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
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?
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ankara Yildirim Beyazit University |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|