Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369649
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-02-05
Brief Title:
Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application
Sponsor:
Ankara Yildirim Beyazıt University
Organization:
Ankara Yildirim Beyazıt University
Study Overview
Official Title:
Effect of Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application in Children With Type 1 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mellitusThis randomized controlled clinical study is planned to be conducted between 052024-122025 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 clinics 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
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
Detailed Description:
Children between the ages of 6-12 who is diagnosed at least 6 months ago will be included in the studyPatients with intellectual or neurological disabilities Raynaud syndrome or sickle cell anemia will excluded from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None