Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application (NCT06369649) | Clinical Trial Compass
CompletedNot Applicable
Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application
Turkey (Türkiye)90 participantsStarted 2023-07-01
Plain-language summary
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?
Who can participate
Age range
6 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Being younger than 6 years old and older than 12 years old
* Not having a diagnosis of Type 1 Diabetes
* Presence of pain before application
* Blood glucose level should be below 80 mg/dl before application
* The person or the parent does not agree to participate in the research.
* Having a disease that causes chronic pain
* Presence of any incision or scar tissue in the area to be injected
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My child needs regular insulin injections for Type 1 diabetes — could using a cold spray like Coolsense or a vibrating device like Buzzy before each injection realistically reduce their pain and fear, based on what this completed study found?
2Since this trial measured children's pain using the Faces Pain Scale and fear using the Children's Fear Scale, what did the results actually show about how well these two methods worked compared to each other or to doing nothing?
3My child has developed a real fear of their insulin injections — would my doctor think a device like Buzzy, which uses both vibration and cold, might be worth trying as part of our current routine, or is there a better approach they'd recommend first?
4Since this trial specifically looked at the nurse's role in using these techniques, would it be something our diabetes care nurse could help us try at home or during clinic visits, and how would we get access to the right device?
5Are there any children who this kind of approach might not be suitable for — for example, kids with certain skin sensitivities or very high injection anxiety — so I can understand whether it's realistic to discuss this for my child specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Faces Pain Scale- Revised (FPS-R)
Timeframe: just before injection, just after injection
2
Children's Fear Scale (CFS)
Timeframe: just before injection, just after injection