Effects of Cold Spray and Buzzy Device an Pain and Fear During Penicillin Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold Spray Intervention Group, Buzy Device Intervention Group, Control Group.
- Who it may be relevant to
- Registry conditions: Injection, Pain Management, Fear. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Cold Spray Intervention Group
Cold spray application - Other Buzy Device Intervention Group
Buzzy device application - Other Control Group
Standard care
Primary outcome measures
- Procedural Pain Intensity [Time frame: Within one minute before the penicillin injection procedure.]
Secondary outcome measures (1)
- Level of Procedural Fear [Time frame: Immediately before the procedure and within 1 minute after the procedure.]
Eligibility criteria
Eligibility Criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
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.
Identifiers
NCT: NCT07418021 · 2025/8735