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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:
Children between the ages of 6-10, who is diagnosed at least 2 weeks ago, will be included in the study.Patients with intellectual or neurological disabilities, Raynaud syndrome or sickle cell anemia will excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coolsense | Experimental | For children in this group, the standard approach of the clinic will be applied first. The researcher will apply scales to the child before the procedure, the Child-Parent Information Form to the parents, and the child, parent and independent observer before and after the procedure. The patient's physiological parameters will be recorded by the nurse performing the procedure before, during and after the procedure. The device, which is removed from the freezer just before the injection, will be applied by the researcher to the skin surface where the procedure will be performed for approximately 5-10 seconds before the injection, and then the injection will be performed. |
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| Buzzy | Experimental | For children in this group, the standard approach of the clinic will be applied first. The researcher will apply scales to the child before the procedure, the Child-Parent Information Form to the parents, and the child, parent and independent observer before and after the procedure. The patient's physiological parameters will be recorded by the nurse performing the procedure before, during and after the procedure. The device, which will be removed from the freezer just before the injection, will be placed by the researcher in contact with the skin, 3 to 5 cm above the injection site. Buzzy will be started 30-60 seconds before the process and will continue until the end of the process. |
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| Control | No Intervention | For children in this group, the standard approach of the clinic will be applied first. The researcher will apply scales to the child before the procedure, the Child-Parent Information Form to the parents, and the child, parent and independent observer before and after the procedure. The patient's physiological parameters will be recorded by the nurse performing the procedure before, during and after the procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coolsense and Buzzy | Device | Before the procedure, the independent observer, parent and child will be informed by the researcher about the method that will be used in the selected group and the scales that they will score. For children and parents in each group, a standard approach will be applied. Single blinding (participants) will be used in the research and the researchers will not have information about the other group. Cold application will be applied to children in group number one (Coolsense group). Coolsense, which does not contain any chemicals, provides cold application with the metal piece on its tip. In group number two (Buzzy group), vibration and cold application will be applied to the children. Buzzy is a handheld device with a bee-shaped motor that creates a small cold pad and vibration in the area in contact with the skin surface. Group number three (control group) will continue the standard procedure of the clinic and no different application or approach will be applied. |
| Measure | Description | Time Frame |
|---|---|---|
| Faces Pain Scale- Revised (FPS-R) | It consists of facial expressions to evaluate pain intensity and is used in children aged four years and above. The scale consists of six simplified facial expressions that indicate the intensity of pain at increasing levels from 0 to 10 (0-2-4-6-8-10). In the scale, the child is asked to show the facial expression that best describes the intensity of pain. 0 means no pain, 10 means no pain indicates severe pain. | just before injection, just after injection |
| Children's Fear Scale (CFS) | The scale used to evaluate the level of anxiety in children is a visual measurement tool that consists of five drawn facial expressions ranging from neutral expression (0 = no anxiety) to scared face (4 = severe anxiety) and receives a score of 0-4 points. As the score obtained from the scale increases, the severity of anxiety increases, and as the score decreases, anxiety decreases. | just before injection, just after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mine Nur TEMUÇİN, MSc | Ankara Yildirim Beyazıt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital | Çankaya | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33485746 | Result | Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21. | |
| 30038198 | Result | Susam V, Friedel M, Basile P, Ferri P, Bonetti L. Efficacy of the Buzzy System for pain relief during venipuncture in children: a randomized controlled trial. Acta Biomed. 2018 Jul 18;89(6-S):6-16. doi: 10.23750/abm.v89i6-S.7378. |
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| ID | Term |
|---|---|
| C000719205 | Iatrophobia |
| D010146 | Pain |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
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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.
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| 35767175 | Result | Xess PA, Sarna R, Sethi S, Chauhan R, Meena SC, Saini V, Luthra A, Singh N. Effect of CoolSense and EMLA Cream on Pain During Intravenous Cannulation in Pediatric Population: A Randomized, Controlled Trial. Indian J Pediatr. 2024 Feb;91(2):119-124. doi: 10.1007/s12098-022-04233-w. Epub 2022 Jun 29. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |