protocolSection identificationModule nctId: NCT06369649, orgStudyIdInfo id: COOLSENSE-1, briefTitle: Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: 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?* Does buzzy and coolsense application have an effect the heart rate of children during the insülin injection?* Does buzzy and coolsense application have an effect the oxygen saturation of children during the insülin injection?* Does buzzy and coolsense application have an effect the blood pressure of children during the insülin injection?* Does buzzy and coolsense application have an effect the respiratory rate of children during the insülin injection?, conditionsModule conditions: Injection Fear, conditions: Injection Site Coldness, conditions: Pain, conditions: Type 1 Diabetes Mellitus, conditions: Pediatric Disease, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Single blinding (participants) will be used in the research and the researchers will not have information about the other group.While applying both scales, care will be taken to ensure that children, parents and observers do not see each other's evaluations and are not influenced by each other. In this way, the child, parent and independent observer will score blindly before and after the procedure., whoMasked: PARTICIPANT, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Coolsense and Buzzy, outcomesModule primaryOutcomes measure: Faces Pain Scale- Revised (FPS-R), primaryOutcomes measure: Children's Fear Scale (CFS), primaryOutcomes measure: Heart rate, primaryOutcomes measure: Oxygen saturation, primaryOutcomes measure: Respiratory rate, primaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False