NCT06369649Completed

Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application

Effect of Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application in Children With Type 1 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 20 Feb 2026

Brief summary (registry, in English)

This study aims to determine the effect of using Coolsense, which is created using the proven effect of cold application during insulin injection, and Buzzy, which is a combination of vibration and cold application, in reducing pain and anxiety in children diagnosed with Type 1 diabetes mellitus.This randomized controlled clinical study is planned to be conducted between 05.2024-12.2025 with 147 participants between the ages of 6-12. Participants will be divided into three groups according to the randomization method: buzzy group (n = 49), coolsense group (n = 49) and control group (n = 49). Participants in the Coolsense group will receive a cold application using the coolsense device for 5 seconds before the injection. Participants in the Buzzy group will be subjected to vibration and cold application 30-60 seconds before the procedure. Participants in the control group will continue the clinic's standard procedure. Changes in participants' pain score and fear level, heart rate, blood pressure, respiratory rate and oxygen saturation will be measured at three time points: immediately before and after the procedure. Data descriptive information form, application registration form, Facial Expressions Pain Scale (FPS-R) and Child Fear Scale (CFS) will be used. The collected data will be analyzed using SPSS 15 software. The main questions it aims to answer: * Does buzzy and coolsense application have an effect the pain score of children during the insülin injection? * Does buzzy and coolsense application have an effect the fear score of children during the insülin injection?

Status (registry): Completed
Study type: Interventional
Enrollment: 90 (actual)
First submitted: 5 Feb 2024
Start date: 1 Jul 2023
Primary completion date: 29 Feb 2024
Lead sponsor: Ankara Yildirim Beyazıt University
Diseases: Type 1 diabetes
NCT number: NCT06369649

What you commit to

Study type: Interventional
Participants enrolled: 90
From 1 Jul 2023 to the primary completion date, 29 Feb 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Not having a diagnosis of Type 1 Diabetes
Having a disease that causes chronic pain

Lab values

Blood glucose level should be below 80 mg/dl before application

Age

Being younger than 6 years old and older than 12 years old

Other

Presence of pain before application
The person or the parent does not agree to participate in the research.
Presence of any incision or scar tissue in the area to be injected

Who the study is looking for

Being an inpatient in the Pediatric Endocrinology Service
Having a diagnosis of Type 1 Diabetes Mellitus (no more than 6 months have passed since the diagnosis) receiving insulin therapy
Being in the 6-10 age group.
Having no pain before the application (getting 0 points on the pain scale).
Blood sugar level above 80 mg/dl
Having parental permission
The child's willingness to participate in the research
Not having used any medication that would have an analgesic effect in the last 24 hours before application.
The child does not have a mental or neurological disability
Not having any disease that causes sensitivity to cold, such as Reynaud's syndrome or sickle cell anemia.
The child must be conscious and have no communication problems
The child and the parent must be able to speak Turkish

Age in the registry: 6 years to 10 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Ankara City Hospital Coordinator of this site? Confirm its status	Çankaya	Turkey (Türkiye)	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.