Clinical trial NCT06369649: Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Injection Fear
Injection Site Coldness
Pain
Type 1 Diabetes Mellitus
Pediatric Disease
Nurse's Role
Keywords: Injection fear
Injection pain
Pain
Type 1 Diabetes Mellitus
Pediatric Disease
Nursing
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 147
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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?

Detailed description: Children between the ages of 6-12, who is diagnosed at least 6 months ago, will be included in the study.Patients with intellectual or neurological disabilities, Raynaud syndrome or sickle cell anemia will excluded from the study.

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

Primary outcomes:
measure: Faces Pain Scale- Revised (FPS-R)
timeFrame: just before injection, just after injection
measure: Children's Fear Scale (CFS)
timeFrame: just before injection, just after injection
measure: Heart rate
timeFrame: just before, during and immediately after the procedure
measure: Oxygen saturation
timeFrame: just before, during and immediately after the procedure
measure: Respiratory rate
timeFrame: just before, during and immediately after the procedure
measure: Blood pressure
timeFrame: just before, during and immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Mine Nur TEMUÇİN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.