InjectionNCT07418021
Effects of Cold Spray and Buzzy Device an Pain and Fear During Penicillin Injection
A study testing Cold Spray Intervention Group and Buzy Device Intervention Group in people with Injection and Pain Management, run by Inonu University.
Trial summary
This study investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injection, Pain Management, Fear
- What is being tested?
- Cold Spray Intervention Group and Buzy Device Intervention Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2026to 5 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Individuals scheduled to receive intramuscular penicillin injection
- Able to communicate and report pain and fear levels
- Willing to participate in the study
- Provided written informed consent
Who cannot join
- Known allergy or hypersensitivity to cold applications
- Skin lesions, infection, or injury at the injection site
- Neurological or psychiatric conditions that may affect pain or fear perception
- Use of analgesic or anxiolytic medication prior to injection
- Previous adverse reaction to intramuscular injections
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zeliha CENGIZ, Associate Professor Dr. contact
About this study
Official title: The Effect of Innovative Cold Applications (Cold Spray and Buzzy Device) on Pain and Fear Associated With Penicillin Injection: A Randomized Controlled Trial
This study investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Penicillin injections are commonly used in clinical practice and can cause discomfort, pain, and fear, particularly in patients receiving intramuscular injections.
Cold spray and Buzzy devices are non-pharmacological methods that can help reduce pain and fear by providing a cooling effect and vibration at the injection site. Participants will be randomly assigned to one of the study groups, and their pain and fear levels during injection will be assessed using standardized measurement tools.
The results of this study are expected to contribute to improving patient comfort and supporting the use of simple, non-invasive methods to reduce pain and fear during injections.
Read the detailed description
This randomized controlled study will be conducted to evaluate the effects of cold spray and the Buzzy device on pain and fear associated with penicillin injection. Eligible participants who require intramuscular penicillin injection will be randomly assigned to one of the study groups: cold spray, Buzzy device, or routine care (control group).
In the cold spray group, a topical cold spray will be applied to the injection site immediately before the injection. In the Buzzy device group, the Buzzy device will be placed near the injection site to provide cold and vibration during the injection. Participants in the control group will receive the injection according to standard clinical practice without any additional intervention.
Pain and fear levels will be assessed during the injection process using validated measurement tools. Data collection will be carried out by trained researchers following standardized procedures. The study will be conducted in accordance with ethical principles and relevant clinical research guidelines.
- Conditions
- Injection, Pain Management, Fear
- Being tested
- Cold Spray Intervention Group, Buzy Device Intervention Group, Control Group
- Keywords
- Pain, Injection, Injection fear
- Medical subject headings
- Agnosia, Pain, Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Spray Intervention GroupOther
Cold spray application
Buzy Device Intervention GroupOther
Buzzy device application
Control GroupOther
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | In the Control group, a standard intramuscular penicillin injection is administered without any additional pain management intervention. All injections are performed using a standardized technique by the same nurse to ensure consistency. Receives: Other: Control Group |
| Cold Spray Intervention Group | Experimental | Two minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection. Receives: Other: Cold Spray Intervention Group |
| Buzy Device Intervention Group | Experimental | Two minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection. Receives: Other: Buzy Device Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain Intensity
Procedural pain intensity will be measured using a 10-centimeter Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "unbearable pain."
Measured: Within one minute before the penicillin injection procedure.
Secondary outcomes (1)
Level of Procedural Fear
The level of fear regarding the injection will be assessed using the Visual Analog Scale (VAS-Fear), where 0 indicates "no fear" and 10 indicates "extreme fear." This assessment will be performed both before the procedure (pre-test) and after the procedure (post-test).
Measured: Immediately before the procedure and within 1 minute after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion5 Apr 2026 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InjectionStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled experimental study with 3 groups.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418021
- Sponsor's protocol ID
- 2025/8735
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz GN, Ciftci B; Development of the Injection Fear Scale; Proceedings of the 1st International Uludağ Scientific Research Congress; 2023:1-2.
Çetin MM, Avşar G; Evaluation of the effect of cold spray application on injection pain during intramuscular penicillin injection; Mersin University Journal of Health Sciences; 2022;15(3):573-583.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Innovative Cold Applications (Cold Spray and Buzzy Device) on Pain and Fear Associated With Penicillin Injection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07418021
- Acronym / sponsor ID
- 2025/8735
- Conditions
- Injection, Pain Management, Fear
- Keywords
- Pain, Injection, Injection fear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 5 Apr 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 18 Feb 2026 (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 investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Penicillin injections are commonly used in clinical practice and can cause discomfort, pain, and fear, particularly in patients receiving intramuscular injections.
Cold spray and Buzzy devices are non-pharmacological methods that can help reduce pain and fear by providing a cooling effect and vibration at the injection site. Participants will be randomly assigned to one of the study groups, and their pain and fear levels during injection will be assessed using standardized measurement tools.
The results of this study are expected to contribute to improving patient comfort and supporting the use of simple, non-invasive methods to reduce pain and fear during injections.
Detailed description
This randomized controlled study will be conducted to evaluate the effects of cold spray and the Buzzy device on pain and fear associated with penicillin injection. Eligible participants who require intramuscular penicillin injection will be randomly assigned to one of the study groups: cold spray, Buzzy device, or routine care (control group).
In the cold spray group, a topical cold spray will be applied to the injection site immediately before the injection. In the Buzzy device group, the Buzzy device will be placed near the injection site to provide cold and vibration during the injection. Participants in the control group will receive the injection according to standard clinical practice without any additional intervention.
Pain and fear levels will be assessed during the injection process using validated measurement tools. Data collection will be carried out by trained researchers following standardized procedures. The study will be conducted in accordance with ethical principles and relevant clinical research guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized controlled experimental study with 3 groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupIn the Control group, a standard intramuscular penicillin injection is administered without any additional pain management intervention. All injections are performed using a standardized technique by the same nurse to ensure consistency. |
| Cold Spray Intervention Group | Experimental | Other: Cold Spray Intervention GroupTwo minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection. |
| Buzy Device Intervention Group | Experimental | Other: Buzy Device Intervention GroupTwo minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Individuals scheduled to receive intramuscular penicillin injection
- Able to communicate and report pain and fear levels
- Willing to participate in the study
- Provided written informed consent
Key exclusion criteria (5 listed)
- Known allergy or hypersensitivity to cold applications
- Skin lesions, infection, or injury at the injection site
- Neurological or psychiatric conditions that may affect pain or fear perception
- Use of analgesic or anxiolytic medication prior to injection
- Previous adverse reaction to intramuscular injections
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 |
|---|---|---|
| Cold Spray Intervention GroupCold spray application | Other | Cold Spray Intervention Group |
| Buzy Device Intervention GroupBuzzy device application | Other | Buzy Device Intervention Group |
| Control GroupStandard care | Other | Control Group |
Primary outcome
Procedural Pain Intensity
Time frame: Within one minute before the penicillin injection procedure.
Procedural pain intensity will be measured using a 10-centimeter Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "unbearable pain."
1 secondary outcome
Level of Procedural Fear
Time frame: Immediately before the procedure and within 1 minute after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Results publicationYildiz GN, Ciftci B; Development of the Injection Fear Scale; Proceedings of the 1st International Uludağ Scientific Research Congress; 2023:1-2.
- Results publicationÇetin MM, Avşar G; Evaluation of the effect of cold spray application on injection pain during intramuscular penicillin injection; Mersin University Journal of Health Sciences; 2022;15(3):573-583.
Related trials for Injection
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
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.
Zeliha CENGIZ, Associate Professor Dr. contact
Questions about this trial
What is this clinical trial studying?
A study testing Cold Spray Intervention Group and Buzy Device Intervention Group in people with Injection and Pain Management, run by Inonu University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeliha CENGIZ, Associate Professor Dr. (+90543 327 7494 ext. +90543 327 749, zeliha.cengiz@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Pain Intensity (time frame: Within one minute before the penicillin injection procedure.). 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 NCT07418021, which also lists 2 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 18 Feb 2026.