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 range6 Years – 10 Years

SexALL

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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

What they're measuring

Faces Pain Scale- Revised (FPS-R)

Timeframe: just before injection, just after injection

Children's Fear Scale (CFS)

Timeframe: just before injection, just after injection

Trial details

NCT IDNCT06369649

SponsorAnkara Yildirim Beyazıt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-29