control (standard insulin injection).

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: June 6, 2025
• Primary Completion: August 6, 2025
• Study Completion: December 15, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Not applicable. Individual participant data will not be shared.
• 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.

Locations

TU (1)