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

Launched by ANKARA YILDIRIM BEYAZIT UNIVERSITY · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two methods, called Coolsense and Buzzy, to help reduce pain and anxiety in children with Type 1 diabetes during insulin injections. Coolsense uses cold application for a short time before the injection, while Buzzy combines cold and vibration for a little longer. The researchers want to see if these methods make the injection experience less painful and scary for kids aged 6 to 12. The study will include 147 participants, who will be randomly divided into three groups: one will use Buzzy, another will use Coolsense, and the last group will follow the usual procedure without special techniques.

To be eligible for the trial, children must be diagnosed with Type 1 diabetes within the last six months, be between 6 and 12 years old, and not have any pain before the injection. They should also have a blood sugar level above 80 mg/dl and need permission from a parent to participate. Throughout the study, researchers will measure changes in pain and fear levels, as well as other health indicators like heart rate and blood pressure, before and after the injections. This trial aims to better understand how effective these techniques are in making insulin injections easier for children.

Gender

ALL

Eligibility criteria

• 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 6-12 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