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

NCT06369649 | Completed

• 1 other identifier: COOLSENSE-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Device: Coolsense and Buzzy

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.

Device: Coolsense and Buzzy

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.

Interventions

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.

Also known as: Buzzy, Coolsense

Buzzy; Coolsense

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 6-10 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Location

Related 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.2021.01.001. Epub 2021 Jan 21.

  PMID: 33485746 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.

  PMID: 30038198 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.

  PMID: 35767175 RESULT

MeSH Terms

Conditions

Iatrophobia; Pain; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mine Nur TEMUÇİN, MSc

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant, faculty of health science

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: April 17, 2024
• Study Start: July 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: March 15, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)