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

April 15, 2024 updated by: Mine Nur Temuçin, Ankara Yildirim Beyazıt University

Effect of Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application in Children With Type 1 Diabetes Mellitus

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coolsense
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
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.
Other Names:
  • Buzzy
  • Coolsense
Experimental: Buzzy
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
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.
Other Names:
  • Buzzy
  • Coolsense
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faces Pain Scale- Revised (FPS-R)
Time Frame: just before injection, just after injection
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)
Time Frame: just before injection, just after injection
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
Heart rate
Time Frame: just before, during and immediately after the procedure
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
Oxygen saturation
Time Frame: just before, during and immediately after the procedure
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
Respiratory rate
Time Frame: just before, during and immediately after the procedure
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
Blood pressure
Time Frame: just before, during and immediately after the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Mine Nur TEMUÇİN, MSc, Ankara Yildirim Beyazıt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COOLSENSE-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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