Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369649
• Other study ID #: COOLSENSE-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Ankara Yildirim Beyazit University
• Contact: Mine Nur TEMUÇIN, MSc
• Phone: 05537805771
• Email: minenurcakir70[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 147
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Injection Site Coldness
• Nurse's Role
• Pain
• Pediatric Disease
• Type 1 Diabetes Mellitus

Intervention

Device:
• Coolsense and Buzzy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

References & Publications (3)

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. — View 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. — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Heart rate	The child's heart rate was monitored with a monitor and recorded on the application registration form.	just before, during and immediately after the procedure
Primary	Oxygen saturation	The child's oxygen saturation was monitored with a monitor and recorded on the application registration form.	just before, during and immediately after the procedure
Primary	Respiratory rate	The child's respiratory rate was monitored with a monitor and recorded on the application registration form	just before, during and immediately after the procedure
Primary	Blood pressure	The child's blood pressure was monitored with a monitor and recorded on the application registration form.	just before, during and immediately after the procedure