Injection FearNCT06369649
Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application
A study testing Coolsense and Buzzy in people with Injection Fear and Injection Site Coldness, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Fear, Injection Site Coldness, Pain
- What is being tested?
- Coolsense and Buzzy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the detailed description
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.
- Conditions
- Injection Fear, Injection Site Coldness, Pain, Type 1 Diabetes Mellitus, Pediatric Disease, Nurse's Role
- Being tested
- Coolsense and Buzzy
- Keywords
- Injection fear, Injection pain, Pain, Type 1 Diabetes Mellitus, Pediatric Disease, Nursing
- Medical subject headings
- Iatrophobia, Pain, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coolsense and BuzzyDevice
Also called Buzzy, Coolsense
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: just before injection, just after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jul 2023
- Primary completion29 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Injection FearStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Nur Temuçin, Ankara Yildirim Beyazıt University
- Investigators
- Mine Nur TEMUÇİN, MSc, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369649
- Sponsor's protocol ID
- COOLSENSE-1
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33485746Susam 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.
PubMed 30038198Xess 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.
PubMed 35767175
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06369649
- Acronym / sponsor ID
- COOLSENSE-1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coolsense | Experimental | Device: Coolsense and BuzzyFor 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. |
| Buzzy | Experimental | Device: Coolsense and BuzzyFor 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. |
| 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coolsense and BuzzyAlso: Buzzy, CoolsenseBefore 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. | Device | Buzzy, Coolsense |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 33485746Erdogan 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.
- Results publication: PubMed 30038198Susam 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.
- Results publication: PubMed 35767175Xess 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine Nur TEMUÇİN, MSc principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coolsense and Buzzy in people with Injection Fear and Injection Site Coldness, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces Pain Scale- Revised (FPS-R) (time frame: just before injection, just after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369649, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.