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NCT Number: NCT06369649

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

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?

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Key information

Conditions

Injection Fear Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Iatrophobia Immune System Diseases Injection Site Coldness Metabolic Diseases Neurologic Manifestations Nurse's Role Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Pediatric Disease Signs and Symptoms Type 1 Diabetes Mellitus

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

About this study

Children between the ages of 6-10, who is diagnosed at least 2 weeks ago, will be included in the study.Patients with intellectual or neurological disabilities, Raynaud syndrome or sickle cell anemia will excluded from the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 6-10 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

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

Treatment and study plan

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.

Other names: Buzzy, Coolsense

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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