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

Not Applicable

Not yet recruiting

• Conditions: Pediatric Disease; Injection Fear; Injection Site Coldness; Type 1 Diabetes Mellitus; Pain; Nurse's Role

• Registration Number: NCT06369649
• Lead Sponsor: Ankara Yildirim Beyazıt University

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.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Study Start: 2024-06-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate	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.
Oxygen saturation	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.
Blood pressure	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.
Children's Fear Scale (CFS)	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.
Faces Pain Scale- Revised (FPS-R)	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.
Respiratory rate	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